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A critical review on magnetic stimulation: What is its role in the management of pelvic floor disorders?
Abstract
This review looks at the acute effects of magnetic stimulation on urodynamic parameters and reviews the data on its use in the management of urinary incontinence.
Reported cure rates for stress incontinence immediately after a course of perineal magnetic stimulation range from 12.5 to 52.9% with good improvement occurring in 32% to 41%. However the effect seems temporary and dependent on the number of sessions. Sacral and pelvic floor magnetic stimulation have also been shown to increase cystometric capacity, inhibit detrusor overactivity and resolve overactive bladder symptoms acutely. Persistence of this effect with symptomatic improvement one week after sacral magnetic stimulation has been demonstrated. How magnetic stimulation suppresses detrusor contraction is not known. Prospective trials with the Neocontrol chair (Neotonus Inc, Marietta, Georgia, USA) also showed symptomatic improvement in 71 to 87% in the short term. However, the longer term data appear mixed.
Overall, the data available vary too much in terms of treatment protocols, patient mix and symptom severity to determine which group of patients might benefit most and what the optimal stimulation parameters are for each condition. Mean reductions in leak parameters, although statistically significant, may not always be clinically satisfactory. The beneficial effects also appear to be temporary and continuous treatment will probably be required. Further trials are needed to determine the optimum stimulation protocols for different situations and to compare magnetic stimulation with other forms of conservative pelvic floor therapy.
... However, in the last decade, other treatment modalities have been described, such as electromagnetic therapy, which poses a novel approach, presenting the same underlying effect as electric stimulation, due to the interaction with the nervous system, although, in this case, the electromagnetic field goes non-invasively through the neuromuscular tissue, where the induced electric currents depolarize the neural cells, thus altering the resting membrane potential and, thereby, reducing the transmission of painful impulses [11,12]. ...
... Magnetic stimulation of the pelvis produces a direct stimulus in muscular trophism, favoring an anti-inflammatory effect, in addition to its relaxing and de-contracting effect, as it reduces the sympathetic tone; thus, restoring the normal muscular activity of the pelvic floor [11,13]. ...
... This therapy poses a novel and promising approach for the treatment of CPP/CPPS, given its multiple benefits; where low intensities (10-20 Hz) are associated with analgesic and myorelaxant effects, whereas medium-high intensities (≥50 Hz) are more strongly related to an anti-inflammatory and tissue-repairing effect [11,14,15]. ...
Chronic pelvic pain (CPP), also known as chronic pelvic pain syndrome (CPPS), is a common and painful condition. However, its treatment is still a challenge. The findings about the beneficial effects of electromagnetic therapy provide a new, potentially valid, therapeutic alternative for the management of patients with CPP.
Objectives:
to analyze the efficacy of magnetic field therapy in pain reduction in patients with CPP and for other variables, such as urinary symptoms and quality of life, as well as to review the evidence, in order to establish an action protocol. A qualitative systematic review was carried out, based on the PRISMA protocol and registered in PROSPERO (CRD42022285428). A search was performed in the PubMed, Medline, Scopus, Cochrane, PEDro, BVS, and WOS databases, including those articles in which the patients suffered from CPP; the study variable was pain, and the intervention was based on the application of magnetic fields.
Results:
Among the 81 articles found, five clinical trials were considered (with an average score of 7.2 in the PEDro scale), with a total of 278 participants, most of whom presented improvements in perceived pain (p ≤ 0.05), as well as in quality of life (p < 0.05) and urinary symptoms (p = 0.05), evaluated through the NIH-CPSI and VAS scales. The therapy was conducted as a monotherapy or in combination with a pharmacological treatment. There was no common protocol among the different articles.
Conclusions:
Intervention programs through electromagnetic therapy, on their own or with other therapies, can be effective in patients with CPP.
... Magnetic stimulation (MS) is a novel approach approved as a conservative treatment for UI by the United States Food and Drug Administration since 1998. 10 Since then, over 50 clinical studies have been conducted worldwide to evaluate its efficacy in UI. 11 Clinicians, healthcare providers and policy makers are overwhelmed by the multitude of information and there is a need to amalgamate these information to allow for evidencebased decision making. To date, no systematic review has been performed to specifically assess the efficacy of MS for UI. ...
... Although many reviews have been published on nonsurgical therapies for UI, 11,25-28 none specifically addressed our question of interest. Quek et al. (2005) provided an overview of the basic principles of MS, possible therapeutic applications and a brief summary of treatment efficacy. 11 We further identified three systematic reviews on conservative therapies for UI. ...
... Quek et al. (2005) provided an overview of the basic principles of MS, possible therapeutic applications and a brief summary of treatment efficacy. 11 We further identified three systematic reviews on conservative therapies for UI. Two systematic reviews published on SUI 29 and UUI 25 did not discuss MS since this modality was not yet available then. 10 A more recent systematic review only briefly addressed the effects of MS on UI. 9 Shamliyan et al. (2008) assessed 12 RCTs on physical rehabilitation therapies and concluded that MS or ES was no more superior than sham stimulation or PFMT. ...
AimsTo review whether patients with urinary incontinence (UI) treated with magnetic stimulation (MS) have a higher continence rate compared to sham.Methods
Computerized search of electronic databases was performed using the keywords magnetic stimulation therapy and urinary incontinence. Inclusion criteria were randomized, blinded and sham-controlled.ResultsEight studies involving 494 patients were included (285 patients received active MS and 209 patients received sham MS). Sample size ranged from 20 to 151 participants. Three studies were on stress UI, two studies on urgency UI, two studies on mixed UI and one study on overactive bladder. The primary outcome (cure) was not reported since only one study reported this outcome. Meta-analysis of the secondary outcome (improvement) showed patients who received active treatment were 2.3 times more likely to experience improved continence compared to sham treatment (95% confidence interval: 1.60-3.29; P < 0.001), but was subject to bias due to varying inclusion criteria, poor reporting and variable time points. There were conflicting results in the treatment effect on quality of life (QOL). Twenty out of 494 patients (5%) experienced mild side effects. The longest follow up period was six months.Conclusions
There is no firm evidence to support the benefits of using MS in the management of UI, although short-term outcomes suggests that MS improves UI symptoms in women. The applicability of MS as a treatment option for UI remains uncertain until larger, high-quality trials with longer follow-up periods using comparable and relevant outcomes are conducted. Neurourol. Urodynam. © 2014 Wiley Periodicals, Inc.
... Pulsed magnetic stimulation is a non-invasive treatment in which patients can undergo a procedure while fully clothed [46]. The changing magnetic field leads to pelvic floor nerve stimulation and repetitive PFM contractions [47] similar to PFMT. Lim et al. [28] found that pulsed magnetic stimulation applied for SUI in 35 women involved in 2 sessions per week for 2 months (16 sessions, 20 min each with 50 Hz in an 8 s on 4 s off pulsing manner) improved physical, social and psychological aspects of QoL [28]. ...
... Even though magnetic stimulation is widely used in the treatment of UI [23,[28][29][30][31]34,[46][47][48][49][50], it is necessary to evaluate the indications and contraindications of this technique [51]. ...
Background:
There is strong evidence that specific pelvic floor muscle training (PFMT) reduces stress urinary incontinence (SUI), but the application of functional magnetic stimulation (FMS) is still under discussion.
Objective:
To evaluate and compare the effects of FMS and PFMT on pelvic floor muscle function, urinary incontinence symptoms and quality of life (QoL) in women with SUI.
Methods:
A randomized controlled, parallel-group trial was executed in an outpatient physical medicine and rehabilitation centre. The study included 68 women and was fully completed by 48 women (n = 24 in each group) aged 29-49 years, with SUI, who were randomly assigned to PFMT and FMS groups. The symptoms of urinary incontinence and their impact on quality of life were assessed with two questionnaires: the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and the Incontinence Impact Questionnaire-Short Form (IIQ-7). Perineometer (Pelvexiser) was used to measure the resting vaginal pressure, pelvic floor muscle (PFM) strength and endurance. All outcome measures were taken at baseline and after 6 weeks of interventions. Cohen's effect size (d) was calculated.
Results:
A significant improvement (p < 0.05) of ICIQ-SF and IIQ-7 was observed in both groups with a high effect size in the PFMT group (d = 1.56 and d = 1.17, respectively) and the FMS group (d = 1.33 and d = 1.45, respectively). ICIQ-SF and IIQ-7 scores did not differ significantly between groups after the 6-week treatment period. Resting vaginal pressure, PFM strength and endurance increased (p < 0.05) in both groups with a medium (d = 0.52) to large (d = 1.56) effect size.
Conclusion:
No significant difference between groups was found in any measurement of perineometry. PFMT and FMS significantly improved SUI symptoms and the quality of life of the study participants. None of the applied interventions was superior to the other in the short-term effect.
... MS is a noninvasive, passive method of stimulating the roots of the sacral nerves or PFMs [104]. The MS method uses a special chair with a therapeutic head placed in the seat; as the magnetic field can penetrate through clothes, stimulation can be carried out in clothing, which significantly increases the comfort of therapy [105]. The head creates a magnetic field that penetrates the pelvic organs, acting directly on the motor fibers of the nerves. ...
... Lower frequencies (5-10 HZ), as in ES, are used to inhibit detrusor activity, while higher are effective in stimulating PFM contraction and closing the urethra [112,120]. MS is an alternative to electrical stimulation (ES); however, compared to ES, it is a painless method and more comfortable for the patient [105]. MS is assessed by patients with SUI as a well-tolerated and satisfactory method [121]. ...
Urinary incontinence (UI) is a common health problem affecting quality of life of nearly 420 million people, both women and men. Pelvic floor muscle (PFM) training and other physiotherapy techniques play an important role in non-surgical UI treatment, but their therapeutic effectiveness is limited to slight or moderate severity of UI. Higher UI severity requires surgical procedures with pre- and post-operative physiotherapy. Given that nearly 30%–40% of women without dysfunction and about 70% with pelvic floor dysfunction are unable to perform a correct PFM contraction, therefore, it is particularly important to implement physiotherapeutic techniques aimed at early activation of PFM. Presently, UI physiotherapy focuses primarily on PFM therapy and its proper cooperation with synergistic muscles, the respiratory diaphragm, and correction of improper everyday habits for better pelvic organ support and continence. The purpose of this work is a systematic review showing the possibilities of using physiotherapeutic techniques in the treatment of UI in women with attention to the techniques of PFM activation. Evidence of the effectiveness of well-known (e.g., PFM training, biofeedback, and electrostimulation) and less-known (e.g., magnetostimulation, vibration training) techniques will be presented here regarding the treatment of symptoms of urinary incontinence in women.
... The mechanism of action of MStim is not fully understood (163). Some authors have suggested that in SUI stimulation of the PFM causes external sphincter contraction (164), acts as a passive PFMT exercise (165), and increases maximal urethral closure pressure (162). ...
... Prevention of UI ....................................... 163 1.2. Treatment of UI ........................................ 1631.2.1 Is PTNS Better Than No Treatment,Placebo or Control Treatments for UI? ..163 ...
https://www.ics.org/publications/ici_6/Incontinence_6th_Edition_2017_eBook_v2.pdf
... It is thought that MFS suppresses detrusor contraction through various pathways that inhibit the micturition reflex. In response to filling of the bladder, increased activity of the urethral sphincter induces relaxation of the detrusor muscle, as afferent branches of the nerves of the muscles of the limbs prohibit voiding during fight-or-flight reactions and afferent anorectal nerve branches prohibit voiding during defecation, also there is increased activity of the sympathetic nervous system in response to filling of the bladder (Edvardsen's reflex) [9]. ...
... Quek [9] concluded that magnetic stimulation penetrates tissues without alteration and only declines as the inverse square of the distance, unlike direct electrical stimulation that decreases as a function of tissue impedance. Thus, magnetic stimulation has a greater effect on neural tissue at greater depths and with less discomfort at the point of application. ...
Objective: To compare the effectiveness of pulsed electromagnetic field therapy (PEMFT) and transcutaneous electrical nerve stimulation (TENS) on neurogenic overactive bladder dysfunction (OAB) in patients with spinal cord injury (SCI).
Patients and methods: In all, 80 patients [50 men and 30 women, with a mean (SD) age of 40.15 (8.76) years] with neurogenic OAB secondary to suprasacral SCI were included. They underwent urodynamic studies (UDS) before and after treatment. Patients were divided into two equal groups: Group A, comprised 40 patients who received 20 min of TENS (10 Hz with a 700 s generated pulse), three times per week for 20 sessions; Group B, comprised 40 patients who received PEMFT (15 Hz with 50% intensity output for 5 s/min for 20 min), three times per week for 20 sessions.
Results: In Group B, there was a significant increase in the maximum cystometric capacity (P
... The mechanism of action of MStim is not fully understood (163). Some authors have suggested that in SUI stimulation of the PFM causes external sphincter contraction (164), acts as a passive PFMT exercise (165), and increases maximal urethral closure pressure (162). ...
... Prevention of UI ....................................... 163 1.2. Treatment of UI ........................................ 1631.2.1 Is PTNS Better Than No Treatment,Placebo or Control Treatments for UI? ..163 ...
... The mechanism of action of MStim is not fully understood (163). Some authors have suggested that in SUI stimulation of the PFM causes external sphincter contraction (164), acts as a passive PFMT exercise (165), and increases maximal urethral closure pressure (162). ...
... Prevention of UI ....................................... 163 1.2. Treatment of UI ........................................ 1631.2.1 Is PTNS Better Than No Treatment,Placebo or Control Treatments for UI? ..163 ...
https://www.ics.org/Publications/ICI_5/INCONTINENCE.pdf
... During this consistent trajectory, a sufficiently large membrane depolarization will result in an action potential along the nerve tissues. In the pelvic floor, this leads to pelvic floor nerve stimulation (stimulation of motor end plates) and ultimately pelvic floor muscle contraction [11,23]. In both groups, treatment involves two sessions of 20 minutes each per week for 8 weeks (16 sessions total). ...
... MS is a non-invasive procedure and has been shown to be effective in SUI in various open-label studies [23]. Further advantages are no reported adverse events, unnecessary to undress, automatic contractions and no pain. ...
There is currently a lack of randomized, sham-controlled trials that are adequately powered, using validated outcomes, to allow for firm recommendations on the use of magnetic stimulation for stress urinary incontinence. We report a protocol of a multicenter, randomized, double-blind, sham-controlled parallel-group trial to evaluate the efficacy of magnetic stimulation for stress urinary incontinence.
One hundred twenty subjects with stress urinary incontinence will be randomized in a 1:1 allocation to either active or sham magnetic stimulation using computer-generated, permuted blocks of variable sizes. Subjects will receive 2 sessions of magnetic stimulation per week for 8 weeks (16 sessions total). The primary outcome is the improvement in severity of involuntary urine loss based on the International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form at the end of treatment sessions compared with baseline. Secondary outcomes include cure, stress urinary incontinence-related symptoms (incontinence episode frequency, urine loss in 1-hour pad test, pelvic floor muscle strength) and health-related quality of life (Patient Global Impression of Improvement, International Consultation on Incontinence Questionnaire-Lower Urinary Tract Symptoms Quality of Life and EQ-5D). The safety of magnetic stimulation will also be assessed. Besides evaluation of clinical treatment effectiveness, cost-effectiveness analysis using patient-reported outcomes will be performed.
This trial is designed to provide pending outcome information on this non-invasive treatment option. We intend to acknowledge the existing flaws in previous clinical trials and determine conclusively whether magnetic stimulation is effective for stress urinary incontinence.
ClinicalTrials.gov Identifier: NCT01924728 . Date of Registration: 14 August 2013.
... Magnetic stimulation is considered to have an even greater effect due to deeper penetration into tissue compared to electrical stimulation. It is also a noninvasive, relatively painless, safe and simple method, without side effects and can be performed as an outpatient procedure without the need to undress the patient as the magnetic field can pass through clothing 12 . The role of pelvic floor FMS has already been investigated in patients with UI after RP, al-though the number of published studies on this topic is very limited, but they have generally shown a beneficial effect of FMS alone or in combination with other treatment modalities for UI, mostly shortening the time from surgery to postoperative urinary continence, by increasing maximal urethral closure pressure, reducing or inhibiting detrusor overactivity, and increasing functional bladder capacity 13,14 . ...
Although radical prostatectomy is considered the gold standard for optimal treatment of localized prostate cancer, this radical surgery carries a significant risk of erectile dysfunction and urinary incontinence which can be present as transient or permanent side effects in many patients. We have made significant advances in diagnostic and surgical approach to prostate cancer, using a number of new methods that are becoming increasingly available, resulting in better treatment outcomes. However, we still do not use all the possibilities for the prevention and treatment of these side effects, probably due to their insufficient research, or unclear effectiveness. Functional magnetic stimulation is a method used to treat a large number of diseases, i.e., to alleviate their symptoms and ailments. Its role through pelvic stimulation has been proven in the treatment of incontinence in women, and in our study, we want to determine its role in more detail, primarily in the treatment of urinary incontinence in patients after prostate cancer surgery. In case of positive results, this method may be recommended for wider use in patients with adverse effects of radical prostatectomy.
... Electromagnetic therapy non-invasively passes through neuromuscular tissues to depolarize nerve cells, thus changing the resting state membrane potential and reducing pain transmission [180].Meta-analysis results show that electromagnetic treatment of pelvic floor pain, with a frequency ranging from 1-50Hz, stimulates an increase in the blood flow of local tissues and improves the ischemic state of the tissues, with a frequency of 10Hz acting as a neural analgesic, and with a frequency of 50Hz it can achieve tissue decongestion, stimulate repair, from 1 time per day to 2 times per week, duration of 2-16 weeks, treatment ranging from 10min-24 hours, but mostly in the treatment of 20-30 minutes can play a satisfactory effect [136], but there are also clinical studies show that the use of different frequencies to treat pelvic floor pain, 2 times per week, for 4 consecutive weeks, 10Hz 15min, 50Hz 15min [181]. ...
Female pelvic floor dysfunction (FPFD) is a series of conditions caused by the displacement or dysfunction of the patient's pelvic organs due to defects, injuries, and deterioration of the pelvic floor supportive structures, with stress urinary incontinence and pelvic organ prolapse being the most common. The mechanism of pelvic floor dysfunction is complex and not yet fully understood, and is often related to one or more functional abnormalities of muscles, connective tissues, fascia, nerves and blood vessels. Specialized clinicians are often unable to cover the comprehensive medical professional information of various specialties such as gynecology and obstetrics, urology, anus and intestines, imaging, etc., and the systematic and comprehensive diagnosis and treatment of the disease will be limited. The application of artificial intelligence concepts in the medical field not only improves the diagnostic efficiency of physicians, but also provides reference and basis for the development of comprehensive treatment programs. This article follows and draws on the diagnosis and treatment process of pelvic floor dysfunction recommended in various guidelines, incorporates physical therapy techniques into the conventional non-surgical treatment of pelvic floor dysfunction, provides guidance for the diagnosis and treatment of pelvic floor dysfunction, and briefly introduces the clinical application and value of pelvic floor intelligent diagnosis and treatment in pelvic floor dysfunction.
... This could signify that the high quality of the randomized study could be attributed to several factors, such as the presence of a sham group, an estimation of the number of trials, the testing of a methodology with reliable outcome indicators, as well as long-term follow-up [24]. ...
Purpose:
The aim of this study is to identify and critically evaluate literature regarding the clinical efficacy of extracorporeal magnetic innervation (ExMI) in the treatment of female patients with urinary incontinence (UI).
Methods:
An analysis was carried out using the following electronic databases: Medline, PubMed, ScienceDirect, and the Cochrane Library (data published between 2008 and 2023). Searches of the above databases were conducted in April 2023. Only randomized clinical studies (RCTs) in English studies were eligible for the study. Randomized controlled trials were included in the review and evaluated with the Downs and Black checklist.
Results:
Eleven studies met the inclusion criteria. Among these, two studies examined the use of ExMI and PMFT (pelvic floor muscle training) and three studies compared active ExMI versus sham ExMI. Four studies evaluated solely ExMI, and moreover, there was no control group in two of these studies. One study compared the effects of Kegel exercises with ExMI, while another study compared electrostimulation with ExMI. The reviewed studies exhibited significant differences in interventions, populations, and outcome measures.
Conclusions:
Extracorporeal magnetic stimulation has shown promise as an effective treatment for female urinary incontinence. Whether used alone or as a component of combination therapy, ExMI has the potential to enhance patients' quality of life (QoL) without significant safety concerns.
... Считается, что ПМС подавляет ГАМП за счёт ингибирования рефлекса мочеиспускания. В ответ на наполнение мочевого пузыря повышенная активность уретрального сфинктера вызывает расслабление мышцы детрузора, так как афферентные ветви нервов мышц конечностей препятствуют мочеиспусканию во время реакции «бей или беги» [26]. ...
Introduction. Neuromodulation has proven itself in the treatment of patients suffering from idiopathic overactive bladder and non-obstructive urinary retention, who are resistant to conservative therapy. The possible use of the method in the population of patients with neurogenic lower urinary tract dysfunction (NLUTD) is of undoubted clinical interest.
Objective. To analyze the current possibilities and features of neuromodulation in a cohort of patients with NLUTD.
Materials and methods. Original research materials published in the PubMed, eLibrary, SciVerse (ScienceDirect), Scopus, Medline, EMBASE databases, websites of professional associations without restrictions on the date of publication were used. Sixty sources were selected for citation, with preference given to systematic reviews, meta-analyses and RCTs .
Results. In relation to NLUTD, transcranial and peripheral magnetic stimulation, intravesical electrical stimulation, tibial, pudendal electrical stimulation, and stimulation of the dorsal pudendal nerve, as well as sacral and epidural methods of neurostimulation are considered.
Conclusion. The current literature optimistically presents the experience of using neuromodulation in the NLUTD patient population with the largest evidence base for invasive sacral and tibial stimulation. The studies are based on heterogeneous populations, limited by small sample sizes with insufficient descriptive part of the degree and severity of neurological diseases, and it should be considered when forming guidelines. However, the lack of other suitable therapies and promising initial results indicate the importance of further efforts to improve the applied methods of neuromodulation. Further studies are needed with larger sample sizes, better classification of diseases, and controlled study design
... As the afferent branches of limb muscle nerves prevent voiding during fight-or-flight responses and afferent anorectal nerve branches prevent voiding during defecation, increased activity of the urethral sphincter induces relaxation of the detrusor muscle in response to bladder filling. The activity of the sympathetic nervous system also increases in response to bladder filling [23]. ...
Background
This study was conducted to determine the impact of a pulsed electromagnetic field (PEMF) on mixed incontinence. This condition can have a significant impact on women’s quality of life and social relationships.
Methods
Parous females (n = 40) with mixed incontinence were randomly assigned to one of two groups. Group A received PEMF and pelvic floor muscle training in addition to general advice for 12 sessions. Group B received the same program but without PEMF. Pelvic floor muscle strength and the severity of urinary incontinence were assessed using a perineometer and the incontinence symptom severity index (ISSI), respectively.
Results
Within groups comparison show statistically significant improvement in priniomter and severity index after treatment in comparison to pre treatment values. Between groups comparison after treatment showed better improvement in group A (p < 0.05) in pelvic floor muscle strength and a significant decrease (p < 0.05) in the severity of urinary incontinence compared to group B.
Conclusions
PEMF combined with pelvic floor muscle training is an effective, convenient, and acceptable way to manage mixed incontinence.
... Extracorporeal magnetic stimulation (EMS) is a non-invasive, effective, acceptable, and safe therapeutic modality for SUI [6,7]. In EMS, induction of a changing magnetic field results in a flow of electrons within the field, controlled depolarisation of the adjacent nerves, and subsequent muscular contraction [13]. Although the optimal frequency and duration of treatment are not yet established, findings of a systematic review have suggested that higher frequency and pulse duration provide an adequate modality for achieving treatment efficacy [14]. ...
Stress urinary incontinence (SUI) is defined as a complaint of inadvertent loss of urine occurring as a result
of an increase in intraabdominal pressure. Strong evidence supports the use of pelvic floor muscle training
(PFMT) as the first-line conservative treatment for SUI. Extracorporeal magnetic stimulation (EMS) is a noninvasive,
effective, acceptable, and safe therapeutic modality for SUI. Although PFMT and EMS share most of
their influences on the pathophysiology of SUI, it is unclear whether one of these routinely used treatment
modalities is superior to another in terms of improvement of clinical outcomes or cost-effectiveness. To the best
of our knowledge, no randomized controlled trials have so far directly compared PFMT with EMS. Our aim here
is to describe a protocol for such a study.
This will be a parallel-group, single-blind, randomised controlled trial compliant with the SPIRIT, CONSORT, and
TIDieR reporting guidelines. Participants will be women aged 18 to 65 years who have previously given at least
one vaginal delivery (at least 12 months before joining the study) who present with symptoms of SUI lasting at
least 6 months yet have not previously received treatment for it. In the first study arm, patients will receive an
eight-week, high-intensity, home-based Kegel exercises regimen. In the second study arm, the treatment scheme
will consist of 2 sessions of EMS per week for a total of eight weeks. The primary outcome will be effectiveness
of treatment as measured by the International Consultation on Incontinence Questionnaire Urinary Incontinence-
Short Form overall score, eight weeks, three months, and six months after commencement of treatment.
... Then, homologous muscle fibers depolarize and contract. 40,43 MS may modify the activity in pelvic floor muscle groups, as well as the discharge pattern and frequency of motor nerve fibers responsible for resting tension of the pelvic floor and sphincter. Moreover, MS is associated with a significant increase in bladder volume, which may be attributed to acute activation of the inhibitory detrusor reflex pathway after stimulation of the pudendal afferent nerve. ...
Aim:
This meta-analysis aimed to evaluate the efficacy of magnetic stimulation (MS) in treating female stress urinary incontinence (SUI) and providing an alternative treatment for patients who are unwilling to undergo surgery.
Methods:
Randomized controlled trials (RCTs) that evaluated MS as a remedy for female SUI were retrieved from various electronic databases, including MEDLINE, EMBASE, and the Cochrane Controlled Trial Registry system. Moreover, reference lists for related papers were carefully screened for relevant studies.
Results:
A total of six RCTs evaluating the effect of MS in treating female SUI were included in this study. Compared with the placebo group, the MS group exhibited higher quality-of-life scores [mean difference (MD) 0.59, 95% credibility interval (CI) 0.23-0.95; p = 0.001] and lower International Consultation on Incontinence Questionnaire scores (MD -3.93, 95% CI -5.85 to -2.01; p < 0.0001). Moreover, they exhibited a higher objective cure rate (odds ratio 8.49, 95% CI 3.08-23.37). In addition, MS treatment reduced the number of episodes of urinary incontinence (MD -1.42, 95% CI -2.24 to -0.59; p = 0.0007) and urine loss on pad test (MD -4.67, 95% CI -8.05 to -1.28; p = 0.007). There were no significant treatment-related adverse reactions.
Conclusion:
This study evaluated the efficacy and safety of MS in the treatment of female SUI. The results have important implications for patients who do not wish to undergo surgical therapy. We found that MS treatment for SUI has positive outcomes, however, future studies should aim at establishing the best protocol for optimizing the therapeutic effect.
... The key to the effectiveness of MS in the treatment of pelvic floor disorders is depolarization of nerve fibers, which leads to a gradual increase in strength and endurance of the PFM [95]. Due to the lack of an internal probe and the ability of the magnetic field to pass through clothing, MS is painless and well-tolerated by patients with pelvic floor dysfunction [94,96]. Nevertheless, this method has been verified in only a few studies, which makes it impossible to recognize it as an effective and recommended technique in the treatment of FI at present. ...
Fecal incontinence (FI) affects approximately 0.25-6% of the population, both men and women. The most common causes of FI are damage to/weakness of the anal sphincter muscle and/or pelvic floor muscles, as well as neurological changes in the central or peripheral nervous system. The purpose of this study is to report the results of a systematic review of the possibilities and effectiveness of physiotherapy techniques for the prevention and treatment of FI in women. For this purpose, the PubMed, Embase, and Web of Science databases were searched for 2000-2020. A total of 22 publications qualified for detailed analysis. The studies showed that biofeedback (BF), anal sphincter muscle exercises, pelvic floor muscle training (PFMT), and electrostimulation (ES) are effective in relieving FI symptoms, as reflected in the International Continence Society recommendations (BF: level A; PFMT and ES: level B). Research has confirmed that physiotherapy, by improving muscle strength, endurance, and anal sensation, is beneficial in the prevention of FI, both as an independent method of conservative treatment or in pre/post-surgery treatment. Moreover, it can significantly improve the quality of life of patients. In conclusion, physiotherapy (in particular, BF, PFMT, or ES, as effective methods) should be one of the key elements in the comprehensive therapy of patients with FI.
... This new form of conservative therapy for UI was approved by the United States Food and Drug Administration in 1998 10 . Pulsed magnetic fields are generated by an electrified coil that induces a flow of ions to form eddy currents when the excitable tissue is exposed to a magnetic field with a sufficient intensity 11 . Therefore, MS depolarizes the motor nerve to produce an action potential that ultimately triggers muscle contractions. ...
Magnetic stimulation (MS) is a novel approach for treating urinary incontinence (UI), but its applicability remains unclear. This systematic review and meta-analysis were conducted to evaluate the effects of MS treatment on UI. A literature search was performed in EMBASE, PubMed and Cochrane Library (from May 2018 to August 2018), and all randomized control trials (RCTs) published in English were screened to determine whether they met the inclusion criteria. A manual search of the reference lists of the retrieved studies was also performed. Eleven studies involving 612 patients were included in this review. According to the results of the meta-analysis, MS therapy relieved UI symptoms evaluated using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score (mean difference [MD] −3.03, 95% CI −3.27 to −2.79). In addition, the frequency of UI in the MS treatment group was also alleviated compared with sham group (MD −1.42, 95% CI −2.15 to −0.69). Finally, MS treatment improved the quality of life of patients with UI (standardized mean difference [SMD] −1.00, 95% CI −1.24 to −0.76). Our meta-analysis preliminarily indicates that MS treatment is an effective therapeutic modality for patients with UI. Nevertheless, additional large, high quality RCTs with a longer follow-up period that use consistent stimulation methods and analyse comparable outcomes are required to validate the efficacy.
... При клинически противоположных формах нейрогенных расстройств мочеиспускания во многих исследовательских работах наблюдался положительный терапевтический эффект сакральной МС, что может быть объяснено активацией различных регуляторных рефлексов в ответ на стимуляцию одних и тех же структур [48][49][50]. ...
Urinary disorders caused by peripheral nervous system injury are characterized by weakness of neural control of lower urinary tract. Clinical and urodynamic examination demonstrate detrusor-hyporeflexia and its reduced contractility. Magnetic stimulation influences autonomic and somatic nerves innervating pelvic organs but the mechanism of action is still unclear. This paper presents literature review on diagnostics and treatment of neurogenic urinary disorders by using magnetic stimulation and the results of our investigational study. 7 patients with neurogenic urinary retention were included in a prospective study of peripheral repetitive magnetic stimulation. Prolonged clinical improvement during the follow-up of 3 months was observed in all patients.
... 16 Voltage gradient ensues, and membrane depolarization occurs in the pelvic floor that leads to pelvic floor nerve stimulation (stimulation of motor end plates) and to pelvic floor muscle contraction. 32 Further, Galloway et al. 13 developed a pulsed magnetic device for pelvic floor muscle strengthening in the UI treatment and confirmed a significant reduction in the frequency of leakage episodes and detrusor instability. ...
Objective:
Urinary incontinence (UI) is one of the most common urinary system diseases that mostly affects women but also men. We evaluated the therapeutic efficacy of functional magnetic stimulation (FMS) as potential UI treatment with improvements in the pelvic floor musculature, urodynamic tests and quality of life.
Methods:
A total of 20 UI patients (10 females and 10 men, mean age 64, 14 years), including 10 with stress UI, four with urgency UI and six with mixed UI, were treated with FMS (20 min/session) twice a week for 3 weeks. The patients' impressions, records in urinary diaries, and scores of three life stress questionnaires (overactive bladder symptom questionnaire [OAB-q], urogenital distress inventory questionnaire-short form [UDI-6], incontinence impact questionnaire-short form [IIQ-7]) were performed pre- and post-treatment.
Results:
Significant reductions (P < 0.01) of micturition number and nocturia after magnetic treatment were evidenced. The urodynamic tests recorded a significant increase in cystometric capacity (147 ± 51.3%), in maximum urethral closure pressure (110 ± 34%), in urethral functional length (99.8 ± 51.8%), and in pressure transmission ratio (147 ± 51.3%) values compared with the baseline values.
Conclusions:
These preliminary findings suggest that FMS with Magneto STYM (twice weekly for 3 weeks) improves the UI and may be an effective treatment for this urogenital disease.
... In den Studien seien insgesamt die Eingangskriterien, die Inkontinenzschweregrade und die Behandlungsdauer zu variabel, um allgemeine Schlussfolgerungen zu ziehen. Unklar ist darüber hinaus, wie lange ein eventueller Therapieeff ekt anhält [ 37 ] . ...
The syndrome of overactive bladder (OAB) with the symptoms of frequency, urgency and nocturia is often seen. After the diagnosis has been made by careful exclusion of other conditions, there are different symptomatic treatment strategies available. These include drug treatment as well as minimally invasive local surgical treatments and treatments which intervene with the control of the bladder by modulating central nervous areas. Alternative methods such as acupuncture may help in individual cases; the placebo effect is high and there is a lack of controlled studies.
© Georg Thieme Verlag KG Stuttgart · New York.
... It is thus an attractive form of electrical therapy, being relatively painless, non-invasive and free from side effects. It is also convenient as magnetic fields pass through clothing (Quek, 2005). Fujishiro et al. (2002) reported that magnetic stimulation of the sacral roots for the treatment of urinary frequency and urge incontinence produced a useful improvement in symptoms. ...
Purpose:
Purpose of this study was to evaluate the long term efficacy of repetitive sacral root magnetic stimulation (rSMS) in patients with monosymptomatic nocturnal enuresis (MNE).
Methods:
Forty four patients were randomized to receive either sham or real repetitive sacral root magnetic stimulation (rSMS; 15 Hz with a total of 1500 pulses/session) for 10 sessions. Evaluation was performed before starting treatment, immediately after the 5th and 10th treatment session, and 1 month later, using frequency of enuresis/week, visual analogue scale (VAS) and quality of life as outcome measures. Resting and active motor thresholds of gastrocnemius muscles were measured before and after the end of sessions.
Results:
Both treatment and control groups were comparable for baseline measures of frequency of enuresis, and VAS. The mean number of wet nights/week was significantly reduced in patients who received real rSMS. This improvement was maintained 1 month after the end of treatment. Patients receiving real-rSMS also reported an improvement in VAS ratings and quality of life. A significant reduction of resting motor threshold was recorded after rSMS in the real group while no such changes were observed in the sham group.
Conclusion:
These findings suggest that rSMS has potential as an adjuvant treatment for MNE and deserves further study.
... 4 While there are no randomized studies comparing QoL outcomes following open versus RARP, data from a recent meta-analysis showed a statistically significant advantage for RARP compared to both open and laparoscopic approaches in terms of 12-month urinary continence recovery. 5 Electrical stimulation was first used to treat urinary incontinence in 1963 6 and is reportedly effective at treatments associated with female stress and urge incontinence. 7,8 Electrical stimulation performed better than control interventions for PPI patients in terms of less incontinence, continence reacquisition, and improved QoL during a 6-month period. ...
Objective: Postprostatectomy incontinence (PPI) is a major health problem that has substantial effects on health-related quality of life. In recent years, extracorporeal magnetic innervation (ExMI) has become a preferred treatment method for urinary incontinence. We evaluated the effects of ExMI on patients with PPI after robotic-assisted radical prostatectomy (RARP), specifically regarding health-related quality of life.
Materials and methods: From September to December 2014, patients with post-RARP PPI were enrolled in the study. A 20-minute ExMI treatment session was provided twice a week for two months. Number of voids, incontinence and urgency episodes, and mean and maximum voided volume per micturition (mL) were recorded in a 3-day bladder diary. Quality of life was assessed using the Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire (IIQ-7), and International Prostate Symptom Score quality-of-life questionnaire (IPSS-QoL). All assessments were conducted before and within 2 weeks after ExMI treatment. A favorable outcome was defined as an IPSS-QoL score 2-point decrease in the pretreatment score.
Results: Thirteen patients with a mean age of 69.3 years were enrolled. After ExMI, the number of incontinence episodes/3 d decreased to 5.85 from 9.15 (p = 0.004). The mean number of voids/d also decreased to 9.17 from 10.45 (p = 0.036). Patients' functional bladder capacity increased from 243.46 to 289.23 (p = 0.007). Scores of both UDI-6 and IPSS-QoL improved from 7.15 to 5.31 (p = 0.024) and 4.00 to 2.77 (p = 0.007). Patients aged
... 6 MS has been used to treat urinary incontinence in women. 7,8 Although promising preliminary clinical reports have been published, 9,10 contradictory clinical studies with opposing outcomes using central 11,12 and peripheral MS 13 treatments identified the need for investigations demonstrating if and how MS could support the cellular machinery of muscle and/or nerves to promote muscle training. 8 Nerve repair and prevention of posttraumatic muscle atrophy represent a major challenge in medical care. ...
Magnetic stimulation (MS) has the ability to induce muscle twitch and has long been proposed as a therapeutic modality for skeletal muscle diseases. However, the molecular mechanisms underlying its means of action have not been defined.
Muscle regeneration after trauma was studied in a standard muscle injury mouse model. The influence of MS on the formation of motor-units, post-trauma muscle/nerve regeneration, and vascularization was investigated.
We found that MS does not cause systemic or muscle damage but improves muscle regeneration by significantly minimizing the presence of inflammatory infiltrate and formation of scars after trauma. It avoids post-trauma muscle atrophy, induces muscle hypertrophy, and increases the metabolism and turnover of muscle. It triples the expression of muscle markers and significantly improves muscle functional recovery after trauma.
Our results indicate that MS supports muscle and nerve regeneration by activating muscle-nerve cross-talk and inducing the maturation of NMJs. This article is protected by copyright. All rights reserved.
© 2015 Wiley Periodicals, Inc.
... EMS might also change the pattern and rate of firing of the motor nerve fibers, which are responsible for the resting tone of the pelvic floor and sphincter muscles. 13 This new technology has been applied to pelvic floor therapy and treatment of SUI in clinical practice. 10,11,[14][15][16] There are some data showing that EMS of the sacral nerve roots may suppress detrusor overactivity and have a beneficial effect on women with SUI and OAB. ...
The aim of this study was to investigate the efficacy of extracorporeal magnetic stimulation (EMS) for the treatment of bothersome and severe symptoms of stress urinary incontinence (SUI) and overactive bladder syndrome (OAB) in female patients.
A retrospective review was conducted on patients with SUI and OAB who were referred to EMS therapy. Successful treatment for the bothersome symptoms of OAB and SUI was defined as score ≤1 for questions 2 and 3 on the Urodynamic Distress Inventory-6. The objective cure of SUI and OAB was defined as no urinary leakage during the cough stress test and any urgency, urge incontinence and voiding frequency of less than eight times per 24 h based on the 3-day bladder diary, after the 9 weeks of treatment, respectively.
Ninety-three patients with SUI or OAB underwent a 9-week course of EMS at 20 min twice weekly. Seventy-two (77%) patients completed EMS treatment. Geographical factor and poor economic status were two main factors for dropout. A total of 94.1% (32 of 34) and 86.8% (33 of 38) of subjects had successful treatment for the bothersome symptoms of OAB and SUI, respectively. In contrast, the cure rate for OAB and SUI was only 61.7% and 42.1%, respectively. There was also a significant improvement in both Urogenital Distress Inventory Short Form (bothersome on lower urinary tract symptoms) and the Incontinence Impact Questionnaire Short Form (quality of life) total score in both groups after EMS.
EMS is a safe and effective alternative method for treating SUI and OAB. Further studies are needed to evaluate the long-term efficacy.
... This lack of effect could be explained by the fact that there is a significant placebo effect in these forms of clinical trials because patients are closely monitored and they complete multiple voiding diaries, which is a form of bladder re-training. The device that we evaluated used frequencies and generated output similar to devices used in other studies, but we would agree with a recent review by Quek [24] that optimal stimulation parameters including intensity, frequency, duration and number of sessions needs to be established and standardised before other placebocontrolled trials are performed if this type of therapy is to gain acceptance as a treatment for voiding dysfunction. ...
Overactive bladder (OAB) is a prevalent condition with 16% of adults having one or more symptoms that significantly affect quality of life. Transcutaneous electrical nerve stimulation and neuromodulators have had success in treating OAB but are expensive, invasive, and sometimes cumbersome. We developed an alternative neuromodulatory technique that involves electromagnetic stimulation of the sacral nerve roots with a portable electromagnetic device to produce trans-sacral stimulation of the S3 and S4 sacral nerve roots. The aim of this study was to evaluate the impact of this device on OAB symptoms in women with a prospectively randomised double-blind controlled study. Following a power analysis, women with symptoms of OAB were prospectively recruited with ethical approval for randomisation to an active treatment (n = 33) or placebo group (n = 30) in a double-blind trial. The patient, at home, used the belt device daily for 20 min over 12 weeks. Outcome measures included a 3-day voiding diary, 1 h pad test, visual analogue score (VAS) for symptom impact (0-100%), Kings Health Questionnaire (KHQ) and Australian Quality of Life questionnaire (AQOL) at baseline, 6 and 12 weeks. Overall, no difference was found between groups for any of the research questions. Specifically, we were unable to demonstrate any difference between the active and sham device groups in frequency, nocturia, urinary leakage, or quality of life, nor was there any evidence of a placebo effect. The quality of the data was high with the number of missing observations (especially for disease specific KHQ and general AQOL) being few. This attempt to promote trans-sacral electromagnetic neuromodulation with a specially created device was ineffective on the symptoms of OAB.
Magnetic stimulation is a type of well-known method of magnetic therapy in physiotherapy practice. In contrast to electrical stimulation, in which afferent and efferent nerve fibers are directly excited, an alternating magnetic field causes an indirect secondary depolarization of the cell membrane due to the resulting potential difference. Magnetic stimulation for the purpose of correcting the dysfunction of the lower urinary tract symptoms has become widespread since the 90s of the XX century in the form of the method of extracorporeal magnetic stimulation and stimulation of the sacral roots S3 area. Magnetic stimulation of the pelvic floor and the area of the sacral roots is a promising method of rehabilitation with impaired lower urinary tract symptoms function and can be considered as one of the alternative safe measures in the treatment of this category of patients, which reduces the severity of symptoms. The effectiveness of this method is manifested mainly in irritative forms of disorders caused by the neurogenic and psychogenic nature of the lesion.
Introduction . Lower urinary tract symptoms (LUTS) are common in men and are associated with a significant decrease in quality of life. To date, there is no universal approach to the treatment of LUTS, which determines the need to search for new methods for influencing the lower urinary tract.
Purpose of the study . To test the hypothesis that the use of peripheral magnetic neuromodulation (PMN) in male patients with LUTS will reduce the severity of LUTS.
Materials and methods . Sixty-eight men with LUTS were enrolled in a prospective, randomized study. Patients were randomized in a 1:1 ratio for PMN or drug therapy with an alpha-1-blocker (tamsulosin). The primary endpoint was a reduction the LUTS severity such as urinary frequency during the day, nocturia and urgency as assessed using the IPSS questionnaire and urination diary. Improvements in urodynamic parameters such as maximum urine flow rate (Q max ), mean urine flow rate (Q ave ), and residual urine volume (PVR) were the secondary endpoint of the study. The results were evaluated on equal terms (10 days and 1 month) in both groups.
Results . Sixty-seven (98.5%) subjects were included in the final base. Ten days after the start of therapy in the magnetic stimulation group, symptom relief was noted by 21 people (61.7%), the mean IPSS score showed a decrease from 18.1 ± 2.1 to 16.9 ± 3.2 points (p = 0.037). The number of urinations per day decreased from 14 (6 - 20) to 10 (6 - 14) times (p < 0.001). Objective indicators of urodynamics did not change in both groups. At a period of 1 month, PMN occurred in 22 (64.7%) patients, the IPSS score was 16.6 ± 3.7 points (p = 0.032), the number of urinations 9 (6 - 14) times (p < 0.001). Objective indicators have not changed. In the tamsulosin group, IPSS score changed from 19.27 ± 5.08 to 15.4 ± 4.85 (p < 0.001), Q max 14.36 ± 2.82 ml/s increased to 15.94 ± 2.71 ml/s (p = 0.032), while the Q ave did not change (p = 0.17). The number of urinations decreased from 13 (6 - 19) times to 10 (6 - 14) times (p <0.001).
Conclusion . The study demonstrated the promise of PMN in men with LUTS in terms of improving the quality of life. The proposed method may be preferable for patients dissatisfied with drug therapy. Further placebo-controlled studies are required to help determine the role of PMN in the management of patients with LUTS.
Die International Continence Society (ICS) definiert Harninkontinenz als „jeden unfreiwilligen Urinverlust“. Damit wurde eine ältere Definition abgelöst, die eine Harninkontinenz nur dann als medizinische Diagnose akzeptierte, wenn die Menge des Urinverlusts ein soziales oder hygienisches Problem ausmachte. Die ICS gibt 5 separate Harninkontinenzformen vor [1]. Diese Reduktion auf eine Inkontinenzform mit monokausaler Ursache wird aber dem geriatrischen Patienten nicht gerecht. Hier ist Harninkontinenz als klassisches geriatrisches Syndrom mit vielen Querbezügen zur Multimorbidität, zur Multimedikation, zur Mobilität und Kognition zu verstehen. Deswegen bedarf es einer besonderen Betrachtung bzw. einer Erweiterung der diagnostischen und therapeutischen Maßnahmen. Dies gilt außerordentlich für routinemäßige urologische Standard-Therapien, die im Kontext eines geriatrischen Patienten spezifische Gefährdungspotentiale entfalten. Gemeint sind etwa ZNS-Nebenwirkungen bestimmter Anticholinergika, die hypertensive Wirkung von Mirabegron oder das floppy-iris-Syndrom und die Sturzneigung unter Tamsulosin.
Das Syndrom der überaktiven Harnblase (OAB) ist häufig. Voraussetzung für eine der nahezu ausnahmslos symptomatischen Ansätze einer Therapie ist eine gründliche Ausschlussdiagnostik. Neben einer medikamentösen Therapie kommen minimal-invasive operative Maßnahmen ebenso zum Einsatz wie Methoden, die durch Modulation zentralnervöser Zentren in die Steuerung der Harnblase eingreifen, aber auch alternative Methoden.
Aims
To evaluate the value of magnetic stimulation (MS) in patients with pelvic floor dysfunction (PFD).
Methods
The Preferred Reporting Items for Systematic Review and Meta‐analysis (PRISMA) statement was followed. We searched five databases for articles published until November 2017. Included studies investigated the effects of MS on PFD. Meta‐analysis of RCTs was performed using a random effects model, and narrative analysis was undertaken where meta‐analysis was not possible.
Results
A total of 20 studies including 1019 patients were eligible for inclusion whose level of evidence for the included studies was low. Meta‐analysis of four trials comparing MS with sham intervention showed that MS was not associated with significant improvement in ICIQ‐SF score (−0.52, 95%CI −1.05, 0.01; P = 0.06, I² = 16%), QOL score (−0.27, 95%CI −0.57, 0.04; P = 0.09, I² = 0%), number of leakages (−0.16, 95%CI −0.62, 0.29; P = 0.48, I² = 52%), and pad test (−1.36, 95%CI −2.64, −0.08; P = 0.04, I² = 94%). Narrative review showed that there were no convincing evidences that MS was effective for chronic pelvic floor pain, detrusor overactivity, overactive bladder, and the included RCTs had controversial results. MS may have some benefits for nocturnal enuresis and erectile dysfunction according to the trials.
Conclusions
There is no convinced evidence to support the benefits of using MS in the management of PFD. The applicability of MS in the treatment of PFD remains uncertain, so larger, well‐designed trials with longer follow‐up periods adopted relevant and comparable outcomes are needed to be further explored to provide a definitive conclusion.
Introduction and hypothesis:
We evaluated the effects of pulsed magnetic stimulation (PMS) on overall and different aspects of quality of life (QoL) in female patients with stress urinary incontinence (SUI).
Methods:
This study involved 120 female SUI subjects aged ≥21 years old randomized to either active or sham PMS. Treatment involved two PMS sessions per week for 2 months (16 sessions). After 2 months, subjects could opt for 16 additional sessions regardless of initial randomization. The primary response criterion was a 7-point reduction in the total score of the International Consultation on Incontinence Questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) questionnaire. Follow-ups were conducted at months 1, 2, 5, 8, and 14.
Results:
At 2 months, 35 out of 60 (58%) subjects in the active arm and 21 out of 60 (21%) in the sham arm were treatment responders (≥7-point reduction) (p = 0.006). There was a significant difference in changes in the mean ± SE ICIQ-LUTSqol total score between the active and sham arms (Mdiff = -8.74 ± 1.25 vs -4.10 ± 1.08, p = 0.006). At 1-year post-treatment, regardless of number of PMS sessions (16 or 32 sessions), subjects who received active PMS (63 out of 94, 67%) were more likely to be treatment responders compared with subjects who did not receive any active PMS (3 out of 12, 25%; p < 0.001). The impact of PMS treatment was the greatest on the "physical activities" domain.
Conclusions:
PMS resulted in significant short- and long-term improvements in overall and various physical, social, and psychological aspects of QoL.
Background: Extracorporeal magnetic innervation (ExMI) has been developed for the stimulation of pelvic floor muscles. It is a novel therapy for urinary incontinence. To date, there is only one report from abroad about the stimulation of pelvic floor muscles by ExMI for urinary incontinence following radical prostatectomy. Objective: To compare and analyze the treatment effect of ExMI and pelvic floor muscle exercise (PFME) on urinary incontinence after radical prostatectomy. Desgin, time and setting: The randomized controlled clinical trial was performed at the Department of Urology, Xijing Hospital of Fourth Military Medical University of Chinese PLA from February 2005 to February 2007. Participants: Twenty-four patients with urinary incontinence after radical prostatectomy were randomly assigned to ExMI group and PFME group (n =12). Methods: For ExMI group, the frequency of the pulse field was 10 Hz for 10 minutes, followed by a 3 minutes rest and a second treatment at 50 Hz for 20 minutes. The treatment lasted for 30 minutes every time and twice a week. The patients in PFME group were advised to do the exercise of anal contraction and relaxation, anal sphincter contraction similar to sudden interruption of urination by keeping abdominal muscle relaxation. The contraction was for 3 seconds each time followed by a 3-second rest, 20 minutes once, 3 times a day for successive 6 weeks. Main outcome measures: The therapeutic effect was evaluated by Quality-of-Life Scale and the International Continence Inquiring Committee Questionnaire Short Form (ICI-Q-SF). Results: Twenty-four patients were all included in final analysis. There were no significant differences in ICI-Q-SF scores between two groups before treatment. After one month of treatment, both scores for the Quality-of-Life Scale and ICI-Q-SF were decreased (P < 0.05-0.01), and there were no significant differences between two groups. After 3 months and 6 months of treatment, the scores of two scales continued to decrease, and those of ExMI group were significantly lower than those of PFME group (P < 0.05). No complications were noted in any of the groups. Conclusion: ExMI is superior over PFME in treating urinary incontinence after radical prostatectomy.
• Stress, urge (overactive bladder; OAB) and mixed incontinence is more prevalent in women than men, with prevalence of the stress type peaking in females in their 50s and OAB and of stress incontinence increasing with age • Age, Caucasian ethnicity, high BMI, smoking, alcohol intake, higher education, hormone status, comorbidities and medications are all associated with urinary incontinence • Association with caffeine is less strong than previously thought, however reduced fluid intake does reduce incontinence episodes in those consuming >1L/day • Weight loss is an important non-surgical treatment in moderately obese women • Supplemental magnesium may be beneficial OAB in women, while potassium may relieve symptoms of urinary incontinence and frequency • Hormone replacement may affect incontinence, with synthetic hormones worsening symptoms • There is considerable high-level evidence for mind-body interventions, such as relaxation, CBT, mediation, imagery, biofeedback and imagery • Moderate evidence supports bladder training • Magnetic stimulation is a new therapy for incontinence and evidence to date suggests it may be effective in the short term • Electrostimulation trials have had some inconsistently positive results • Pelvic-floor muscle training, the most effective and commonly recommended physical therapy for women, can be easily initiated but current guidelines recommend specialised training • Acupuncture has been trialled with some success for urinary incontinence.
Overactive bladder (OAB) treatment follows a well-defined and accepted stepped approach with lifestyle modifications, pelvic floor exercises, pharmacologic agents (anti-muscarinics, β3-agonists) and lastly more invasive interventions (botulinum toxin, neuromodulation, surgery) as necessary. When those standard options fail or cannot be applied to a specific patient, one can become familiar with various ancillary treatments that have been studied and proposed for management of OAB. Herein we will review the rationale and results to be expected from bladder training, acupuncture, naturopathic and herbal remedies, magnetic stimulation, catheters, and tissue engineering.
Objectives:
To synthethise evidence based results related to non surgical management for urinary incontinence in women.
Materials and methods:
Electronic search in Pubmed, Cinahl, Cochrane Library, National Library for Health.
Results:
There were 72 randomized control studies and 8 reviews from the Cochrane Library.
Conclusion:
Moderate to high levels of evidence suggest that pelvic muscle training and bladder training may resolve urinary incontinence in women. A weight loss program from obesity state improve urinary continence. The effects of electrical stimulation of pelvic floor, oestrogene therapy were inconstant or inhomogeneous. Duloxetine may improve continence and quality of life but it's range in therapeutic algorithm is still to be defined.
Der Ersatz von terminal beschädigten Organen bleibt ein grosses Problem der Medizin. Der Mangel an Spenderorganen und der mit Immunsuppressions-Therapie assoziierte Komorbiditäten führen daher zur Anwendung regenerativ-medizinischer und Gewebe- züchtender Methoden im Bereich des Organersatzes. Die Verwendung von autologen Zellen und azellulärer oder synthetischer Polymere in der Rekonstruktion von Organen können helfen diese Probleme zu lösen und Patienten mit Ersatzorganen aus körpereigenen Zellen zu versorgen. Muskelstammzellen dienen die Muskelregeneration und sind deshalb eine vielversprechende Quelle für Zellmaterial. Diese Zellen beinhalten die Fähigkeit Muskelfasern zu regenerieren und wurden im Zusammenhang mit der Behandlung verschiedener Muskelkrankheiten bereits untersucht. In der Urologie eröffnen Muskelstammzellen neue Behandlungsmöglichkeiten zur Rekonstruktion von Harnblasenmuskeln, in der Behandlung sexueller Dysfunktionen und in der Behandlung von Urininkontinenzen. Urininkontinenz ist ein verbreitetes Krankheitsbild in älteren Patienten und wird gemäss der International Continence Society definiert als der unwillentliche Verlust von Urin, der zu sozialen oder hygienischen Problemen führen kann. Das Krankheitsbild betriff etwa 50% der weiblichen Population über 45 Jahren und betrifft 17% aller Männer älter als 70 Jahre. Urininkontinenz ist dennoch eine der häufigsten Komplikationen nach der Standardbehandlung für lokalisierte Prostatakarzinome und betrifft zwischen 8% und 77% der männlichen Patienten. Bevor Muskelstammzelltherapien beim Menschen angewandt werden können, müssen Funktion, Sicherheit und Interaktionen der Stammzellen nach der Implantation noch verbessert werden. Patienten, die auf gezüchtete Gewebe angewiesen sind und ihre Organe sind oft älter und haben daher ein höheres Krebsrisiko. Es war in diesem Zusammenhang bislang unbekannt, ob sich das Verhalten von Muskelstammzellen in Gegenwart von Tumoren ändert oder ob die Implantation von Muskelstammzellen in die Nähe malignen Gewebes Tumorproliferation oder Metastasenbildung begünstigt. Ausserdem müssen Alter und Geschlecht des Donors mitberücksichtigt werden um eine dem Patienten gerechte Stammzelltherapie anbieten zu können. Ferner ist es notwendig, nach der Transplantation die weitere Zellentwicklung zu verfolgen um einen konsistenten und anhaltenden Behandlungserfolg zu erzielen. In dieser Dissertation zeigen wir, dass Muskelstammzellen generell sicher sind bei der Muskelregeneration bei Patienten die zuvor an Karzinomen litten. Muskelstammzellen verhindern ein erneutes Auftreten von Karzinomen indem sie parakrines TNFα sekretieren und das Tumorwachstum inhibieren. Solche Muskelstammzellen können von Patienten beiderlei Geschlechts und aller Altersgruppen isoliert werden und tragen bei, neues Muskelgewebe mit sich verbessernder Funktion zu bilden. Das hohe Wachstumspotential von Muskelstammzellen und ihre Funktionalität erlauben die Transplantation hinreichend vieler Zellen schon 3 Wochen nach der Muskelbiopsie. Zusätzlich kann die Zellintegration und Muskelregeneration nach der Muskelstammzellimplantation durch magnetische Stimulation angeregt werden, die das Einwachsen von Nerven und die Ausbildung Neuromuskulärer Junctions begünstigt. Diese nicht-invasive und durch die FDA anerkannte Behandlungsmethode kann also benutzt werden um die Bildung von Muskelfasern und die Gewebeintegration zu verbessern SUMMARY The replacement of terminally damaged organs remains a major problem in healthcare. The shortage of available donor organs and the high morbidity of immunosuppressive therapy lead to the application of regenerative medicine and tissue engineering to the field of organ replacement. The use of autologous cells and acellular or synthetic polymers for organ reconstruction has the potential to overcome these shortcomings and provide replacement organs made from patients own cells. Muscle Precursor Cells (MPCs), for muscle regeneration, are envisioned as promising cell sources with the capability to regenerate muscle fibers, and therefore investigated for the treatment of several muscular diseases. In Urology, it opens novel treatment possibilities including reconstruction of bladder muscles, management of sexual dysfunction and treatment of Urinary Incontinence. Urinary Incontinence is a common condition in the elderly defined by the International Continence Society (ICS) as an involuntary loss of urine leading to social or hygienic problems1. It affects around half of the female population2 over 45 years and 17% of men after 70 years3. In men, urinary incontinence is additionally one of the most frequent complications of the standard therapy to localized prostate carcinoma, with incidence ranging between 8 to 77%4. MPCs safety and interactions need to be investigated and its function after implant needs to be improved previous to human application. Patients in need of engineered tissues and organs are older and therefore exposed or at risk of cancers. However, it was hitherto unknown whether the behavior of MPC changes on the presence of tumor or if implanting MPC in the proximity of malignant tissues may induce tumor proliferation and metastasis. Likewise, age and gender of donor and recipient need to be taken into consideration to develop a cell therapy that reaches the specific patient needs. Moreover, a cell follow-up after transplantation is necessary to ensure a consistent and long- lasting therapeutic benefit. In this thesis when report that MPCs provide an overall safe muscle regeneration even for patients with previous cancer. They prevent cancer recrudescence by secreting paracrine TNFα and inhibiting tumor growth. Also, these cells can be isolated from patients of all ages and both sex, forming new muscle tissue with time progressing function. The growth potential of MPCs and function output after transplantation permits autologous transplantation of sufficient cell numbers 3 weeks after muscle biopsy. Additionally, magnetic stimulation supports cell integration and muscle regeneration after MPC implantation, promotes nerve ingrowth and the development of organized neuromuscular junctions. This non-invasive FDA approved treatment modality can be used to further improve muscle fiber formation and tissue integration.
Pressure ulcers are among the most common secondary injuries following spinal cord injury (SCI). A general consensus is that an effective prevention program would greatly reduce the incidence and prevalence of pressure ulcers. Increased risks for pressure ulcers following SCI are related to immobility, neurological impairments, and changes to biomechanical and microvascular properties of the soft tissue. Programs to minimize these risk factors might include technology to quantitatively assess tissue viability and management of tissue loading.
Objective:
To evaluate the effects of sacral magnetic stimulation (SMS) on functional and urodynamic improvement in patients with refractory stress urinary incontinence (SUI).
Design:
A sham-controlled, double-blind, parallel study design with a 4.5-month follow-up.
Setting:
A tertiary hospital.
Participants:
Women (age, 45-75y) with SUI refractory to first-line management (N=34) were allocated to either an experimental (n=20) group or a sham (n=14) group.
Interventions:
The SMS protocol consisted of 5-Hz, 20-minute treatments administered over the bilateral third sacral roots, with the intensity set at approximately 70% of the maximal output, for 12 consecutive weekdays.
Main outcome measures:
Urodynamic assessments and 2 life stress questionnaires, namely, the Urge-Urinary Distress Inventory (U-UDI) and the Overactive Bladder Questionnaire (OAB-q), were administered pre- and post-SMS intervention. We administered the U-UDI (primary outcome measure) and the OAB-q at 3-week intervals during the follow-up period until 18 weeks after the final intervention.
Results:
The experimental group exhibited significant improvements in both U-UDI and OAB-q scores postintervention (P=.011-.014) and at follow-up visits (P<.001-.007) compared with the sham group. In addition, significant increases in bladder capacity, urethral functional length, and the pressure transmission ratio (P=.009-.033) were noted postintervention. Multivariate regression analysis revealed that patients with more severe symptoms benefited more from SMS. A poorer baseline U-UDI score and a shorter urethral functional length were associated with a greater response to SMS.
Conclusions:
Our observations of a greater response to SMS in patients with more severe SUI than in those with mild symptoms, as well as the long-term benefits of the treatment, confirm the efficacy of SMS in treating SUI.
Seit 2001 wird in Deutschland eine neue Form der konservativen Therapie der Belastungs- und Dranginkontinenz, die Magnetstimulationstherapie, als Alternative zur herkömmlichen Elektrostimulationstherapie angeboten. Ergebnisse einer Magnetstimulationstherapie von 83 Patienten bei verschiedenen Indikation [Belastungsinkontinenz, Syndrom der überaktiven Blase (OAB) und Patienten mit chronischen Blasenschmerzen (pelvic pain syndrom, PPS)] werden vorgestellt. Die Erfolgsraten dieser konservativen nahezu nebenwirkungs- und schmerzfreien Therapie sind abhängig von der Indikation. 74% aller Patienten mit Belastungsinkontinenz lernten eine suffiziente Beckenbodenanspannung, 54% mit OAB-Symptomen verbesserten sich nach subjektiven und objektiven Kriterien, aber nur 23% von Patienten mit PPS gaben eine Verbesserung ihrer Symptome an. Dabei zeigten sich keine signifikanten Unterschiede zwischen Patienten >65 Jahren und jüngeren Patienten.
Urinary incontinence is a common and under-reported symptom, affecting one in five people, with a higher prevalence in women and those who are elderly. It can have a major impact on physical health and social activity. Initial assessment to categorize symptom type is the key to guiding further therapy. Non-pharmacological (NP) options are preferred as first-line intervention, and if unsuccessful, are followed by anticholinergics, often in combination with NP options. Surgical intervention must be sought where appropriate. However, NP interventions are often not considered due to uncertainty about the evidence-base, perceived difficulty of application and perhaps a lack of awareness of or access to specialist continence services. This article addresses the first of the barriers, summarizing the evidence for various NP interventions, including lifestyle interventions, physical therapies, behavioural therapies and containment options, enabling the reader to formulate an evidence-based opinion and a pragmatic view on the feasibility, efficacy and applicability of the various NP interventions, without automatic recourse to anticholinergic medication in the first instance.
Objectives
To synthetize evidence-based results related to nonsurgical management for urinary incontinence in women.
Materials and methods
Electronic search in Pubmed, Cinahl, Cochrane Library, and National Library for Health.
Results
There were 72 randomized control studies and eight review from the Cochrane Library.
Conclusion
Moderate to high levels of evidence suggest that weight loss from obesity state, pelvic muscle training, and bladder training may resolve urinary incontinence in women. The effects of electrical stimulation of pelvic floor, oestrogene therapy were inconstant or inhomogeneous. Duloxetine may improve continence and quality of life, but its range in therapeutic algorithm is still to be defined.
The purpose of this study was to prospectively evaluate symptom change after discontinuation of extracorporeal magnetic stimulation (EMS) in women with overactive bladder (OAB). A total of 48 women with OAB were included. We applied 10 Hz of repetitive magnetic stimulation with a "magnetic chair" for 20 min, twice weekly for 8 weeks. Changes in OAB symptoms at 2, 12, and 24 weeks after discontinuing the EMS were evaluated. Twenty-seven (56.3%) patients were cured compared with the baseline at 2 weeks: the cure rate was determined as 68.8% (33/48 patients), 56.3% (27/48), and 50% (8/16) for urgency, frequency, and urge incontinence, respectively. The mean number of voids per 24 h was decreased by 42.8% (from 14.5 +/- 4.3, to 8.3 +/- 1.5, P < 0.001) at 2 weeks after treatment. Maximum voided volume did not change significantly, but the mean voided volume increased significantly after stimulation. Twenty-six (96.3%) patients among the 27 patients who achieved a cure at 2 weeks, maintained improvement at 24 weeks; the therapeutic effect on urgency, frequency, and urge incontinence persisted in 26 (78.8%) of 33 patients, 26 (96.3%) of 27 patients, and six (75%) of eight patients, respectively. There were no significant changes in urodynamic parameters. Of the 14 patients with detrusor overactivity, the condition was no longer observed in four (28.6%) patients. EMS has a beneficial effect on women with OAB. Our data suggest EMS may have a significant carry-over effect in well-selected OAB patients.
Since 2001 magnetic stimulation therapy has been available in Germany for treating urinary incontinence as an alternative to traditional electrical stimulation therapy. The results of 83 patients who underwent magnetic stimulation therapy for stress incontinence, OAB, and pelvic pain syndrome were evaluated. The results differed depending on the underlying disease. Patients with stress incontinence who could not properly contract pelvic floor muscles before could do so in 74% when clinically evaluated and patients with OAB symptoms improved in 54% as assessed by objective and subjective criteria, whereas patients with pelvic pain syndrome only benefited in 23%. Comparison of the results according to age revealed no significant difference between patients >65 years and younger patients.
We evaluated the therapeutic efficacy of continuous magnetic stimulation on urinary incontinence by studying the urodynamic effect on urethral closure and bladder inhibition.
A total of 11 patients with stress incontinence and 12 with urge incontinence (7 males and 16 females, mean age 55.8 years) were evaluated. In the pilot study urethral pressure profile was performed before and after 20 Hz. 15-minute (with 1-minute on/30-second off cycles) stimulation, and maximum intraurethral pressure was recorded during stimulation in stress incontinence cases. Cystometry was performed before and during 15-minute stimulation at 10 Hz. in urge incontinence cases. In the therapeutic study 8 females with stress incontinence, and 3 males and 5 females with urge incontinence were treated with magnetic stimulation twice a week for 5 weeks.
In the pilot study maximum intraurethral pressure increased by 34% during stimulation and maximum urethral closure pressure increased by 20.9% (p = 0.0409) after stimulation in stress incontinence cases. In urge incontinence cases significant increases in bladder capacities at first and maximum desire to void during stimulation were noted (p = 0.0164 and 0.0208, respectively). In the therapeutic study 86% of 7 patients with stress incontinence and 75% of 8 with urge incontinence were improved, and 1 dropped out of the study.
Continuous magnetic stimulation was effective on urethral closure and bladder inhibition, and as treatment of urinary incontinence.
To perform a randomized comparative study investigating the urodynamic effects of functional magnetic stimulation (FMS) and functional electrical stimulation (FES) on the inhibition of detrusor overactivity.
Thirty-two patients with urinary incontinence due to detrusor overactivity (15 men, 17 women; age 62. 3 +/- 16.6 years) were randomly assigned to two treatment groups (15 patients in the FMS group and 17 in the FES group). Stimulation was applied continuously at 10 Hz in both groups. For FMS, the magnetic stimulator unit was set on an armchair type seat and had a concave-shaped coil, so that the patients could sit during stimulation. For FES, a vaginal electrode was used in the women and a surface electrode on the dorsal part of the penis was used in the men. Cystometry was performed before and during the stimulation.
The bladder capacity at the first desire to void and the maximum cystometric capacity increased significantly during stimulation compared with prestimulation levels in both groups (P = 0.0054 and 0.0026, respectively, in the FMS group and P = 0.0015 and 0.0229, respectively, in the FES group). However, the increase in the maximum cystometric capacity was significantly (P = 0.0135) greater in the FMS group (114.2 +/- 124.1 mL or an increase of 105. 5% +/- 130.4% compared with the pretreatment level) than that in the FES group (32.3 +/- 56.6 mL or an increase of 16.3% +/- 33.9%). Detrusor overactivity was abolished in 3 patients in the FMS group but not in any patient in the FES group.
Although both treatments were effective, the inhibition of detrusor overactivity appeared greater in the FMS group than in the FES group.
Urinary incontinence is a common health problem among women that negatively impacts quality of life. Therefore, it is important that primary care physicians have an understanding of how to manage urinary incontinence effectively.
To review the most recent, high-quality evidence regarding the etiology and management of urinary incontinence in women.
Searches of MEDLINE, EMBASE, The Cochrane Library, and the ACP Journal Club were performed to identify English-language articles published between 1998-2003 that focused on the etiology or treatment of urinary incontinence in adult women. The references of each retrieved article were reviewed and an expert in the field was contacted to identify additional relevant articles.
Using a combination of more than 80 search terms, we included articles of etiology that were cohort studies, case-control studies, cross-sectional studies, or systematic reviews of cohort, case-control, and/or cross-sectional studies. Studies of treatment had to be randomized controlled trials or systematic reviews of randomized controlled trials. The quality of each article was assessed independently by each author and inclusion (n = 66) was determined by consensus.
Multiple factors have been found to be associated with urinary incontinence, some of which are amenable to modification. Factors associated with incontinence include age, white race, higher educational attainment, pregnancy-related factors, gynecological factors, urological and gastrointestinal tract factors, comorbid diseases, higher body mass index, medications, smoking, caffeine, and functional impairment. There are several effective nonpharmacological treatments including pelvic floor muscle training, electrical stimulation, bladder training, and prompted voiding. Anticholinergic drugs are effective in the treatment of urge urinary incontinence. Several surgical interventions are effective in the management of stress incontinence, including open retropubic colposuspension and suburethral sling procedure.
Urinary incontinence in women is an important public health concern, and effective treatment options exist.
Objectives:
To report the first data from a prospective clinical study to determine the feasibility of using extracorporeal magnetic innervation (ExMI) for the treatment of stress urinary incontinence.
Methods:
We studied 83 women with demonstrable stress urinary incontinence. Treatments were for 20 minutes, twice a week for 6 weeks. For treatment, the patient sits fully clothed on a special chair; within the seat is a magnetic field generator that produces the rapidly changing magnetic field flux. Objective measures included bladder diaries, dynamic pad weight testing, urodynamic studies, and quality of life survey.
Results:
Fifty patients have been followed up for longer than 3 months (33 patients for less than 3 months); 17 patients (34%) were dry, 16 (32%) were using not more than 1 pad per day, and 17 (34%) were using more than 1 pad per day. Pad use was reduced from 2.5 to 1.3 (P = 0.001) and leak episodes per day were reduced from 3.3 to 1.7 (P = 0.001). The pad weight was reduced from 20 to 15 g. Detrusor instability was found in 5 patients before but was demonstrated in only 1 patient after treatment.
Conclusions:
ExMI therapy offers a new effective modality for pelvic floor muscle stimulation. ExMI is painless, there is no need for a probe, and no need to undress for treatments. Longer follow-up is required to determine how long the benefits of treatment last and whether retreatment will be necessary.
Objective:
To investigate the acute effects of functional magnetic stimulation (FMS) on detrusor hyper-reflexia using a multi-pulse magnetic stimulator.
Patients and methods:
Seven male patients with established and intractable detrusor hyper-reflexia following spinal cord injury were studied. No patient was on medication and none had had previous surgery for detrusor hyper-reflexia. After optimization of magnetic stimulation of S2-S4 sacral anterior roots by recording toe flexor electromyograms, unstable detrusor activity was provoked during cystometry by rapid infusion of fluid into the bladder. The provocation test produced consistent and predictable detrusor hyper-reflexia. On some provocations, supramaximal FMS at 20 pulses/s for 5 s was applied at detrusor pressures which were > 15 cmH2O.
Results:
Following FMS there was an obvious acute suppression of detrusor hyper-reflexia. There was a profound reduction in detrusor contraction, as assessed by the area under the curves of detrusor pressure with time.
Conclusions:
Functional magnetic stimulation applied over the sacrum can profoundly suppress detrusor hyper-reflexia in man. It may provide a non-invasive method of assessing patients for implantable electrical neuromodulation devices and as a therapeutic option in its own right.
Objective To investigate the acute effects of functional magnetic stimulation (FMS) on detrusor hyper-reflexia using a multi-pulse magnetic stimulator.
Patients and methods Seven male patients with established and intractable detrusor hyper-reflexia following spinal cord injury were studied. No patient was on medication and none had had previous surgery for detrusor hyper-reflexia. After optimization of magnetic stimulation of S2–S4 sacral anterior roots by recording toe flexor electromyograms, unstable detrusor activity was provoked during cystometry by rapid infusion of fluid into the bladder. The provocation test produced consistent and predictable detrusor hyper-reflexia. On some provocations, supramaximal FMS at 20 pulses/s for 5 s was applied at detrusor pressures which were >15 cmH20.
Results Following FMS there was an obvious acute suppression of detrusor hyper-reflexia. There was a profound reduction in detrusor contraction, as assessed by the area under the curves of detrusor pressure with time.
Conclusions Functional magnetic stimulation applied over the sacrum can profoundly suppress detrusor hyper-reflexia in man. It may provide a non-invasive method of assessing patients for implantable electrical neuromodulation devices and as a therapeutic option in its own right.
OBJECTIVE
To evaluate, in a prospective study, the efficiency and applicability of functional magnetic stimulation (FMS) of the pelvic floor for treating urinary incontinence in women.PATIENTS AND METHODSFMS was provided by a ‘magnetic chair’; 24 patients were treated twice weekly for 8 weeks (12 with urge incontinence and 12 with a mixture of urge and stress incontinence). The outcome was assessed urodynamically, by a pad test, and by patient satisfaction.RESULTSIn 58% of the patients there was an objective improvement in incontinence; three patients were completely dry and 71% reported a subjective improvement (P < 0.001).CONCLUSIONFMS is a safe, noninvasive and painless treatment for urinary incontinence; it is effective and easy to administer as an outpatient treatment.
Appropriate management of patients with urinary incontinence requires access to a variety of methods. Electrical stimulation, although so far proportionally small in the armamentarium of methods, is founded on physiologic principles and has the advantage of being curative without significant side effects.
Intravaginal electrical stimulation (IVS) induces a profound bladder inhibition and is successful in the treatment of incontinence due to detrusor instability. In this experimental study in cats, direct recordings of the efferent activity in thin hypogastric and pelvic nerve filaments to the bladder were used to analyze the neuronal mechanisms underlying this bladder inhibition. A longlasting reflex discharge, with a latency of 35 to 50 msec., was evoked in the hypogastric nerve by IVS. The reflex discharge was unaffected by imposed changes in intravesical pressure or by micturition contractions, but the response was very frequency-sensitive with an optimal transmission at about 5 Hz of stimulation. A "spontaneous" efferent activity could be recorded in the pelvic nerve filaments when the bladder pressure was elevated above 5 to 7 cm. H2O. The pelvic activity occurred in 10 to 20-second bursts, each followed by an abortive detrusor contraction. IVS of 5 to 10 Hz completely abolished this efferent pelvic activity by central inhibition. The findings are discussed in relation to the normal neuronal control of the bladder and to the clinical application of IVS.
To assess the effect of magnetic stimulation of the S3 nerve root on unstable contractions in patients with idiopathic detrusor instability.
Twelve patients with idiopathic instability were studied. The S3 nerve root was localized by mapping the response of the toe flexor muscles and anal sphincter to magnetic stimulation at different sites. Unstable contractions were provoked by rapidly infusing saline into the bladder and the effect of magnetic stimulation of S3 on contractions was assessed.
Magnetic stimulation relieved the sensation of urinary urgency and reduced the duration and amplitude of provoked contractions in all patients. Stimulation reduced the area under the pressure/time curve by 80-98%. In some patients there was a shortlived residual suppressive effect lasting up to 90 s.
Magnetic stimulation of S3 acutely abolishes unstable contractions in patients with idiopathic detrusor instability.
To report the first data from a prospective clinical study to determine the feasibility of using extracorporeal magnetic innervation (ExMI) for the treatment of stress urinary incontinence.
We studied 83 women with demonstrable stress urinary incontinence. Treatments were for 20 minutes, twice a week for 6 weeks. For treatment, the patient sits fully clothed on a special chair; within the seat is a magnetic field generator that produces the rapidly changing magnetic field flux. Objective measures included bladder diaries, dynamic pad weight testing, urodynamic studies, and quality of life survey.
Fifty patients have been followed up for longer than 3 months (33 patients for less than 3 months); 17 patients (34%) were dry, 16 (32%) were using not more than 1 pad per day, and 17 (34%) were using more than 1 pad per day. Pad use was reduced from 2.5 to 1.3 (P = 0.001) and leak episodes per day were reduced from 3.3 to 1.7 (P = 0.001). The pad weight was reduced from 20 to 15 g. Detrusor instability was found in 5 patients before but was demonstrated in only 1 patient after treatment.
ExMI therapy offers a new effective modality for pelvic floor muscle stimulation. ExMI is painless, there is no need for a probe, and no need to undress for treatments. Longer follow-up is required to determine how long the benefits of treatment last and whether retreatment will be necessary.
To study urodynamically the effect of functional continuous magnetic stimulation on urethral closure in normal volunteers.
Ten volunteers (6 men and 4 women, 20 to 29 years old, mean age 24.5) were recruited for the study. Seven subjects were assigned to an active group and 3 to a sham group. An 8F transducer was inserted transurethrally, and the urethral pressure profile was monitored. Then the catheter was fixed so that the transducer could be positioned at the portion at which the highest pressure was recorded (maximum intraurethral pressure). In the active group, the stimulating intensity was gradually increased up to the tolerable limit. A 15-minute single session of stimulation was carried out at 20 Hz in an intermittent manner with 1-minute-on/30-second-off cycles. After stimulation, the urethral pressure profile was repeated.
In the active group, the greatest pressure difference between the on and off phases of the maximum intraurethral pressure was 62.4+/-37.6 cm H2O at 35% to 55% of maximum output (46 to 113 J). In the urethral pressure profile, the maximum urethral closure pressure increased significantly after stimulation (P = 0.0280). In the sham group, no changes in these parameters were noted. All subjects tolerated the functional continuous magnetic stimulation well, and none experienced any adverse effect.
Functional continuous magnetic stimulation safely and significantly increased maximum intraurethral pressure during stimulation and maximum urethral closure pressure after stimulation.
To determine whether sacral root neuro-modulation (a promising therapeutic modality in patients with refractory voiding and storage problems) has its effect through the blockade of C-afferent fibres that form the afferent limb of a pathological reflex arc responsible for the dysfunction of bladder storage.
The study comprised 39 female Sprague Dawley rats divided into three equal groups: normal controls (group 1); spinally transected at T10 (group 2); spinally transected and electrically stimulated bilaterally at S1 for 6 h daily (group 3). Three weeks after transection the rats were assessed using urodynamics; substance P, neurokinin A and calcitonin gene-related peptide (CGRP) were extracted from the dorsal root ganglia (DRG) of the L5 and L6 roots and quantified by radioimmunoassay.
Spinally transected rats developed urinary bladder hyper-reflexia after 3 weeks. This was associated with a significant increase in the neuropeptide content of the DRG of L6. Electrostimulation of S1 significantly decreased the neuropeptide content of L6. In contrast, transection and S1 neurostimulation did not affect the neuropeptide content of the L5 DRG, except for CGRP, which increased after spinal transection and decreased with neurostimulation.
In spinally transected rats, sacral root neurostimulation abolished bladder hyper-reflexia and attenuated the rise in neuropeptide content of the L6 DRG. These results suggest that the blockade of C-afferent fibre activity is one of the mechanisms of action of sacral root neuromodulation.
Neuromodulation of the sacral nerve roots is effective to treat various voiding dysfunctions, but the underlying mechanism of neuromodulation is not known. The objective of this study is to evaluate whether inhibition of afferent c-fiber activity is the underlying mechanism of sacral nerve root neuromodulation.
Twenty-nine female Sprague-Dawley rats weighing 220 to 250 gm. were divided into 4 groups: normal control (normal rats without any procedure; n = 5), sham with saline (spinalized rats at T9 with saline bladder instillation; n = 7), sham with acetic acid (spinalized rats at T9 with acetic acid bladder instillation; n = 8) and stimulation group (spinalized rats at T9 with acetic acid bladder instillation plus electrical stimulation; n = 9). A cystometrogram was performed 10 days after spinal cord transection to confirm the development of bladder hyperreflexia. Bilateral electrode wires were implanted into S1 dorsal foramina and electrical stimulation was performed 8 hours a day for three weeks. The rats were perfused with 4% paraformaldehyde and an immunocytochemical method was used to stain fos-protein that was encoded by c-fos gene. A double-blind method was used in counting fos-protein positive neurons.
Bladder hyperreflexia developed in all spinalized rats 10 days after spinal cord transection. Peak bladder pressure was found significantly reduced after neuromodulation (30.4 +/- 4.2 cm. water) compared with the same rats before neuromodulation (82.4 +/- 10.2 cm. water; p = 0. 007). The number of fos-protein positive neurons in the L6 spinal cord segment in the neuromodulation group (93.2 +/- 13.3 cells/section) decreased significantly when compared with the sham with acetic acid group (160.6 +/- 25.0 cells/section; p = 0.02). There was no significant difference in c-fos expression between the sham with saline group (90.5 +/- 15.6 cells/section) and the neuromodulation group (p = 0.92).
Sacral dorsal root neuromodulation reduces c-fos gene expression and bladder hyperreflexia in spinalized rats, through inhibition of afferent c-fiber activity.
We designed an investigational study and placebo controlled trial to evaluate the potential efficacy of magnetic stimulation of the sacral roots for the treatment of stress incontinence.
A total of 75 patients with stress incontinence were studied. A 15 Hz. repetitive magnetic stimulation of the sacral roots with 50% intensity output and duration of 5 seconds per minute was applied for 30 minutes. Urodynamic investigations under magnetic stimulation were performed in 13 patients to evaluate acute effects to lower urinary tract function. There were 62 women (mean age 58 years) enrolled in a placebo controlled study to investigate the short-term efficacy of magnetic stimulation. The number of leaks for 3 days, amount of urine loss on a pad test and quality of life score were evaluated before and 1 week after stimulation.
The urodynamic investigations revealed an apparent elevation of urethral closure pressure induced by stimulation (mean 8.2 +/- 3.0 cm H2O, p = 0.0000004) and a significant increase in bladder capacity after stimulation (mean 40.0 +/- 51.0 ml., p = 0.0152). In the placebo controlled study the number of leaks and amount of urine loss on a pad test significantly decreased more in the active than in the sham stimulation group (p = 0.0023 and 0.0377, respectively). The quality of life score significantly improved in the active stimulation group (p = 0.0006) in contrast to no significant improvement in the sham stimulation group. The improvement rate in the active stimulation group was 74%, which was significantly higher than the 32% in the sham stimulation group (p = 0.0009). No adverse effects were noted in any patients.
These results suggest that magnetic stimulation of the sacral roots may be useful for the treatment of stress incontinence. Further studies are needed to evaluate the long-term efficacy of this potential treatment.
Pulsed magnetic technology has been developed for pelvic floor muscle strengthening for the treatment of urinary incontinence. This report includes an update of the prospective multicenter study of extracorporeal magnetic innervation (ExMI) therapy for stress incontinence and a discussion of the possible mechanisms of action. Issues of patient selection for ExMI therapy will also be discussed. One hundred and eleven women with demonstrable stress urinary incontinence were studied. The mean age was 55 +/- 13 years, and the mean duration of symptoms was 11 years. Ninety-seven completed ExMI therapy and analysis. Evaluation before treatment included bladder diaries, dynamic pad weight test, urodynamics, and a quality-of-life survey. For treatment the patients were seated fully clothed in a Neocontrol chair with a magnetic field therapy head in the seat. Treatment sessions were for 20 minutes, twice a week, for 6 weeks. After ExMI therapy, all of the measures were repeated at 8 weeks, including the dynamic pad weight testing and quality-of-life survey. At 6 months, further data were added, including repeat bladder diary, pad use, and quality-of-life survey. Forty-seven women completed 6 months of follow-up; of the 47, 13 patients were completely dry (28%) and 25 used no pad or less than 1 pad per day (53%). Pad use was reduced in 33 patients (70%). The median number of pads was reduced from 2.16 to 1 per day (Wilcoxon signed rank test, P <0.005). The frequency of leak episodes was reduced from 3.0 to 1.7 at 6 months (Wilcoxon signed rank test, P = 0.004). Detrusor instability was demonstrated in 10 before and 6 after ExMI (P <0.05). ExMI offers an alternative approach for the treatment of urinary incontinence. ExMI therapy is effective for both stress and urge incontinence. The best results are achieved in those patients who use no more than 3 pads a day and have had no prior continence surgery.
We designed an investigational study and placebo controlled trial to evaluate the efficacy of magnetic stimulation of the sacral roots for treating urinary frequency and urge incontinence.
A total of 48 women 43 to 75 years old (mean age 61) with the complaint of urinary frequency and/or urge incontinence were studied. We applied 15 Hz. repetitive magnetic stimulation of the sacral roots with 50% intensity output for 5 seconds per minute for 30 minutes. Urodynamic investigations during magnetic stimulation were performed in 11 cases to evaluate acute effects for lowering urinary tract function. Another 37 women were enrolled in a placebo controlled study to investigate short-term effects. The mean number of voids daily, mean urine volume per void, number of leaks for 3 days and quality of life score were evaluated before and 1 week after stimulation.
Urodynamic investigations revealed apparent elevation in mean maximum urethral closure pressure plus or minus standard deviation during stimulation in all 11 cases (8.4 +/- 3.6 cm. water, p = 0.00001) and a significant increase in mean bladder capacity after stimulation (58.2 +/- 50.2 ml., p = 0.003). In the placebo controlled study all parameters significantly improved in the active stimulation group. Intergroup comparison showed that mean urine volume per void, mean number of leaks and mean quality of life score improved more significantly in the active than in the sham stimulation group (23.5 +/- 25.6 ml. versus 6.2 +/- 22.5, p = 0.04, 3.6 +/- 4.1 versus 0.4 +/- 1.4, p = 0.04 and 1.4 +/- 1.3 versus 0.4 +/- 0.8, p = 0.01, respectively). No adverse effects were noted in any patients.
These results suggest that magnetic stimulation of the sacral roots may be useful for treating urinary frequency and urge incontinence.
To determine the efficacy and safety of functional magnetic stimulation (FMS) produced by the Pulsegen device compared with placebo in the treatment of women with urinary incontinence.
Fifty-five women with urinary incontinence were randomly assigned to the active FMS group (30 patients) or the placebo group (22 patients). Each patient in the active group received a Pulsegen device, which produced a pulsating magnetic field of B = 10 microT intensity and a frequency of 10 Hz. Patients were asked to wear the Pulsegen device day and night for 2 months. Clinical and urodynamic data were collected before and after FMS and analyzed using nonparametric statistics.
Compared with the placebo, the number of pads used was significantly lower (P = 0.0031) after FMS, as was the pad weight (P = 0.014). In patients from the active group, a significant improvement in the power of the pelvic floor muscle contractions (P = 0.0071), as well as in the duration of the pelvic floor muscle contractions (P = 0.038), was observed. After FMS, a 56.3% improvement in urinary incontinence symptoms was reported by patients in the active group, a significantly greater difference (P = 0.00012) compared with the reported 26.3% improvement in symptoms in the placebo group.
We believe that FMS represents a new method in the conservative treatment of urinary incontinence. Magnetic stimulation with the Pulsegen device is efficient and safe. It can be used at home and, because of its small size, wearing the device is not annoying for patients.
To evaluate the effect of magnetic stimulation of the pelvic floor (MSPF) on involuntary detrusor activity observed during natural filling, and on the overactive bladder symptom complex.
Eighteen women with detrusor overactivity on conventional cystometry underwent ambulatory urodynamic monitoring over two filling cycles. Fluid intake was standardized, provocative manoeuvres applied at regular intervals and symptoms documented contemporaneously. During the second filling cycle MSPF was delivered whenever the detrusor pressure increased by > 5 cmH2O. The women were subsequently treated with MSPF for 6 weeks; their lower urinary tract symptoms were assessed before and after treatment.
Comparing the second (stimulated) cycle with the first (unstimulated) cycle, cystometric capacity was higher (373 vs 224 mL, P < 0.03). and involuntary detrusor activity of shorter duration (370 vs 427 s, P < 0.82) and lower amplitude (53 vs 63 cmH2O, P < or = 0.05). All women tolerated the procedure comfortably, but nine found it too time-consuming and withdrew. In the nine women who completed treatment there was no consistent change in overactive bladder symptoms.
In this pilot study, MSPF during natural filling was associated with a decrease in the amplitude of involuntary detrusor contractions and a significant increase in cystometric capacity. However, MSPF had a variable effect on sensations of urgency, both acutely and after treatment, and currently there is no evidence to suggest that MSPF has an enduring effect on symptoms of the overactive bladder.
Transcranial magnetic stimulation (TMS) is a non-invasive tool for the electrical stimulation of neural tissue, including cerebral cortex, spinal roots, and cranial and peripheral nerves. TMS can be applied as single pulses of stimulation, pairs of stimuli separated by variable intervals to the same or different brain areas, or as trains of repetitive stimuli at various frequencies. Single stimuli can depolarise neurons and evoke measurable effects. Trains of stimuli (repetitive TMS) can modify excitability of the cerebral cortex at the stimulated site and also at remote areas along functional anatomical connections. TMS might provide novel insights into the pathophysiology of the neural circuitry underlying neurological and psychiatric disorders, be developed into clinically useful diagnostic and prognostic tests, and have therapeutic uses in various diseases. This potential is supported by the available studies, but more work is needed to establish the role of TMS in clinical neurology.
Stimulation of frog nerves and of excised frog muscles submerged in Ringer's solution has been obtained without the use of electrodes by means of sinusoidal alternating magnetic fields. This effect is due to eddy currents induced in conductive tissues and their surroundings. Visual and non-visual sensations have been induced in human subjects by non-homogeneous alternating magnetic fields adjacent to the brain.
To evaluate the clinical efficacy of extracorporeal magnetic stimulation for the treatment of stress and urge urinary incontinence in women.
A total of 35 patients with stress incontinence and 17 with urge incontinence were enrolled in this study. All patients were evaluated by means of a detailed history of incontinence, a gynecologic examination, urine culture, urinary system ultrasound and a urodynamic study. All patients were asked to keep a 3-day voiding diary. A pad-weighing test was done for each patient at their first visit. For treatment, the patients were seated on a special chair containing a magnetic field generator. Pelvic floor muscle stimulation was performed for 20 min (10 min at 5 Hz and 10 min at 50 Hz) twice a week for a total of 8 weeks. The mean follow-up period was 16.8 months (range 12-32 months). A total of 44 patients completed 1 year of follow-up and were re-evaluated by means of voiding diary, pad-weighing test and cystometric study.
Of the 44 patients, 11 (38%) with stress incontinence and 6 (40%) with urge incontinence were cured 1 year after the treatment. In addition, there was an improvement in symptoms in 12 patients (41%) in the stress group and 7 (47%) in the urge group. Pad weight was reduced from 15.4 to 5.8 g in the stress group and from 12.4 to 4.7 g in the urge group (p = 0.000 and 0.001, respectively). Mean Valsalva leak point pressure was increased from 87.3 +/- 15.9 to 118.0 +/- 11.0 cmH (2) O in the stress group (p = 0.000).
Extracorporeal magnetic stimulation therapy offers a non-invasive, effective and painless treatment for stress and urge incontinence in women.
To evaluate, in a prospective study, the efficiency and applicability of functional magnetic stimulation (FMS) of the pelvic floor for treating urinary incontinence in women.
FMS was provided by a 'magnetic chair'; 24 patients were treated twice weekly for 8 weeks (12 with urge incontinence and 12 with a mixture of urge and stress incontinence). The outcome was assessed urodynamically, by a pad test, and by patient satisfaction.
In 58% of the patients there was an objective improvement in incontinence; three patients were completely dry and 71% reported a subjective improvement (P < 0.001).
FMS is a safe, noninvasive and painless treatment for urinary incontinence; it is effective and easy to administer as an outpatient treatment.
Extracorporeal magnetic innervation (ExMI) is a new technology used for pelvic muscle strengthening for the treatment of stress urinary incontinence. We explored whether this new technology is effective for patients with urge incontinence, as well as those with stress urinary incontinence.
We studied 20 patients with urge incontinence and 17 patients with stress urinary incontinence. The Neocontrol system (Neotonus Inc., Marietta, GA) was used. Treatment sessions were for 20 min, twice a week for 8 weeks. Evaluations were performed by bladder diaries, one-hour pad weight testing, quality-of-life surveys and urodynamic studies.
Of the urge incontinence cases, five patients were cured (25.0%), 12 patients improved (60.0%) and three patients did not show any improvement (15.0%). Leak episodes per day reduced from 5.6 times to 1.9 times at 8 weeks (P < 0.05). Eight patients with urge incontinence recurred within 24 weeks after the last treatment (47.1%). Of the stress incontinence cases, nine patients were cured (52.9%), seven patients improved (41.1%) and one patient did not show any improvement (6%). In one-hour pad weight testing, the mean pad weight reduced from 7.9 g to 1.9 g at 8 weeks (P < 0.05). Three patients returned to the baseline values within 24 weeks after the last treatment (17.6%). No side-effects were experienced by any of the patients.
Although the results for urge incontinence were less effective than for stress urinary incontinence, ExMI therapy offers a new option for urge incontinence as well as stress urinary incontinence.
We reviewed the literature on the application of various devices and techniques for the electrical stimulation treatment of lower urinary tract dysfunction with respect to mechanism of action and clinical outcome.
A systematic review was done in PubMed of publications on intravesical stimulation, direct bladder stimulation, stimulation of the pelvic and pudendal nerves, transcutaneous-electrical nerve stimulation, stimulation of the sacral spine and roots, and lower limb stimulation.
It is difficult truly to compare different treatment modalities because there are hardly any randomized placebo controlled studies. Also, there is considerable variety in treatment parameters and schedules reported as well as in criteria for success. Nevertheless, it can be said that electrical neurostimulation and neuromodulation result in a 30% to 50% clinical success on an intent to treat basis. Influencing lower urinary tract innervation at the level of sacral roots seems successful in neurological and nonneurological cases. It has the advantage of pretesting possibilities to improve patient selection and treatment outcome with the obvious drawback of invasiveness. Noninvasive techniques lack screening tests, making patient selection a matter of trial and error, and when there is success patients almost always need maintenance therapy.
Randomized clinical trials to compare different techniques and evaluate placebo effects are urgently needed, as are further studies to elucidate modes of action to improve stimulation application and therapy results. The introduction of new stimulation methods may provide treatment alternatives as well as help answer more basic questions on electrical neurostimulation and neuromodulation.
To perform a randomized comparative study to investigate the clinical effects of extracorporeal magnetic innervation (ExMI) and functional electrical stimulation (FES) on urinary incontinence after retropubic radical prostatectomy.
Thirty-six patients with urinary incontinence after radical prostatectomy were randomly assigned to three groups (12 patients each in the FES, ExMI, and control groups). For FES, an anal electrode was used. Pulses of 20-Hz square waves at a 300-micros pulse duration were used for 15 minutes twice daily for 1 month. For ExMI, the Neocontrol system was used. The treatment sessions were for 20 minutes, twice a week for 2 months. The frequency of the pulse field was 10 Hz for 10 minutes, followed by a second treatment at 50 Hz for 10 minutes. For the control group, only pelvic floor muscle exercises were performed. Objective measures included bladder diaries, 24-hour pad weight testing, and a quality-of-life survey, at 1, 2, and 4 weeks and 2, 3, 4, 5, and 6 months after removing the catheter.
The leakage weight during the 24 hours after removing the catheter was 684, 698, and 664 g for the FES, ExMI, and control groups, respectively. At 1 month, it was 72, 83, and 175 g (FES versus control, P <0.05) and at 2 months was 54, 18, and 92 g (ExMI versus control, P <0.05) in the FES, ExMI, and control groups, respectively. Finally, 6 months later, the average 24-hour leakage weight was less than 10 g in all groups. Quality-of-life measures decreased after surgery, but gradually improved over time in all groups. No complications were noted in any of the groups.
ExMI and FES therapies offered earlier continence compared with the control group after radical prostatectomy. We consider ExMI and FES to be recommendable options for patients who want quick improvement of postoperative urinary incontinence.
We evaluate the perineal magnetic stimulation (PMS) effect on continence and quality of life in women with urinary incontinence.
We prospective studied 91 women with demonstrable urinary incontinence treated with 16 sessions of PMS. Pretreatment and posttreatment evaluation was done by clinical history, physical examination, voiding diary, validated quality of life survey (I-QOL) and urodynamic study (UDS). Patients with no leakage after treatment were evaluated at 3, 6 and 12 months.
Mean patient age +/- SD was 60.5 +/- 10.1 years. Immediately after treatment the I-QOL score increased 35% (p <0.001), the number of pads daily decreased 40% (p <0.001), the number of leaks daily decreased 54% (p <0.001) and 34 patients (37%) became dry. Of the 91 patients 41 were evaluated before and after treatment by UDS. The average increase in vesical leak point pressure (VLPP) was 24.3% (p = 0.001) and initial VLPP in patients who became dry was greater than 80 cm H2O. After treatment 77% of patients with initial low pressure detrusor overactivity on UDS became free of this condition. One year after discontinuing PMS 94% of patients who became dry immediately after treatment had recurrence.
Immediately after 16 sessions of PMS women with urinary incontinence have significant improvement in the I-QOL score with decreased daily pad use and leakage episodes but 63% had failure. Therapy is more effective in patients with a VLPP of greater than 80 cm H2O. The beneficial effect is temporary with high and early recurrence after discontinuing treatment.
Management of urinary incontinence in women
- Holroyd-Leduc
Magnetic stimulation of the sacral roots for the treatment of urinary frequency and urge incontinence: an investigational study and placebo controlled trial
- Fujishiro