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Titanised Transobturator Sling Placement for Male Stress Urinary Incontinence Using an Inside-Out Single-Incision Technique: Minimum 12-Months Follow-Up Study
Abstract
Objective:
To evaluate prospectively midterm outcomes of a new titanium-coated fixed polypropylene sling for male stress urinary incontinence.
Materials and methods:
From 01/2013 to 06/2016, 44 consecutive patients with incontinence caused by radical prostatectomy (39) or TURP (5) underwent transobturator two-arm titanium-coated sling (TiLOOP Male®) implantation with an inside-out, single-incision technique, leaving the bulbourethral muscle in place. Patients have been assessed postoperatively with uroflowmetry, pad count, ICIQ-SF, IIQ-7, PGI-I, OABq, IPSS, satisfaction (yes/no). Successful outcome included cure (no pad use or one dry "security" pad) or improvement (reduction of at least 50% of the pad count).
Results:
Evaluated patients were suffering from mild (11/44, 25%), moderate (26/44, 59%) or severe (7/44, 16%) incontinence. After a median follow-up of 25 months (range 12-55, minimum 12 months), 24(54.6%) patients were cured and 10(22.7%) were improved, which was a global success rate of 77.3%. There were 10(22.7%) failures in the first 6 months. Zero pad rate was 50%. Subjective success (PGI-I very much/much improved) was achieved in 33(75%) patients. Mean scores of ICIQ-SF, ICIQ-QoL and IIQ-7 improved to a statistical significant extent. Satisfaction was reported by 33(75%) patients. Uroflowmetry parameters were unchanged postoperatively, and most of complications were Clavien-Dindo grade I. BMI≥30 and previous irradiation/HIFU were independent predictors of failure.
Conclusions:
TiLOOP Male®provided favourable and stable midterm continence outcomes. The inside-out approach was safe, and the tolerability of the sling and the single-incision technique was satisfactory. Patients with obesity and previous irradiation/HIFU should be aware of their higher risk of failure.
... Severe PPI did seem to negatively affect continence outcomes after RTS implantation in several series [9][10][11], consequently RTS are recommended for mildto-moderate PPI [2]. As a result, moderate PPI, that affects the 40-60% of all patients with PPI in clinical practice [10,12,13], is in a 'grey area' in which both AUS and RTS are indicated. ...
... The TiLOOP Male is a type 1, lightweight (65 g/m 2 ), titanium-coated polypropylene mesh, 40 9 1.5 cm in 230 © 2020 The Authors BJU International © 2020 BJU International dimension with a 4-cm central part [12,19]. All surgeries were performed by the same surgeon (E.S.) using a standardised perineal approach and attaining a retroluminal re-positioning urethral suspension [10,12]. ...
... The TiLOOP Male is a type 1, lightweight (65 g/m 2 ), titanium-coated polypropylene mesh, 40 9 1.5 cm in 230 © 2020 The Authors BJU International © 2020 BJU International dimension with a 4-cm central part [12,19]. All surgeries were performed by the same surgeon (E.S.) using a standardised perineal approach and attaining a retroluminal re-positioning urethral suspension [10,12]. Briefly, a 5-6 cm sagittal skin incision was made at the median raphe of the perineum, and the bulbospongiosus and ischiocavernosus muscles were exposed. ...
Introduction:
To compare the efficacy of artificial urinary sphincter (AUS) versus retrourethral transobturator sling (RTS) in men with moderate postprostatectomy urinary incontinence (PPI) using the propensity score-matching (PSM) to enhance the validity of the comparison (Canadian Task Force classification II-2).
Patients and methods:
Consecutive men suffering from moderate (3-5 pad use daily) stress-prevalent PPI were included if implanted with with RTS (TiLOOP® Male) or AUS (AMS800®) since July 2011 to December 2017 and with at least 12 months follow-up. Preoperative assessment included 24h pad usage, International Consultation on Incontinence-Short Form (ICIQ-SF) questionnaire, urethrocystoscopy and urodynamics if indicated. Propensity score matching was based on age, body mass index, Charlson's comorbidity index, pad usage, previous radiotherapy, and urethrotomy. Primary outcome was at least much improved response at 12-months Patient Global Impression of Improvement questionnaire without additional PPI surgery or explantation.
Results:
Out of 109 included patients, 70 patients were matched and the study groups were well balanced for the baseline matched variables. Median baseline 24h pad usage was four in both groups (p=0.10), and median follow-up was 51.2 months for AUS and 47.2 months (p=0.5) for RTS patients. In AUS and RTS cohort, respectively, 33 (94.3%) and 24 (68.6%) patients achieved the primary outcome, 0-1 pad per day rates were 94.3% vs. 68.6% (p=0.012) at 12 months, and 91.4% vs. 68.6% (p=0.034) at last follow-up. Last follow-up median 24h leakage volumes, median ICIQ-SF scores and satisfaction rates were 0 vs. 15 ml (p=0.017), 4 vs. 10 (p=0.001), and 94.3% vs. 68.6% (p=0.012) in the AUS and RTS cohort, respectively. No significant differences were observed in overall rates of complications and reinterventions, although Clavien grade 3 complications (n=3) occurred in the AUS group only. At sensitivity analysis, the study was reasonably robust to hidden bias.
Conclusion:
AUS implantation significantly outperforms RTS in patients with moderate PPI for both subjective and objective outcomes.
... This material has been proven to be safe in recent studies and seems to be superior to conventional mesh. For example, titanised transobturator slings provided favourable midterm continence outcomes in male patients with SUI [13]. ...
... To our knowledge, this is the first study comparing outcomes of titanium-covered mesh tape to those of uncovered polypropylene mesh tape in women. The results are consistent with those of similar studies about titanium tape use in men [13]. ...
Introduction and hypothesis
To assess the long-term satisfaction, cure rate and safety of a new titanium-covered transobturator tape compared to polypropylene tape for the treatment of stress urinary incontinence (SUI).
Methods
A prospective study was conducted with 151 patients. Seventy patients underwent transobturator sling surgery with titanium tape from 2011 to 2019, and a historical control group (CG) of 81 patients was treated with a noncoated tape and underwent incontinence surgery from 1999 to 2009. We compared patient-reported outcome measures (PROMs) with the incontinence outcome questionnaire (IOQ).
Results
The median follow-up was 2½ years in both groups. Based on responses to the IOQ, a statistically significantly shorter time of recovery (IOQ 15: 21.3 ± 26.4 [TG], 40.2 ± 38.5 [CG], p = 0.02), improvement of sex life (IOQ 13: 34.1 ± 29.4 [TG] vs. 65.3 ± 35.6 [CG], p = 0.01) and less voiding dysfunction (IOQ 19: 30.9 ± 28.1 [CG], 9.3 ± 18.6 [TG], p = 0.01) were observed in the TG. Objectively, no postoperative urinary retention was observed in the TG, but four cases were described in the CG. Ten patients needed a reoperation for SUI in the CG compared to three in the TG ( p = 0.03).
Conclusion
The titanium-covered transobturator sling had superior recovery time, improved sexual function and reduced reoperation rate compared to a historical polypropylene group.
... [5][6][7] Anecdotally, men with obesity are considered more challenging surgically for placement of a retrourethral sling because of body habitus challenges associated with passing the trocar, however, there are few studies examining the impact of obesity on male sling surgery or outcomes. 8,9 The aim of this study was to evaluate the impact of obesity on AdVance male urethral sling placement, focusing on operative time as a surrogate for surgical complexity and need for pads postoperatively. ...
... In addition, Sacco et al. reported that patients with a BMI of 30 or higher and those with prior radiation experienced a higher incidence of failure within 6 months of surgery. 9 Our findings corroborate each of these studies despite the fact that we were unable to evaluate fully the impact of radiation given our small numbers. ...
Background
The impact of obesity on AdVance male urethral sling outcomes has been poorly evaluated. Anecdotally, male urethral sling placement can be more challenging due to body habitus in obese patients. The objective of this study was to evaluate the impact of obesity on surgical complexity using operative time as a surrogate and secondarily to evaluate the impact on postoperative pad use.
Methods
A retrospective cohort analysis was performed using all men who underwent AdVance male urethral sling placement at a single institution between 2013 and 2019. Descriptive statistics comparing obese and non-obese patients were performed.
Results
A total of 62 patients were identified with median (IQR) follow up of 14 (4–33) months. Of these, 40 were non-obese and 22 (35.5%) were obese. When excluding patients who underwent concurrent surgery, the mean operative times for the non-obese versus obese cohorts were 61.8 min versus 73.7 min ( p = 0.020). No Clavien 3–5 grade complications were noted. At follow up, 47.5% of the non-obese cohort and 63.6% of the obese cohort reported using one or more pads daily ( p = 0.290). Four of the five patients with a history of radiation were among the patients wearing pads following male urethral sling placement.
Conclusion
Obese men undergoing AdVance male urethral sling placement required increased operative time, potentially related to operative complexity, and a higher proportion of obese compared with non-obese patients required postoperative pads for continued urinary incontinence. Further research is required to better delineate the full impact of obesity on male urethral sling outcomes.
... In a series of 34 patients with mixed postprostatectomy urinary incontinence, Lai et al. observed a resolution of OAB symptoms in 29% of patients after artificial urinary sphincter implantation [47•]. Two series have evaluated the impact on OAB symptoms of male slings for postprostatectomy incontinence on OAB symptoms [48,49]. In the first one, Yiou et al. reported a significant improvement of the Urinary Symptom Profile (USP) OAB subscore at 6 and 12 months after TOMS sling implantation [48]. ...
... In the first one, Yiou et al. reported a significant improvement of the Urinary Symptom Profile (USP) OAB subscore at 6 and 12 months after TOMS sling implantation [48]. In the second study, Sacco et al. found a trend towards improved OABq score at the latest follow-up after TiLOOP sling implantation [49]. Finally, in a series of 20 male patients with failed slings who underwent subsequent adjustable continence therapy (proACT) implantation, a significant improvement of USP OAB subscore was noted 1 year after proACT implantation [50]. ...
Purpose of Review
Post-prostatectomy overactive bladder (OAB) is a common and challenging condition to manage. The aim of the present report was to review the recent evidences regarding OAB symptoms that develop in men after prostatectomy and how to manage them.
Recent Findings
The prevalence of OAB after radical prostatectomy may range from 15.2 to 37.8%. Recent studies have highlighted the role of the urethrogenic mechanism (facilitation of the urethrovesical reflex due to stress urinary incontinence (SUI)) in the genesis of post-prostatectomy OAB in a significant proportion of patients. Several other pathophysiological factors such as iatrogenic decentralization of the bladder, defunctionalized bladder due to severe SUI, detrusor underactivity, or bladder outlet obstruction might be involved. The evaluation should aim to identify the underlying mechanism to tailor the treatment, which could range from SUI surgery, to fixing a urethral stricture, improving bladder emptying or using the conventional spectrum of OAB therapies. There is a paucity of data for OAB therapies specific to post-prostatectomy patients, with the exception of solifenacin, tolterodine, and botulinum toxin. There is currently no data on how preoperative management or surgical technique may prevent post-prostatectomy OAB.
... This carried the apparent advantage of minimizing inflammation, shrinkage, and sling migration. In a study of 44 patients with midterm follow-up, objective and subjective improvement were nearly consistent at 77% and 75% with a median follow-up of 25 months (54). Although this device is no longer available on the company website, some argue perhaps it was prematurely disregarded (55). ...
... By contrast, count of pads used per day is widely used, including in randomized controlled trials [16], as an estimation of UI severity [13][14][15], and has shown to be a reliable measure of urine leakage volume in an ambulatory setting [5]. While pad tests are somewhat cumbersome and time-consuming, pad count recorded by the patients/ caregivers for 24 h or a number of days is definitely a more streamlined method. ...
Introduction
To determine in a large population of community‐dwelling incontinent patients the accuracy and determinants of pad count as measure of urinary incontinence (UI), using data from a multicentre 48‐hour pad test study.
Materials and methods
Incontinent subjects provided with absorbent products from 01/2012 to 03/2016 volunteered to perform a 48‐hour home‐based pad test and to fill in a diary with information on pad usage. Correlations between UI measures (48‐hour pad count and pad weight gain, mean pad weight gain per pad) were calculated. Logistic regression analyses were conducted to investigate patient‐related and pad usage‐related factors influencing pad count.
Results
14,493 patients (median age 81 years) were included, using overall during the study days 98,362 continence products. 48‐hour pad count showed a weak correlation with 48‐hour pad weight gain (R²=0.12; 0.19 for males and 0.11 for females) and mean pad weight gain per pad (R²=‐0.03). The weakest correlation was observed among subjects using >6 pads/48‐hour (R² = 0.02). A statistically significant negative association between pads’ absorption capacity and pad count was observed. Patients using products with shaped and rectangular design had 34% and 40% higher propensity to use more pads than those using briefs (p<0.0001), respectively.
Conclusions
This study confirmed on a very large observational base that pad count is a poor measure of UI severity. Pad count only measured 12% of the variability of UI volume and resulted to be affected by several patient‐related and pad usage‐related factors. Consequently, pad count should not be used instead of the pad test as an objective measure of UI when an accurate evaluation is required for research or clinical purposes.
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Background:
The male sling has emerged as a minimally invasive option for incontinence after prostate treatment (IPT) in recent years, but it has not yet been introduced into China. This study retrospectively evaluated the clinical outcomes of the modified female mid-urethral sling in the treatment of IPT and explored potential preoperative factors to better predict surgical outcomes.
Methods:
From May 2014 to January 2021, a total of 70 patients with IPT who underwent transobturator male sling procedure using the modified female mid-urethral sling were retrospectively reviewed. All surgeries were performed by a single surgeon. Functional outcomes were evaluated by daily pad usage, and the severity of incontinence was classified as mild (≤2 pads), moderate (3-4 pads), or severe (≥5 pads). Success was defined as no pad usage or 1 pad for safety (cure), or a reduction in daily pad use by >50% (improved). Patients were followed up at 3, 6 months, and yearly thereafter.
Results:
At a final follow-up of 6-80 months, 35 (50.0%) patients were cured, 12 (17.1%) were improved, and 23 (32.9%) were still incontinent. There was a slight trend of declining continence over time, and the majority of patients remained improved. During follow-up, 25 patients had perineal or scrotal pain, five patients had voiding difficulty and two had de novo urgency, one developed infection and underwent sling explantation. Early urinary retention was the only significant factor linked to better surgical outcomes.
Conclusion:
The modified female mid-urethral sling represents a viable option for the treatment of IPT. Improved efficacy is seen in patients with a history of early postoperative urinary retention.
Purposes
Little research exists on potential learning curve for male sling procedures. We aimed to perform a learning curve analysis of a single surgeon’s experience of sling placement evaluating multiple outcomes and using the cumulative sum failure methodology.
Methods
The study included 65 consecutive patients that underwent implantation of a fixed transobturator sling (TiLOOP Male) for post-radical prostatectomy stress incontinence at our institution from January 2013 to December 2018. Dichotomous outcomes evaluated with cumulative sum failure analysis included 12-months continence defined based on Patient Global Impression of Improvement (PGI-I) questionnaire (primary outcome), 24 h pad test and, 24 h pad use, operative time (⩽/>60 min), and complications (yes/no). Univariate and multivariate logistic regression analyses were performed to evaluate the association of the procedures’ chronological sequence number with the outcomes.
Results
Cumulative sum failure curves revealed a clear and lengthy learning curve effect for most of subjective and quantitative continence outcomes and for operative time. For the primary outcome (at least much improved at PGI-I), 62 procedures were required to overcome the learning curve. Accordingly, multivariate analyses showed that the sequence number was statistically significant for predicting failures based on PGI-I (adjusted OR 0.95; 95% CI: 0.91–0.99; p = 0.02), objective outcomes, and operative time.
Conclusions
An evident and lengthy learning curve was observed in our series of male sling placement to achieve the end level of proficiency, independently from case-mix. Individualized structured training on male sling surgery will benefit patients treated in the initial surgeon’s experience. Surgical experience should be considered when reporting studies on male slings.
Aims
This prospective multicenter observational study evaluated postprostatectomy incontinence treatment outcomes with Virtue male sling at 12 and 36 months.
Methods
Objective assessment was based on a 24-h pad weight test with improvement defined by a decrease >50% and cure by less than 1.3 g. Subjective assessment was based on the patient global impression of improvement and International Consultation on Incontinence Questionnaire-urinary incontinence-short form (ICIQ-UI-SF) questionnaires. Subgroups were analyzed by baseline severity of incontinence on a 24-h-pad test, body mass index (BMI), and pads usage. Factors associated with treatment response were assessed using logistic regression at Months 36. Complications were reported.
Results
We analyzed data from 117 men. Objective and subjective improvement were achieved in 54% and 35% and 51% and 34% at 12 and 36 months, respectively. Twenty-one percent and 19% were considered cured, respectively, at 12 and 36 months. No differences per baseline incontinence severity, BMI and pads usage were found at 36 months. Mean ICIQ-UI-SF score decreased from 15 to 9. Predictive factors were BMI, postvoid residual urine, number of nighttime urination, and ICIQ total score. Seven Clavien–Dindo Grade III (5.1%) including four Virtue sling revisions were reported. The most frequent Grade II complications were overactive bladder symptoms and pain reported in 10.3% and 2.9%, respectively. No complications required explantation.
Conclusions
Virtue male sling is safe and effective in males with mild to severe postprostatectomy urinary incontinence over 36 months. Virtue could be considered an interesting option for postradical prostatectomy urinary incontinence with positive results over time even in patients with high BMI. The predictive model should be validated by further studies.
Objective: To evaluate the factor age at the surgery on long-term postoperative outcomes in patients with postprostatectomy incontinence (PPI) after AdVance XP transobturator male sling implantation.
Methods: A total of 115 male patients with PPI, who had undergone AdVance XP sling implantation, were included. Patients had PPI with endoscopically confirmed good sphincteric-contractility and a positive coaptive response. Kruskal-Wallis test with Dunn post-hoc tests were used to analyze the postoperative outcome differences between the patient groups aged less than 66, 66-75, and over greater than 75 years. Outcome measures were the 24 h pad test, the number of daily pads used, the International Consultation on Incontinence Questionnaire short form (ICIQ-SF), International Quality of Life Score (IQOL), Patient Global Impression of Improvement (PGI-I), International Index of Erectile Function-5 (IIEF-5), International Prostate Symptom Score (IPSS), and Visual Analog Scale scores. Observation time points were 3, 6, 12, 24, 36, 48, 60, and 84 months after surgery.
Results: Between the age groups, there was no difference in the success rate of the procedure (defined as 0 pads/24 h and less than 5 g in the 24-h pad test) at any point in time. Subjective parameters measures using the ICIQ-SF, PGI-I, IQOL, and IPSS scores showed no differences between the two cohorts. Only erectile function (IIEF-5 score) was lower in older patients in comparison to the cohort aged less than 66 years (p < 0.05 at 3, 6, 12, 24, 36, and 48 months).
Conclusions: The present study complements the European multicentre AdVance XP follow-up study. Here, we show that age at surgery does not affect the objective success, subjective success, or the complication rate. Thus, we do not recommend factoring in chronological age into surgical selection criteria for the AdVance XP implantation.
Context:
Male slings are recommended by the European Association of Urology guideline for the treatment of mild to moderate postprostatectomy incontinence. However, none of them has been proved to be superior to the others, and there are no defined guidelines to preference of a given sling model.
Objective:
To evaluate and compare the efficacy and safety of the different types of male slings in the treatment of postprostatectomy incontinence.
Evidence acquisition:
This systematic review and meta-analysis was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis statement. A systematic literature search in the databases of PubMed, Embase, and Cochrane using the keywords "incontinence," "prostatectomy," and "male sling/system" was conducted in June 2018. Studies in English with at least 15 patients and a minimum follow-up of 12 mo were included. As the primary endpoint, we assessed the cure rate of the different sling types. As secondary endpoints, we assessed the improvement rate, subjective cure rate, overall complication rate, explantation rate, risk factors for failure, and effect on patients' quality of life.
Evidence synthesis:
The literature search identified 833 articles. A total of 64 studies with 72 patient cohorts were eligible for inclusion. Fixed slings were implanted in 55 (76.4%) of the patient cohorts. The objective cure rate varies between 8.3% and 87% (pooled estimate 0.50, 95% confidence interval [CI] 0.45-0.56, I2=82%). Subjective cure was achieved in 33-94.4%. Adjustable slings showed objective cure rates between 17% and 92% (pooled estimate 0.61, 95% CI 0.51-0.71, I2=88%). The subjective cure rate varies between 28% and 100%. In both types of slings, pain was the most common complication, but chronic painful conditions were really rare (1.3% in fixed slings and 1.5% in adjustable slings). The most common complication after pain was urinary retention in fixed slings, and infection and consequential explantation in adjustable slings.
Conclusions:
Both fixed and adjustable slings are beneficial for the treatment of postprostatectomy incontinence. Although adjustable slings might lead to higher objective cure rates, they might be associated with higher complication and explantation rates. However, at present, due to significant heterogeneity of the data, this cannot be said with certainty. More randomized controlled trials with long-term follow-up and the same definition for continence are needed.
Patient summary:
Fixed and adjustable slings are effective treatment options in mild to moderate postprostatectomy incontinence.
Comparative analysis of the proliferative activity of inflammatory cells and distribution of collagen types I and III was carried out around the net materials of polypropylene and titanium coating polypropylene using im- munohistochemical method and polarization microscopy. Experimental modeling of implanted mesh material were made in the soft tissues of the lumbar region of rats. On the 7th postoperative day, quantitative analysis of proliferating cells delected using antibodies to the Ki-67 protein showed, a significant decrease (p < 0.001) in the number of proliferating cells around the network elements of the polypropylene (29.1 ± 5.7 %), when com- pared to similar figures of infiltrates in titanium coating polypropylene (33.6 ± 3.1 %). Similar patterns were found on the 30th day of the experiment--15.9 ± 4.3 and 26.9 ± 3.6%--respectively (p < 0.001). Different types of collagen fibers in the granulomas around various types of implanted mesh material were detected on sections stained with Sirius red at polarizing light. On the 7th day after surgery, the ratio of collagen fibers ty- pe I and III in granulomas around the mesh material made of polypropylene was 1.085 ± 0.022 and this rati around materials of titanium coated polypropylene was higher--1.107 ± 0.013 (p = 0.017). On the 30th posto- perative day in the interface area ratio I/III collagen significantly increased and amounted to 1.174 ± 0.036 and 1.246 ± 0.102, respectively (p = 0.045). Assessing the impact of the use of titanium as a coating on the po- lypropylene, it can be argued that it promotes the formation of collagen I type and a more mature connective tis- sue around the mesh of the implants.
In light of the fact that, to date, no information is available about titanium relative to its application in prosthetic material employed for hernial repair, the aim of the present work was to evaluate the fundamental possibilities of titanium-coated polypropylene meshes.
In experiments with animals, two groups, each containing 11 pigs, received either a heavyweight polypropylene mesh (Atrium) or an identical but titanium-coated mesh (titanium-coated Atrium) implanted into the left groin using the totally endoscopic extraperitoneal patchplasty technique.
A significant difference in the shrinkage behavior between conventional Atrium and titanium-coated Atrium was found (14.9 vs. 8.8%, p < 0.05). Furthermore, the partial volume of the inflammatory infiltrate also proved to be smaller with the titanium-coated mesh (14.9 vs. 12.4%). In addition, Ki-67 expression was lower in the group implanted with titanium-coated mesh (21.0 vs. 15.0%). No difference was observed with regard to the apoptosis index (7.6 vs. 6.5).
Heavyweight titanium-coated polypropylene meshes induce a less pronounced foreign body reaction in comparison with identical meshes with no titanium coating, which, since the amount of material implanted is identical, must be attributed solely to the titanium coating.
To investigate the incidence of urinary incontinence and its development over time, to compare the effects of alternative definitions on the incontinence rate and to explore risk factors for incontinence after radical retropubic prostatectomy (RRP) for clinically localized prostate cancer.
Urinary continence was assessed using a questionnaire administered by a third party in 1144 consecutive patients after undergoing RRP at our department from January 1986 to December 2001. Overall, 985 men (86%) were suitable for evaluation (mean age 64.5 years, mean follow-up 95.5 months). We compared the effects of three definitions on the actuarial rate of continence: (1) no or occasional pad use; (2) 0 or 1 pads used daily, but for occasional dribbling only; (3) 0-1 pads daily. The time to recovery of continence was defined as the date on which the patient met the continence definitions. The impact of incontinence on health-related quality of life (HRQoL) was also evaluated. Univariate and multivariate analyses were used to identify predictors of incontinence, using data gathered prospectively.
At the last follow-up at 24 months after RRP, 83%, 92.3% and 93.4% of men achieved continence according to definitions 1, 2 and 3, respectively. The difference in time to recovering continence was significant for definition 1 compared to the others (P < 0.001). Most men using 1 pad/day complained of occasional dribbling only (89.3%), considered themselves continent (98%) and their HRQoL was not as seriously affected as those requiring > or = 2 pads/day. Men continent (by definition 3) at 2 years had an actuarial probability of preserving continence of 72.2% at the last follow-up. On multivariate analysis the age at surgery (P = 0.009), anastomotic stricture and follow-up interval (both P < 0.001) were independent prognostic factors. Bilateral neurovascular bundle resection was another independent predictive factor (P = 0.03) in the subset of the last 560 men with available data on surgical technique. The reduction in the incidence of incontinence over time was as high as 86%.
Continence improves progressively until 2 years from RRP but some patients can become incontinent later. The criterion of pad use discriminates well between men with a limited reduction in their QoL (no or one pad used) and those with a markedly affected QoL (> or =2 pads/day). It could be clinically valid to consider users of 1 pad/day as continent. Age, bilateral neurovascular bundle resection and anastomotic stricture are significant risk factors for incontinence. There was a marked trend for the incidence of incontinence and anastomotic stricture to decrease with time.
Purpose:
To determine mid-term durability of the AdVance sling for post-prostatectomy incontinence (PPI) and impact of prior radiotherapy and storage dysfunction.
Method:
Eighty men undergoing AdVance sling for PPI during 2008-2013 were reviewed. Pre-op urodynamics, pre and post-op pad usage, prior radiotherapy, and PGI-I scores were recorded.
Result:
Mean follow-up was 36 months (range 14-72). Twelve men had radiotherapy pre-op, 10 had detrusor overactivity (DO), and 20 reduced compliance. Pre-op mean 24-hr pad weight was 264 g and mean pads-per-day (PPD) 2.60 ± 0.29. In the early post-op period (3-6 months), mean PPD was 0.40 (SD 0.16); at mid-term follow-up mean PPD was 1.02 ± 0.31. Radiotherapy and DO were independently predictive of poor mid-term outcome. Men with DO or radiotherapy were using 1.03 ± 0.42 (P = 0.019) and 1.17 ± 0.41 (P = 0.02) more PPD, respectively than men without these factors. At mid-term follow-up, men without radiotherapy or DO were using 1.98 ± 0.28 less PPD compared to pre-operatively (P < 0.0001); with radiotherapy or DO men were using 0.73 ± 0.38 (P = 0.057) and 0.72 ± 0.43 (P = 0.092) less PPD, respectively. PGI-I score for men without radiotherapy or DO was 1.98 ± 0.40 ("much better"); with radiotherapy or DO PGI-I score was 3.80 ± 0.49 ("no difference").
Conclusion:
The AdVance sling provides mid-term improvement in men with PPI. However, men with radiotherapy or DO have significantly poorer outcomes with mid-term results indicating a return to baseline degree of incontinence. Caution should be taken when considering the AdVance sling in these men. Pre-op urodynamics in men with radiotherapy and/or overactive bladder may be important when considering men for AdVance sling. Neurourol. Urodynam. © 2016 Wiley Periodicals, Inc.
Objective:
To successfully perform male sling surgery, and the surgery must achieve proximal urethral relocation and/or bulbar urethral compression. The Virtue quadratic sling is a novel device that incorporates both mechanisms of action. We report the 1-year results of the Virtue sling with fixation and compare it with the results of the initial "unfixed" sling trial.
Methods:
A prospective trial was performed to assess the efficacy and safety of the Virtue sling. Objective success was predefined as >50% decrease in 24-hour pad weight and subjective success as a score of "much" or "very much" better on the Patient Global Impression of Improvement. Subgroups were analyzed by baseline incontinence: mild (<100 g), moderate (100-400 g), and severe (>400 g). After analysis of the 1-year data, a second clinical trial incorporating a novel "fixation" technique was performed, with similar outcome measures.
Results:
In the initial cohort, subjective and objective successes were achieved in 41.9% at 12 months. Median pad weight reduction was 51.1% at 12 months and varied with the degree of baseline leakage. In the fixation cohort, subjective and objective successes were 70.9% and 79.2%, median pad weight reduction was 88.3% at 12 months, and efficacy was similar regardless of baseline incontinence. There were no cases of prolonged retention and no severe adverse events.
Conclusion:
The Virtue sling with fixation is a safe and efficacious treatment for postprostatectomy incontinence. Superior 12-month results compared with the unfixed device demonstrate that fixation prevents early sling loosening.
To determine patient-perceived and clinical outcomes of the AdVance sling at 3 years follow-up in men with post-prostatectomy incontinence (PPI).
Data was prospectively collected of men with PPI treated with the AdVance male sling between February 2008 and March 2010. Twenty-four-hour pad counts and weights and patient completed validated questionnaires were obtained pre-operatively and at 3 years. The primary outcome was improvement in pad count with secondary outcomes of questionnaire scores and patient perception of success.
At a median follow-up of 39 months (IQR: 36-44), we identified 30 men meeting inclusion criteria who had the AdVance male sling placed for mild to severe PPI. Eighteen (60%) patients were cured (no pad usage or one pad for security) and an additional 4 (13%) showed improvement (≥50% reduction in pad usage). Eight (27%) patients failed: six patients underwent seven salvage procedures including urethral bulking with collagen (n = 1), Virtue perineal sling (n = 1), and artificial urinary sphincter (n = 5). There were 16 post-operative complications: 13 Clavien I, 2 Clavien II, and 1 Clavien IIIb.
AdVance male sling is an effective treatment option for PPI evidenced by objective improvements in 24-hr pad count and pad weight and patient perceived success via validated questionnaires. Neurourol. Urodynam. © 2013 Wiley Periodicals, Inc.
A number of anatomic components work in concert to produce precise control of micturition in the healthy male, including the sphincter with its striated and smooth muscle components, the surrounding muscular and ligamentous support structures, neural components, and the urothelium. Radical prostatectomy is often associated with injury to one or more of these tissues, culminating in stress urinary incontinence (SUI). Although the causes of urinary incontinence can vary, among patients with residual urethral sphincter function, the increased laxity and reduced functional length of the membranous urethra are thought to play key roles in incontinence. Most surgical treatments for urinary incontinence, such as the artificial urinary sphincter and various slings, achieve continence via compression of the urethra, but the AdVance® transobturator retrourethral sling (American Medical Systems, Minnetonka, MN, USA) repositions the urethral sphincter complex back into the pelvis and increases the functional membranous urethral length. Emerging reports on the AdVance® sling suggest favourable cure rates and few complications. Thus, the AdVance® sling provides an alternative approach to treating postprostatectomy SUI that is both less obstructive and more dynamic.
The male transobturator AdVance™ sling is a viable option for mild to moderate post-prostatectomy incontinence. As this treatment is relatively new, our study provides an analysis of efficacy through patient reported outcomes and pad use.
A telephone survey and chart review were conducted on all patients receiving a sling before 2010 by either of 2 surgeons at a large academic institution. The survey included the Patient Global Impression of Improvement and Severity instruments, pad use characteristics before and after sling surgery, and items assessing durability of efficacy. Patient determined (subjective) success was very much or much better on the Patient Global Impression of Improvement without subsequent incontinence therapy. Quantitative success was defined as a decrease to 2 or fewer pads per day. We assessed therapeutic durability in a subanalysis of patients interviewed twice, first in a prior study.
From initial office followup to 2 years, quantitative success decreased from 87.3% to 62.5% and pad use doubled from a mean±SD of 0.8±1.7 to 1.7±2.5 pads per day. Patient determined success was 53.6% at 2 years. A subgroup of 25 patients interviewed at 7 and 29 months after sling surgery had quantitative success significantly decrease by 20% (p=0.03), subjective success decrease by 4% (p=0.56) and pad use significantly increase (p=0.01) from 1.4±2.2 to 2.3±3.2 pads per day.
Most patients receiving the AdVance sling did see improvement in post-prostatectomy incontinence and a decrease in pad use, but in 20% of patients this benefit decreased with time. Nevertheless, patients remained satisfied and perceived the treatment as successful.
Little is known regarding factors that contribute to the long term success or failure of the transobturator male sling for stress urinary incontinence. The objective of this study was to compare the outcomes of the transobturator male sling for stress urinary incontinence based on body mass index (BMI).
A retrospective review was performed of 31 transobturator male slings placed at a single institution from 2008 to 2010. Success of the procedure was defined as resolution of leakage or great improvement of leakage by the Patient Global Impression of Improvement scale and lack of urinary leakage on postoperative physical exam. Patients were divided into one of three groups: ideal weight (BMI 18.5-24.9 kg/m(2)), overweight (25-29.9 kg/m(2)), and obese (> 30 kg/m(2)). Outcomes and complications were compared between groups.
Etiology of urinary incontinence was radical prostatectomy in 28 patients and a transurethral procedure for infection or benign prostatic hypertrophy (BPH) in 3 patients. Successful treatment of incontinence was significantly higher in the ideal weight (7/8 or 88%) and overweight group (13/14 or 93%) in comparison to the obese group (4/9 or 44%), (p = 0.019). Postoperative complications were similar between groups.
Obese patients had lower success rates after transobturator sling in comparison to ideal and overweight patients. We feel this may be due to increased intra-abdominal pressure transmission to the bladder, urethra, and sling itself. These patients may be better candidates for an artificial urinary sphincter or should be counseled to undergo pre-preoperative weight loss to improve sling outcomes.
Transobturator slings are currently promoted for the treatment of stress urinary incontinence (SUI) after radical prostatectomy (RP), but data on outcome remain limited.
To assess, at midterm, the efficacy and safety of the inside-out transobturator male sling for treating post-RP SUI and to determine factors associated with failure.
Prospective one-center trial involving 173 consecutive patients without detrusor overactivity, treated between 2006 and 2011 for SUI following RP.
Placement of an inside-out transobturator sling.
Baseline and follow-up evaluations included uroflowmetry and continence and quality-of-life (QoL) questionnaires. Cure was defined as no pad use and improvement as a number of pads per day reduced by ≥50% and two or fewer pads. Complications were recorded, and factors associated with treatment failure were evaluated.
Preoperatively, 21%, 35%, and 44% of the patients were using two, three to five, and more than five pads per day, respectively. After a median follow-up of 24 mo (range: 12-60 mo), 49% were cured, 35% improved, and 16% not improved. QoL was enhanced (p<0.001), and 72% of patients were moderately to completely satisfied with the procedure. Maximum flow rates were slightly reduced (p=0.004); postvoid residual volumes were similar (p=0.097). Complications were urinary retention after catheter removal (15%), perineal/scrotal hematoma (9%), pain lasting >6 mo (3%), and sling infection (2%); all were managed conservatively. Severe SUI before sling surgery was not associated with a worse outcome, whereas obesity and a history of pelvic irradiation or bladder neck stenosis were independent risk factors of failure, with risk ratios of 7.9 (95% confidence interval [CI], 3.3-18.9), 3.3 (95% CI, 1.4-7.8), and 2.6 (95% CI, 1.1-6.5), respectively.
The inside-out transobturator male sling is an efficient and safe treatment for post-RP SUI at midterm. Patients with prior pelvic irradiation may not be suitable candidates.
Prospective evaluation of independent risk factors for failure of the retrourethral transobturator sling suspension (RTS) with special attention on sphincter function and surgical technique.
A total of 189 patients with postprostatectomy stress urinary incontinence (SUI) were treated with RTS (AdVance(®) sling) in a prospective clinical study with a mean follow-up of 20.8 months. Eleven patients were lost to follow-up. Uni- and multivariate analyses were performed to identify independent risk factors for RTS failure. The success rate was defined as cured (no pad use or one dry 'security' pad) or improved (one to two pads and pad reduction ≥ 50%).
At a mean follow-up of 20.8 months, the overall success rate was 73.1%. Multivariate analysis revealed that weak residual function and incomplete closure of the sphincter (OR, 29.0), no elongation of the coaptive sphincter zone (OR, 26.9), no sling tunnelling (OR, 22.6) and use of resorbable sutures with a small number (≤ 4) of stitches (OR, 8.4) are significant predictors for RTS failure.
Preoperative selection of the patients with regard to residual sphincter function and a special attention on better sling fixation may increase RTS efficacy.
To prospectively evaluate the efficacy of the functional AdVance transobturator sling for the treatment of male stress urinary incontinence (SUI) in patients after radical prostatectomy and additional adjuvant radiotherapy.
Between February 2007 and November 2008, 24 patients with postprostatectomy SUI (ICS grade 2-4) and additional adjuvant radiotherapy were treated consecutively with the AdVance sling. Preoperatively, intensive workup, including urodynamic assessment and flexible urethroscopy, was performed. Physical examinations (pad test, uroflowmetry, ultrasound) and questionnaires (I-QOL score, ICIQ-UI-SF score) were performed during baseline and during follow-up. Cure rate was defined as no pad use or one dry pad, and improved rate as 1-2 pads or reduction of pads by ≥50%.
After a median follow-up of 18.0 months (range 12-33 months, mean 18.8 months), the success rate was 50%. Daily pad use and pad weight in the 1-hour pad test decreased significantly. Patients with ICS grade 2 SUI exhibited a trend for a better success rate in comparison with patients with grade 3 and 4 SUI. Results were durable over time. Postoperatively, 16.7% of the patients exhibited transient acute urinary retention which resolved without further treatment after a maximum of 6 weeks. 1 sling had to be removed because of initial misplacement.
In selected patients after adjuvant radiotherapy, the AdVance sling achieved a success rate of 50% and results were stable in a median follow-up of 18 months. Complication rates were low and comparable to complication rates for patients without additional radiotherapy.
• To evaluate prospectively the efficacy of the retroluminar transobturator male sling (AdVance® sling) for the functional treatment of stress urinary incontinence (SUI) after prostatectomy.
• A total of 137 patients with grade II-IV SUI, resulting from radical prostatectomy, were treated with the AdVance® sling in a prospective clinical study. In all, 11 patients were lost to follow-up. A total of 17 patients (13.5%) had additional adjuvant radiotherapy before sling implantation. • Before and after sling implantation, a standardized 1-h pad test was performed and post-void residual urine, uroflowmetry, quality-of-life scores and the International Index of Erectile Function (IIEF-5) were assessed. • When calculating the cure and improvement rates, 'cure' was defined as no pad use or one dry prophylactic pad; and 'improved' was defined as 1-2 pads or reduction of pads ≥ 50%.
• After a median (range) follow-up of 27 (20-37) months, and a mean follow-up of 27.2 months, the success rate was 75.4% with 51.6%'cured' and 23.8%'improved'. • Overall daily pad use, urine loss in the 1-h pad test and quality-of-life scores improved significantly after sling implantation. • Compared with 1-year follow-up data, no worsening over time was noticed and no additional complications were seen.
• With a mid-term follow-up, the retroluminar transobturator male sling is an effective, safe and attractive treatment option for SUI after radical prostatectomy. Results are stable over time.
To evaluate the efficacy and safety of a transobturator retroluminal repositioning sling suspension in the treatment of male stress urinary incontinence (SUI) after prostate surgery.
In 118 men with SUI after prostatic surgery, a transobturator retroluminal repositioning sling suspension was implanted. Patients were evaluated including: complete history and physical examination, 24-h pad test, a questionnaire (International Consultation on Incontinence Questionnaire, Short-Form), urodynamic evaluation and endoscopy. The surgical technique was described previously. The findings before and at 1 year after sling placement were compared.
At the 12-month follow-up, 73.7% of the men were cured, 16.9% were improved, and 9.3% were still incontinent. After sling placement the daily pad use decreased significantly (P < 0.001), while the ICIQ-SF improved significantly (P < 0.01). The detrusor voiding pressure, postvoid residual urine volume and maximal flow rates remained unchanged, while the Valsalva leak-point pressure improved significantly (P < 0.01). In 19.5% of the men, there was transient scrotal pain or perineal discomfort. In 5.1% of the men, postoperative urinary retention occurred but resolved spontaneously after a few weeks of catheter placement. In 1.7% of the men adductor pain was reported, which resolved spontaneously. There were no major complications.
The transobturator retroluminal repositioning sling suspension for the treatment of male SUI is effective and safe with a low complication rate after 1 year of follow-up.
To present a prospective long-term evaluation of the bone-anchored male sling (InVance™, American Medical Systems, Minnetonka, MN, USA) for patients with moderate to severe stress urinary incontinence (SUI) after prostate surgery
Forty-five patients had a male sling implanted for SUI after prostate surgery. The evaluation before and after surgery included a complete history and physical examination, various questionnaires (American Urological Association Symptom Score, University of California Los Angeles/RAND prostate index), cysto-urethroscopy, International Continence Society (ICS) 1-h pad test and a urodynamic study. The follow-up assessments were at 2, 6 and 12 months after surgery, and yearly thereafter. The success rate was defined as the percentage of patients 'dry' and 'improved'.
The median (range) follow-up was 36 (2-64) months. Twelve patients (27%) had previous adjuvant radiotherapy. Eighteen patients (40%) had moderate SUI (two or three pads/day) and 27 (60%) had severe SUI (more than three pads/day). All preoperative ICS 1-h pad tests were positive. The success rate was 76%; 16 patients were dry (36%), 18 were improved (one or two pads/day, 40%) and in 11 the sling was a failure (24%); 76% of ICS 1-h pad tests were negative after surgery. The postoperative urodynamic study showed no signs of bladder outlet obstruction. In all, 72% of patients were satisfied/very satisfied with the surgery and 86% considered themselves cured/almost cured. The success rate was not affected by the presence of previous radiotherapy or the severity of SUI. Ten patients had perineal numbness, but in all it resolved within 1-3 months. There was one mesh infection which required its removal. There was no urethral erosion.
Compared to previous studies, the InVance male sling had a good success rate for moderate and severe SUI, with a median follow-up of 36 months. The results did not differ for moderate or severe SUI or with the presence of previous radiotherapy.
In a prospective 2-center study we confirmed and extended published results of the positive effect on post-prostatectomy stress incontinence of transobturator sling suspension using an Advance male sling.
From September 2007 to June 2008 a male sling was placed and evaluated in 36 men according to the Rehder and Gozzi method. Diagnosis was based on 24-hour urine loss measured by a pad test, a 24-hour micturition frequency volume chart and cystoscopy. A visual analog scale for continence and bother, and a pad test were used preoperatively and postoperatively to objectively evaluate operative results.
At 1-year followup cure was achieved in 9.0% of patients and improvement was achieved in 45.5%. No effect on incontinence was seen in 36.5% of patients and 9.0% experienced worsening incontinence by pad test. The mean +/- SD visual analogue scale score of 6.1 +/- 2.2 (range 0 to 10) preoperatively improved significantly to 4.6 +/- 3.0 at 3 months (p = 0.024) and not significantly to 4.9 +/- 3.1 by 1 year postoperatively (p = 0.39). Improved incontinence did not correlate with patient age or incontinence severity. Complications developed in 2 patients, including sling infection and postoperative urinary retention in 1 each.
The transobturator sling suspension operation is a minimally invasive, safe procedure for male postoperative stress incontinence. Significantly improved continence was not observed on pad test but significant improvement in continence and bother was seen on the visual analog scale at 3 months.
To evaluate prospectively the complication rate of the retrourethral transobturator sling (AdVance sling) for the functional treatment of male stress urinary incontinence (SUI).
In 230 patients with SUI due to nonintrinsic sphincter deficiency (without direct sphincter lesion) after radical prostatectomy (n=213), radical cystoprostatectomy with ileal neobladder (n=2) and transurethral resection of the prostate (n=15) a retrourethral transobturator sling was implanted. Patients were followed up for a median of 17 months (range, 4-42 months) with regard to intraoperative, early postoperative, and midterm postoperative complications.
Overall complication rate of the AdVance sling was 23.9%. Despite one accidental sling misplacement, no intraoperative complication occurred. Forty-nine patients (21.3%) experienced urinary retention postsurgery. Two slings were explanted (0.9%), 1 due to initial wrong placement and the other due to a symphysitis, attributed to a Guillain-Barré syndrome and not to a sling infection. One sling was transected (0.4%) due to slippage of the sling with obstruction of the urethra. Further complications were local wound infection (0.4%), urinary infection with fever (0.4%), and persistent moderate perineal pain (0.4%). There was no correlation between postoperative acute urinary retention and age at sling implantation, time of incontinence before sling implantation, preoperative daily pad use, or prior invasive incontinence treatment, respectively.
The retrourethral transobturator AdVance sling is a safe treatment option for male nonintrinsic sphincter deficiency SUI, with the main postoperative complication being transient acute urinary retention. Severe intra- and postoperative complications are rare and sling explantation rate is very low.
Transobturator male slings have been proposed to manage stress urinary incontinence (SUI) after prostatic surgery, but data are still lacking.
To determine the safety and prospectively evaluate the clinical outcome after management of SUI after prostatic surgery by placement of a transobturator male sling.
We conducted a prospective evaluation on 102 patients treated in a single center between 2007 and 2009 for mild to moderate SUI following prostatic surgery.
Placement of a suburethral transobturator sling and clinical follow-up.
Patients were evaluated by medical history, preoperative urodynamics, maximum flow rate measurement, 24-h pad test, and daily pad use. During follow-up, data on patients' pad use, complications, and answers to the Patient Global Impression of Improvement (PGI-I) questionnaire were collected. Cure was defined as no pad usage or one pad for security reasons and improvement as reduction of pads≥50%. Median follow-up was 13 mo (range: 6-26).
Most patients (95%) presented post-radical prostatectomy incontinence (PRPI). Hospital stay was 2 d in 97 cases, and all patients were catheterized for 24h except two (48 h). Of 102 patients, 64 were cured, 18 were improved, and 20 were not improved. According to the PGI-I questionnaire, 85%, 11%, and 4% of patients described a respectively better, unchanged, and worse urinary tract condition, respectively. Previous radiation was associated with higher rate of failure (p=0.039). Neither severe complication nor postoperative urinary obstruction was noted during follow-up.
Placement of a transobturator sling is a safe and effective procedure, giving durable results after >1 yr of follow-up. Further evaluation and high-quality controlled, randomized studies are needed to assess long-term efficacy and precise indications of this procedure for post-prostatic-surgery SUI management.
Although surgical techniques for radical prostatectomy (RP) have been refined significantly, a significant number of patients still suffer from persisting postprostatectomy stress urinary incontinence (SUI). In recent years, various minimally invasive sling systems have been investigated as treatment options for such incontinence.
The aim of the study was the prospective evaluation of the efficacy of the retrourethral transobturator sling for the functional treatment of male SUI after RP.
The study documents a single-centre prospective evaluation of the outcome of 124 patients with mild to severe SUI following RP in whom an AdVance sling was implanted between February 2006 and September 2008.
All patients were comprehensively evaluated preoperatively and after 6 mo and 1 yr regarding daily pad use, 1-h and 24-h pad tests, residual urine, uroflowmetry, Incontinence Quality of Life Scale (I-QOL) score, and Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) score. Data were collected prospectively.
After 6 mo, a cure rate (no pads or one dry security pad) of 55.8%, an improved rate (one to two pads or pad reduction≥50%) of 27.4%, and a failure rate of 16.8% were observed. After 1 yr, the cure rate was 51.4%, the improved rate was 25.7%, and the failure rate was 22.9%. Daily pad use and pad weight decreased significantly postoperatively. No significant changes were seen in residual urine and flow rate. Quality-of-life scores improved significantly. Postoperative acute urinary retention was seen in 12.9% of patients. One patient had a local wound infection that was cured with antibiotics. One patient had the sling removed due to misplacement.
The retrourethral transobturator sling is an effective and attractive treatment option for male SUI resulting from RP after 1 yr of implantation.
The ever-increasing number of radical prostatectomies entails an increasing number of patients suffering from postprostatectomy stress incontinence despite improved surgical techniques. We provide an overview of the current diagnosis and treatment of postprostatectomy stress incontinence.
To review previous and recent literature on this subject and to assess the current standards of diagnosis and management of postprostatectomy incontinence.
The PubMed database was searched, and all articles published since 2000 were evaluated.
This review presents the current recommended diagnostic tools and available noninvasive and invasive treatment options.
The European Association of Urology (EAU) recommends a two-stage assessment for diagnosis of postprostatectomy incontinence. Noninvasive therapy, pelvic floor-muscle training and biofeedback, is recommended in early postoperative and mild incontinence. Pharmacological treatment with duloxetine is especially effective in combination with physiotherapy, where it synergistically improves the continence rate. For surgical treatment, the insertion of an artificial urinary sphincter, AS-800, is still the gold standard. In recent years, several minimal invasive treatment options have been introduced with different rates of success, but they have not yet surpassed the results of the artificial sphincter.
To evaluate the efficacy and safety of the InVance bulbourethral sling in male stress urinary incontinence.
Between June 2003 and April 2005, the InVance bulbourethral sling was implanted into 50 patients with urinary incontinence after prostate surgery in 49 cases and pelvic trauma in 1 case. The patients were monitored and evaluated in a prospective manner (continence, tolerance, and satisfaction). The treatment was considered to be successful if the patient stopped wearing any kind of continence pad (patient cured) or only one pad per day (patient improved), with no de novo urinary disorders and without significant postvoid residual urine. Patient satisfaction with the procedure was assessed.
After a median follow-up of 6 mo, 50% of patients were dry, 26% had improved, and 24% suffered treatment failure. The success rates for the patients with severe incontinence and those who had undergone radiation therapy were 50% and 25%, respectively. All patients who were dry or had improved were satisfied and presented no obstructive or irritative de novo urinary disorders. The overall success rate for the 51 procedures conducted was 74.5%. Six cases of transitory acute urine retention and six cases of persistent perineal pain were reported. Explantation was necessary because of suppuration of the sling in three patients and of a de novo irritative urinary disorder in one patient. No cases of pubic osteitis or urethral erosion were reported.
The InVance bulbourethral sling procedure makes it possible to treat stress urinary incontinence after prostate surgery with satisfactory and lasting short-term results. Severe incontinence and a past history of pelvic radiation therapy seem to be factors contributing to the failure of this procedure.
We reviewed our experience with 49 consecutive patients undergoing a male sling procedure.
The 7-item International Prostate Symptom Score and 22-item incontinence quality of life questionnaire (although not validated in Italian) were used to assess the clinical impact of the bulbourethral sling. Surgical outcome was also assessed by videourodynamics at 1 year. Urodynamic success was defined as no leakage during videourodynamic evaluation.
Mean followup was 32 months (range 26 to 48). Preoperatively 3 patients used 2 pads daily (mild incontinence), 34 used 3 to 5 (moderate incontinence) and the remaining 12 used more than 5 (severe incontinence). Clinical success was defined as a decrease in pad use to completely dry (no pad) or to social continence (1 pad daily) at followup. Of the 49 patients 38 (77%), 33 (67%) and 63% (31) were considered socially continent at the 3-month, 1-year and 3-year followup, respectively. Only 15 of the 49 patients (30%) were considered completely dry at the 3-year followup. Significant perineal pain was reported in the early postoperative period but it resolved in all patients. Infection occurred in 3 patients, while no erosion was found.
The male perineal sling is a safe surgical option for post-prostatectomy urinary incontinence, especially when strict patient selection is done. Patient satisfaction is superior to urodynamic results and the procedure allows physiological voiding. Patients should be informed of the possibility of progressive failure with time and significant perineal pain in the early postoperative period.
To study the anatomical effects of placing a transobturator tape (TOT) in cadavers as well as determining the clinical outcome in men with urinary incontinence.
The study was a two stage study. The first phase was a cadaver study to examine the placement of the sling. The second part involved the placement of the sling in 20 men with incontinence, which occurred post-radical prostatectomy in 15 men. All patients had pre-operative and post-operative videourodynamics, maximum flow rate (Qmax) and residual urine measurement. Urethral pressure profiles and membranous urethral length were measured in five patients pre- and postoperatively. Incontinence was assessed on the basis of pad usage. Patients' satisfaction was recorded using a non-validated patient questionnaire at 6 weeks post-operatively.
The cadaver study revealed that a leak point pressure of 60cmH(2)O was achieved on tensioning of the tape. In the clinical series, the mean (range) urethral closure pressure improved from 13.2 (8-22) to 86.4 (70-100) cmH(2)O following placement of the TOT. The membranous urethral length increased from a mean (range) of 3 (0-7) to 17.2 (10-22) mm following tensioning of the tape. No significant differences in Qmax pre- and postoperatively were observed. Incontinence cure rate (no pad usage) was 40% and improved rate (1-2 pads per day) was 30%. The majority of patients (12/20) were very satisfied with the procedure.
The TOT, a novel procedure for treatment of post-radical prostatectomy incontinence, was shown to be effective and well accepted by patients.
To describe a new sling procedure for treating stress urinary incontinence (SUI) after radical prostatectomy (RP) and prospectively evaluate its short-term safety and efficacy.
The sling technique uses specific instruments and a polypropylene mesh with two arms that are passed inside to outside through the obturator foramens, pulled for compressing the bulbar urethra upward, and tied to each other across the midline. Patients with detrusor overactivity were excluded. Baseline and follow-up evaluations included uroflowmetry and continence and quality of life (QoL) questionnaires. Cure was defined by no pad use and improvement by a number of pads/d <or=2 and reduced by at least 50%. Complications were recorded.
From April 2006 through February 2007, 20 consecutive patients suffering from post-RP SUI underwent the sling procedure using the same operative protocol. Preoperatively, 3 (15%), 11 (55%), and 6 (25%) patients were using 2, 3-5, and >5pads/d, respectively. The procedure was preceded by an endoscopic urethrotomy in four patients. No perioperative complication was noted; three patients required suprapubic catheterization. At 6 mo, nine (45%) patients were cured and eight others (40%) were improved (1pad/d). QoL was significantly enhanced and 80% of patients were moderately to completely satisfied with the procedure. Preoperative and postoperative maximum flow rate and postvoid residual values were not statistically different. No sling infection, urethra erosion, persistent pain, or neurologic complications were observed.
The inside-out trans-obturator sling procedure appears to be safe and efficient at short term. Further studies are warranted to determine long-term outcome.
Urethral erosion of transobturator male sling
- S E Harris
- M L Guralnik
- O'connor Rc
Harris SE, Guralnik ML, O'connor RC. Urethral erosion of
transobturator male sling. Urology. 2009;73:e419-e420.
Surgery for male urinary incontinence: where are we now and what is in the pipeline?
- R Bientinesi
- S M Recupero
- G Palermo
- D 'agostino
- D Bassi
- P F Sacco
Bientinesi R, Recupero SM, Palermo G, D'Agostino D, Bassi PF, Sacco
E. Surgery for male urinary incontinence: where are we now and what
is in the pipeline? Urologia. 2015;82:139-150.
Treatment of postprostatectomy male urinary incontinence with the transobturator retroluminal repositioning sling suspension: 3-year follow-up
- P Rehder
- F Haab
- J N Cornu
- C Gozzi
- R M Bauer
Rehder P, Haab F, Cornu JN, Gozzi C, Bauer RM. Treatment of
postprostatectomy male urinary incontinence with the transobturator
retroluminal repositioning sling suspension: 3-year follow-up. Eur Urol.
2012;62:140-145.