[Show abstract][Hide abstract] ABSTRACT: Objective To investigate whether uterus preserving vaginal sacrospinous hysteropexy is non-inferior to vaginal hysterectomy with suspension of the uterosacral ligaments in the surgical treatment of uterine prolapse.
Design Multicentre randomised controlled non-blinded non-inferiority trial.
Setting 4 non-university teaching hospitals, the Netherlands.
Participants 208 healthy women with uterine prolapse stage 2 or higher requiring surgery and no history of pelvic floor surgery.
Interventions Treatment with sacrospinous hysteropexy or vaginal hysterectomy with suspension of the uterosacral ligaments. The predefined non-inferiority margin was an increase in surgical failure rate of 7%.
Main outcome measures Primary outcome was recurrent prolapse stage 2 or higher of the uterus or vaginal vault (apical compartment) evaluated by the pelvic organ prolapse quantification system in combination with bothersome bulge symptoms or repeat surgery for recurrent apical prolapse at 12 months’ follow-up. Secondary outcomes were overall anatomical recurrences, including recurrent anterior compartment (bladder) and/or posterior compartment (bowel) prolapse, functional outcome, complications, hospital stay, postoperative recovery, and sexual functioning.
Results Sacrospinous hysteropexy was non-inferior for anatomical recurrence of the apical compartment with bothersome bulge symptoms or repeat surgery (n=0, 0%) compared with vaginal hysterectomy with suspension of the uterosacral ligaments (n=4, 4.0%, difference −3.9%, 95% confidence interval for difference −8.6% to 0.7%). At 12 months, overall anatomical recurrences, functional outcome, quality of life, complications, hospital stay, measures on postoperative recovery, and sexual functioning did not differ between the two groups. Five serious adverse events were reported during hospital stay. None was considered to be related to the type of surgery.
Conclusions Uterus preservation by sacrospinous hysteropexy was non-inferior to vaginal hysterectomy with suspension of the uterosacral ligaments for surgical failure of the apical compartment at 12 months’ follow-up.
Trial registration trialregister.nl NTR1866.
[Show abstract][Hide abstract] ABSTRACT: We compared cure rates and complication rates in patients who had undergone primary or recurrent (secondary) surgery for stress urinary incontinence (SUI).
A retrospective cohort study that included patients who underwent surgery to treat SUI in a tertiary referral center was carried out. All patients had, predominantly, SUI. Exclusion criteria were patients with a neurogenic bladder or a neobladder and patients without postoperative follow-up (FU). The primary objective was to assess the success rate, defined as cured SUI or improved SUI at six weeks and at the latest available moment of FU. The secondary objective was to assess complications.
A total of 541 women with SUI underwent surgery for SUI between 2002 and 2010. After exclusion of 102 patients a total of 242 patients with primary SUI and 197 patients with recurrent SUI were identified. The success rate at first FU was 89 %. At last FU (median 205 days) the success rate was 83 % (P < 0.01). There were no significant differences in success rate between primary and recurrent surgery at first FU. The overall success rate of primary surgery was 86 %; for recurrent surgery it was 79 %. During surgery, 27 bladder injuries occurred (6.2 %), with no significant difference between the two groups. At last FU, 11 patients (2.6 %) had persistent residual volume, necessitating prolonged clean intermittent self-catheterization.
The results of recurrent surgery to treat recurrent or persistent SUI are still good in experienced hands and do not significantly differ from results of primary surgery. The complication rates are comparable to those of primary surgery.
Full-text · Article · Mar 2015 · International Urogynecology Journal
[Show abstract][Hide abstract] ABSTRACT: Van de vrouwen die chirurgische behandeling voor stress urine-incontinentie (SUI) hebben ondergaan, ondergaat 8 tot 17% een tweede ingreep binnen acht tot tien jaar.
[Show abstract][Hide abstract] ABSTRACT: The rs1800255, COL3A1 2209 G>A polymorphism in the alpha 1 chain of collagen type III has been associated with an increased risk of pelvic organ prolapse (POP). In one of our previous studies however, polymerase chain reaction-based restriction fragment length polymorphism (PCR-RFLP) misdiagnosed rs1800255, COL3A1 2209 G>A in 6 % of cases. The high-resolution melting (HRM) analysis on the contrary obtained a 100 % accordance for this specific polymorphism and was used in the present study to validate this risk factor for POP.
In this case-control study, women with and without symptoms of POP were included and compared. DNA was extracted from blood samples. HRM analysis was used to assess for the presence of the homozygous rs1800255. Groups were compared using the Pearson chi-square, Mann-Whitney, and t tests. The discrepancy between HRM and PCR-RFLP results was investigated using PCR-RFLP results available from our previous study.
The study included 354 women: 272 patients with POP and 82 controls; 18 (7 %) cases versus 3 (4 %) controls had a homozygous rs1800255, COL3A1 2209 G>A polymorphism (odds ratio 1.9, 95 % confidence interval 0.5-6.9, compared to the wild type), and thus no association between POP and the homozygous polymorphism could be demonstrated. A discrepancy between HRM and PCR-RFLP results was found in 8 % of the samples.
The previously found statistically significant association between the rs1800255, COL3A1 2209 G>A polymorphism as measured with PCR-RFLP and POP could no longer be demonstrated. This raises concerns regarding the results of other association studies using PCR-RFLP.
Full-text · Article · Apr 2014 · International Urogynecology Journal
[Show abstract][Hide abstract] ABSTRACT: The objective of this study was to correlate dynamic magnetic resonance imaging (MRI) with Pelvic Organ Prolapse Quantification (POP-Q) measurements and pelvic floor symptoms in order to determine the value of dynamic MRI for evaluating vaginal vault prolapse both before and 6 months after laparoscopic sacrocolpopexy.
This was a prospective, single-center cohort study in 43 patients who underwent a modified laparoscopic sacrocolpopexy/hysteropexy operation using bone-anchor fixation and synthetic mesh. The study included dynamic MRI, POP-Q staging, and validated questionnaires before and 6 months after laparoscopic sacrocolpopexy. To assess MRI data, the pubococcygeal reference line and specifically defined anatomical landmarks for the separate compartments were used. Differences between pre- and postoperative measurements were evaluated with the Wilcoxon signed-rank test, and correlations at the 0.05 level were considered to be significant (Pearson correlation, two tailed).
At 6 months, a statistically significant improvement was seen in POP-Q staging for all compartments. Dynamic MRI measurements only revealed a significant improvement after surgery for the apical compartment. The correlation between (changes in) MRI measurements, POP-Q measurements, and validated questionnaires was poor.
The value of dynamic MRI for evaluating and documenting changes in vaginal vault support and position after laparoscopic sacrocolpopexy is limited due to the poor correlation with both POP-Q staging and pelvic floor symptoms.
No preview · Article · Oct 2013 · International Urogynecology Journal
[Show abstract][Hide abstract] ABSTRACT: OBJECTIVES: The aim of this study was to assess the inter- and intraobserver reliability for diagnosing pubovisceral muscle avulsions and measurements of the levator hiatus on magnetic resonance (MR) imaging. Women with recurrent POP or in whom there was a discrepancy between clinical signs and symptoms of pelvic floor dysfunction were potentially eligible to participate. METHODS: Magnetic resonance imaging datasets of the pelvic floor of 262 women were obtained and scored by two observers. A random sample of 100 patients was reviewed a second time by one of the observers. Intraclass correlation coefficient with 95% confidence interval (ICC 95%CI) of all measurements were calculated. Furthermore, mean differences with accompanying limits of agreement were calculated to estimate agreement between two measurements and to detect possible systematic biases. RESULTS: Good interobserver reliability for pubovisceral muscle avulsions was found (ICC 0.76 - 0.79) and excellent agreement for measurements of the levator hiatus (ICC 0.85 - 0.89). The intraobserver reliability for pubovisceral muscle avulsions and other levator hiatus measurements also showed to be excellent (ICC 0.80 - 0.97). A significant systematic bias was observed in the mean difference of levator hiatus transverse diameter when measured by both observers, however, narrow limits of agreement were observed. CONCLUSIONS: Pubovisceral muscle avulsions and levator hiatus measurements can be assessed with good to excellent reliability.
No preview · Article · Sep 2013 · Ultrasound in Obstetrics and Gynecology
[Show abstract][Hide abstract] ABSTRACT: OBJECTIVES: Despite extensive research aimed at clarifying (failing) pelvic organ support, the complete aetiology of pelvic organ prolapse (POP) is still not fully understood. During vaginal delivery, the pelvic floor can be irreversibly traumatised, resulting in pubovisceral muscle avulsions. The aetiology of these avulsions is discussed in this pictorial overview. Normal female pelvic floor anatomy is described and variations are exemplified using magnetic resonance (MR) images. The clinical relevance of detecting pubovisceral muscle avulsions is specified. METHODS: T2-weighted MR imaging has multiplanar capabilities with high diagnostic accuracy allowing for detailed visualisation of the pelvic floor. Together with the use of a three-dimensional (3D) post-processing program, the presence and severity of pubovisceral muscle avulsions can be quantified. RESULTS: Pelvic floor MR imaging is a non-invasive method that enables adequate identification of pubovisceral muscle avulsions which are known risk factors for the development of POP. They can be scored with good to excellent inter- and intra-observer reliability. CONCLUSIONS: Radiologists and urogynaecology subspecialists should be familiar with MR imaging findings of pubovisceral muscle avulsions as this birth-related trauma is observed in over 36 % of vaginally parous women. TEACHING POINTS: • Pelvic organ prolapse (POP) is a growing problem for both patients and for our healthcare system • Pubovisceral muscle avulsions are known risk factors for pelvic organ prolapse (POP) • T2-weighted MR imaging visualises pubovisceral muscle avulsions adequately • Pubovisceral muscle avulsions are scored with good to excellent inter- and intra-observer reliability.
Preview · Article · Jun 2013 · Insights into Imaging
[Show abstract][Hide abstract] ABSTRACT: Aims:
This study focused on the changes in urinary incontinence (UI) rates pre- and postoperatively and identified risk factors which predict the presence of symptoms of urgency urinary incontinence (UUI) or stress urinary incontinence (SUI) after surgery for pelvic organ prolapse (POP) without concomitant or previous anti-incontinence surgery.
All consecutive women who underwent POP surgery without concomitant or previous anti-incontinence surgery in the years 2004-2010 were included. Assessments were performed preoperatively and at 1-year follow-up, including pelvic organ prolapse quantification score and a standardized urogynecological questionnaire (Urogenital Distress Inventory, UDI). Primary outcome of this study was stress and/or urgency UI postoperatively. Furthermore, this study measured the improvement or worsening of UI following surgery using the UDI. Univariable- and multivariable logistic regression with forward selection procedure was used to identify the risk factors.
Nine hundred seven patients were included. De novo SUI appeared in 22% and de novo UUI occurred in 21% of the women. At 1-year 42% were cured for UUI and 39% were recovered from SUI by POP surgery alone. The best predictor for the occurrence of postoperative SUI or UUI was the presence of preoperative SUI or UUI. BMI and chronic obstructive pulmonary disease (COPD) were identified as independent risk factors for postoperative SUI. A recurrence in the anterior compartment protected against SUI postoperatively.
Preoperative SUI or UUI is the most important predictor of SUI and UUI postoperatively. BMI and COPD were identified as important risk factors for SUI.
Full-text · Article · Jun 2013 · Neurourology and Urodynamics
[Show abstract][Hide abstract] ABSTRACT: : To estimate whether a strategy of immediate surgery was noninferior to a strategy based on discordant urodynamic findings followed by individually tailored therapy in women with stress urinary incontinence (SUI).
: A multicenter diagnostic cohort study with an embedded noninferiority randomized controlled trial was conducted in six academic and 24 nonacademic Dutch hospitals. Women with predominant SUI eligible for surgical treatment based on clinical assessment were included between January 2009 and November 2010. All patients underwent urodynamics. In patients in whom urodynamics were discordant with clinical assessment, participants were randomly allocated to receive either immediate surgery or individually tailored therapy based on urodynamics. The primary outcome was clinical improvement assessed by the Urogenital Distress Inventory 12 months after baseline. Analysis was by intention to treat; a difference in mean improvement of 5 points or less was considered noninferior.
: Five hundred seventy-eight women with SUI were studied, of whom 268 (46%) had discordant findings. One hundred twenty-six patients gave informed consent for randomization and were allocated to receive immediate surgery (n=64) or individually tailored therapy (n=62). The mean improvement measured with the Urogenital Distress Inventory after 1 year was 44 points (±24) in the group receiving immediate surgery and 39 (±25) points in the group receiving individually tailored treatment. The difference in mean improvement was 5 points in favor of the group receiving immediate surgery (95% confidence interval -∞ to 5). There were no differences with respect to cure or complication rate.
: In women with uncomplicated SUI, an immediate midurethral sling operation is not inferior to individually tailored treatment based on urodynamic findings.
: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00814749.
Full-text · Article · May 2013 · Obstetrics and Gynecology
[Show abstract][Hide abstract] ABSTRACT: Introduction and hypothesis:
The aim of this study was to compare failure and complication rates in patients who underwent a trocar-guided vaginal mesh repair with either a non-absorbable or a partially absorbable mesh.
Retrospective analysis of prospectively collected data from consecutive women undergoing either non-absorbable or partially absorbable mesh for symptomatic stage 2 prolapse or higher were evaluated at 12 months. Outcome measures included objective and subjective failure rates, patient's satisfaction, complications and perioperative outcomes.
Five hundred and sixty-nine women (347 with non-absorbable mesh, 222 with partially absorbable mesh) were included. Failure rates were similar in the two groups; the re-operation rate in the untreated compartments was higher in the non-absorbable mesh group compared with the partially absorbable mesh group (5% vs 1%). Mesh exposure rate in the non-absorbable mesh group was 12% and in the partially absorbable mesh group it was 5%. Other complication and patient satisfaction rates were similar.
Non-absorbable and partially absorbable mesh demonstrated similar outcome rates at 12 months. The risk of reoperation was lower for partially absorbable mesh. The mesh exposure rate was significantly lower for the partially absorbable mesh group compared with the non-absorbable mesh group.
Full-text · Article · May 2013 · International Urogynecology Journal
[Show abstract][Hide abstract] ABSTRACT: Introduction and hypothesis:
The objective of this work was to collect and summarize a detailed historical review of the surgical treatment of pelvic organ prolapse (POP) in which we specifically focused on the anterior compartment.
A literature search in English, Dutch, and German was carried out using the keywords pelvic organ prolapse, anterior colporrhaphy, cystocele, and interposition operations in several databases (e.g., PubMed and HathiTrust Digital Library). Other relevant journal and textbook articles were found by retrieving references cited in previous articles and textbooks.
Probably the first explanation of the treatment of POP dates from 1500 B.C. The Egyptians gave a description to "falling of the womb" in the Kahun Papyrus. More than a millennium later, Euryphon, a contemporary of Hippocrates (400 B.C.) described some interesting therapeutic options, from succussion (turning a women upside down for several minutes) to irrigating the displaced uterus with wine. A wide range of techniques has been attempted to repair the prolapsing anterior vaginal wall. By 1866, Sim had already performed a series of operations very similar to a modern anterior repair. The first reviews about the abdominal approach to correcting a cystocele were in 1890. The first description of using mesh to cystoceles was the use of tantalum mesh in 1955. In 1970, the first report of collagen mesh in urogynecology was described. Nowadays, robot-assisted surgery and cell-based tissue engineering are the latest interventions.
Many surgeons have tried to find the ideal surgical therapy for anterior compartment prolapse, but to date, this has not been achieved.
Full-text · Article · Mar 2013 · International Urogynecology Journal
[Show abstract][Hide abstract] ABSTRACT: Objective:
To evaluate the difference in thickness of the anterior vaginal wall removed after different surgical dissecting techniques of anterior colporrhaphy.
In patients undergoing primary anterior colporrhaphy, trimmed vaginal tissue was taken following different surgical techniques of vaginal wall dissection. Tissues were preserved in formalin and stained with hematoxylin-eosin and elastica-van Giesen stains. The examiner was an experienced pathologist blinded to the surgical technique. The specimens were examined for the epithelial thickness (ET), lamina propria thickness (LPT), muscular layer thickness (MT) and total thickness (TT).
Tissue was analysed in 93 women who underwent anterior compartment pelvic organ prolapse surgery. There was no difference between the different surgical techniques in thickness measured in the three histological layers and for the total thickness. The use of hydrodissection was the only independent factor leading to thicker removed vaginal tissue.
Dissecting the vaginal wall as thin as possible does not result in a thinner vaginal layer than dissecting in the most optimal surgical plane. The use of hydrodissection provides a thicker trimmed tissue.
No preview · Article · Jan 2013 · European journal of obstetrics, gynecology, and reproductive biology
[Show abstract][Hide abstract] ABSTRACT: The value of urodynamics (UDS) in the preoperative workup of women with complaints of stress urinary incontinence (SUI) is in question. A previous underpowered randomized controlled trial (RCT) by the same group compared a strategy of UDS and a strategy of immediate surgery in the preoperative workup of women with SUI. Those data showed no benefit of UDS in these women. This multicenter cohort study was designed to determine whether a strategy of immediate surgery is noninferior to a strategy based on urodynamic findings followed by individually tailored therapy in women with SUI. The study was conducted at 6 academic and 24 nonacademic hospitals in the Netherlands between January 2009 and November 2010. All participants enrolled in the study had predominant SUI and were candidates for surgical treatment based on clinical assessment. All subjects underwent UDS according to International Continence Society standards. The primary study outcome was clinical improvement as measured with the Urogenital Distress Inventory (UDI) at 1 year after baseline. A difference in mean improvement of 5 points or less in the UDI urinary incontinence subscale score was considered noninferior. Among 578 women included in the intention-to-treat analysis, 268 (46%) had urodynamic findings discordant with clinical history and physical examination. Study subjects with discordant UDS who consented to take part in a nested randomized trial received either immediate surgery (n = 64) or individually tailored therapy based on UDS (n = 62). After 1 year, the mean improvement measured on the UDI was 44 points (±24) in the group receiving immediate surgery and 39 (±25) points in the group receiving individually tailored treatment. The 5-point difference in mean improvement in the group receiving immediate surgery confirms noninferiority for either 1 of both treatment strategies. The mean improvement of the randomized subjects was also not different from those of the cohort of women for whom UDS was concordant with their clinical diagnosis of SUI. There were no differences between all groups with respect to subjective or objective cure or in the complication rate. These findings show that an immediate midurethral sling operation in women with uncomplicated SUI is not inferior to individually tailored treatment based on urodynamic findings. The data suggest that UDS can be omitted before stress incontinence surgery in women with uncomplicated SUI.
Full-text · Article · Jan 2013 · Obstetrical and Gynecological Survey