Alyaa Mostafa

Single-Incision Mini-Slings Versus Standard Midurethral Slings in Surgical Management of Female Stress Urinary Incontinence: An Updated Systematic Review and Meta-analysis of Effectiveness and Complications

CONTEXT An updated systematic review and meta-analysis of randomised controlled trials (RCTs) comparing single-incision mini-slings (SIMS) versus standard midurethral slings (SMUS) in the surgical management of female stress urinary incontinence (SUI). OBJECTIVE To evaluate the clinical efficacy, safety, and cost effectiveness of SIMS compared with SMUS in the treatment of female SUI. EVIDENCE ACQUISITION A literature search was performed for all RCTs and quasi-RCTs comparing SIMS with either transobturator tension-free vaginal tape (TO-TVT) or retropubic tension-free vaginal tape (RP-TVT). The literature search had no language restrictions and was last updated on May 2, 2013. The primary outcomes were patient-reported and objective cure rates at 12 to 36 mo follow-up. Secondary outcomes included operative data; peri- and postoperative complications, and repeat continence surgery. Data were analysed using RevMan software. Meta-analyses of TVT-Secur versus SMUS are presented separately as the former was recently withdrawn from clinical practice. EVIDENCE SYNTHESIS A total of 26 RCTs (n=3308 women) were included. After excluding RCTs evaluating TVT-Secur, there was no evidence of significant differences between SIMS and SMUS in patient-reported cure rates (risk ratio [RR]: 0.94; 95% confidence interval [CI], 0.88-1.00) and objective cure rates (RR: 0.98; 95% CI, 0.94-1.01) at a mean follow-up of 18.6 mo. These results pertained on comparing SIMS versus TO-TVT and RP-TVT separately. SIMS had significantly lower postoperative pain scores (weighted means difference [WMD]: -2.94; 95% CI, -4.16 to -1.73) and earlier return to normal activities and to work (WMD: -5.08; 95% CI, -9.59 to -0.56 and WMD: -7.20; 95% CI, -12.43 to -1.98, respectively). SIMS had a nonsignificant trend towards higher rates of repeat continence surgery (RR: 2.00; 95% CI, 0.93-4.31). CONCLUSIONS This meta-analysis shows that, excluding TVT-Secur, there was no evidence of significant differences in patient-reported and objective cure between currently used SIMS and SMUS at midterm follow-up while associated with more favourable recovery time. Results should be interpreted with caution due to the heterogeneity of the trials included.

Prospective multi-centre study of adjustable single-incision mini-sling (Ajust®) in the management of stress urinary incontinence in women: 1-year follow-up study

Study Type – Therapy (individual cohort)

Prospective Randomised Controlled Trial of Transobturator Tapes in Management of Urodynamic Stress Incontinence in Women: 3-Year Outcomes from the Evaluation of Transobturator Tapes Study

BACKGROUND There is a lack of information on the long-term outcomes of transobturator tension-free vaginal tape (TO-TVT) in the surgical treatment of female stress urinary incontinence (SUI). OBJECTIVES To assess the 3-yr outcomes following TO-TVT and to compare the effectiveness of inside-out versus outside-in approaches. DESIGN, SETTING, AND PARTICIPANTS A 3-yr follow-up study of the Evaluation of Transobturator Tapes (E-TOT) trial, a randomised controlled trial (RCT) conducted with women undergoing TO-TVT as a sole procedure between April 2005 and April 2007 in a tertiary urogynaecology centre in the United Kingdom. INTERVENTION Patients (n=341) were randomised to undergo either TVT-O (Ethicon Inc., Somerville, NJ, USA) for the inside-out approach or TOT-Aris (Coloplast Corp., Minneapolis, MN, USA) for the outside-in approach. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The primary outcome was patient-reported success rate. Secondary outcomes included further treatment for SUI, improvement in quality of life, late complications, and risk factors for late failures. Categorical variables were compared using the chi-square or Fisher exact test. Within-group comparison was undertaken using Wilcoxon and Mann-Whitney tests. Risk factors for late failures were assessed in a multivariate regression model. All statistical analysis was performed using SPSS v.18.0 (IBM Corp., Armonk, NY, USA). RESULTS AND LIMITATIONS The 3-yr follow-up was completed by 238 of the 341 women (70%). The overall success rate, based on Patients Global Impression of Improvement response, was 73.1%, with no significant difference between the inside-out and the outside-in TO-TVT (73.18% vs 72.3%; odds ratio: 0.927; 95% confidence interval, 0.552-1.645; p=0.796). Compared with the 1-yr follow-up, there was a significant reduction in the patient-reported success rate (p=0.005); however, no independent risk factors were identified. A clinically significant improvement (≥10 points) was seen in 80% (n=191) of women, with no significant difference between both groups (p=0.113). Twenty-two women (6%) underwent further surgical treatment within 3 yr. The lack of an objective outcome assessment is a potential limitation of this RCT. CONCLUSIONS The E-TOT RCT showed a 73% patient-reported success rate for TO-TVT at 3-yr follow-up, with no significant differences between inside-out and outside-in approaches. There was a significant drop in patient-reported success rates between 1 and 3 yr.

A multicentre prospective randomised study of single-incision mini-sling (Ajust®) versus tension-free vaginal tape-obturator (TVT-O™) in the management of female stress urinary incontinence: pain profile and short-term outcomes.

OBJECTIVES To compare the postoperative pain profile, peri-operative details, and short-term patient-reported and objective success rates of single-incision mini-slings (SIMS) versus standard mid-urethral slings (SMUS). STUDY DESIGN In a multicentre prospective randomised trial in six UK centres in the period between October 2009 and October 2010, 137 women were randomised to either adjustable SIMS (Ajust®, C. R. Bard Inc., NJ, USA), performed under local anaesthesia as an opt-out policy (n=69), or SMUS (TVT-O™, Ethicon Inc., Somerville, USA) performed under general anaesthesia (n=68). Randomisation was done through number-allocation software and using telephone randomisation. Postoperative pain profile (primary outcome) was assessed on a ten-point visual analogue scale at fixed time-points. Pre- and post operatively (4-6 months) women completed symptom severity, urgency perception scale (UPS), quality of life and sexual function questionnaires. In addition, women completed a Patient Global Impression of Improvement Questionnaire and underwent a cough stress test at 4-6 months follow up. Sample size calculation was performed and data were analysed using SPSS 18. Descriptive analyses are given and between-group comparisons were performed using chi-square, Fischer exact test and Mann-Whitney test as appropriate. Significance level was set at 5%. RESULTS Women in the SIMS Ajust® group had a significantly lower postoperative pain profile up to 4 weeks (p=<0.001, 95% CI 1.151, 2.480). There was no significant difference in peri-operative complications between groups. All 137 women completed the 4-6 months follow-up. Patient-reported and objective cure rates were not significantly different: 85.5% versus 91.2% (p=0.443) and 90% versus 97% (p=0.165) between the SIMS Ajust® and TVT-O™ groups respectively. There was a trend towards higher rates of de novo urgency or worsening of pre-existing urgency in the SIMS Ajust® group (21.7% versus 8.8%) but this did not reach statistical significance (p=0.063). Women in the SIMS Ajust® group had shorter hospital stay (median (IQR) 3.65 (2.49, 4.96)) compared to (4.42 (3.16, 5.56)) the TVT-O™ group 95% CI (-0.026, 1.326), with significantly earlier return to normal activities (p=0.025) and to work (p=0.006). CONCLUSION The adjustable single-incision mini-sling (Ajust®) is associated with a significantly improved postoperative pain profile and earlier return to work when compared to standard mid-urethral slings (TVT-O™), with encouraging results in patient-reported and objective success rates at short-term follow-up.

Evaluation of Transobturator Tension-Free Vaginal Tapes in the Surgical Management of Mixed Urinary Incontinence: 3-Year Outcomes of a Randomized Controlled Trial

PURPOSE We evaluate the clinical effectiveness of transobturator tension-free vaginal tape procedures in the surgical management of mixed urinary incontinence in women at 3-year followup. MATERIALS AND METHODS In this secondary analysis of a prospective, single-blind, randomized controlled trial 83 of 341 women (24%) with mixed urinary incontinence were randomized to undergo an outside-in (Aris® transobturator sling system 42) or inside-out (TVT™-O 41) transobturator tension-free vaginal tape procedure. Patients were contacted by postal questionnaire at a minimum of 3 years postoperatively. The primary outcome was the patient reported success rate, defined as very much improved/much improved on the PGI-I (Patient Global Impression of Improvement). Secondary outcomes included improvement in quality of life, impact on preoperative urgency/urgency incontinence and repeat surgical treatment for stress urinary incontinence. Outcomes at 3 years were compared between groups (outside-in vs inside-out) and to 1-year outcomes. Analysis was performed using SPSS® version 20 with significance levels set at p = 0.05. RESULTS A total of 66 women with mixed urinary incontinence completed the 3-year followup (outside-in 35 vs inside-out 31). In each group 2 women underwent further continence surgery. The patient reported success rate was 73.8% with no significant differences between the groups (OR 1.035, 95% CI 0.342-3.134, p = 0.951). Overall 34 (50.1%) and 26 women (56.5%) reported cure of preoperative urgency and urgency incontinence, respectively, and 52 women (86.7%) had a clinically significant improvement in quality of life (18 points or more in total KHQ [Kings Health Questionnaire] score) compared to baseline. CONCLUSIONS Transobturator tape procedures are associated with a good (73.8%) patient reported success rate at a minimum of 3 years of followup in the surgical management of mixed urinary incontinence in women with predominant stress urinary incontinence symptoms. Nearly half of the women reported cure of urgency/urgency incontinence.

Preoperative urodynamic predictors of short‐term voiding dysfunction following a transobturator tension‐free vaginal tape procedure

To determine whether preoperative urodynamic parameters can predict the development of short‐term voiding dysfunction (VD) after a transobturator tension‐free vaginal tape (TO‐TVT) procedure.

Preoperative determinants for failure of transobturator tapes in the management of female urodynamic stress incontinence

To determine significant preoperative risk factors for failure of transobturator tapes.

Comparison of an adjustable anchored single-incision mini-sling, Ajust(®) , with a standard mid-urethral sling, TVT-O(TM) : a health economic evaluation.

To assess the cost, quality of life (QoL) and cost‐effectiveness of a single‐incision mini‐sling (SIMS; Ajust®, C. R. Bard Inc., New Providence, NJ, USA) compared with a standard mid‐urethral sling (SMUS; TVT‐O™, Ethicon Inc., Somerville, NJ, USA) in the surgical management of female stress urinary incontinence.

Long‐term outcomes of transobturator tapes in women with stress urinary incontinence: E‐TOT randomised controlled trial

To assess the long‐term patient‐reported outcomes and adverse events following surgery using transobturator tension‐free vaginal tape (TO‐TVT).

Factors Influencing Women's Decision to Participate or Not in a Surgical Randomised Controlled Trial for Surgical Treatment of Female Stress Urinary Incontinence

The study aims to explore the potentially influential factors affecting womens decision to accept/decline participation in surgical randomised trial using a novel acceptance/refusal questionnaire (ARQ). All women who were eligible to participate in SIMS-RCT were asked to complete the relevant section (acceptance/refusal) of the ARQ. Women reported its degree of relevance for their decision on a six-point Likert scale (0 = highly irrelevant, 5 = highly relevant). 135 (98%) and 31 (70%) women completed the acceptance and refusal sections of the ARQ, respectively. The most influencing factor in womens acceptance was the anticipation of “potential personal benefit”; percentage of relevance (POR) was 91.9%, followed by interest in helping others by “supporting innovative medical research”; POR was 87.7%. Most influencing factor in refusal for participation was “do not have time for follow-up”; POR was 56.8%, followed by “do not like the concept of randomisation”; POR was 54.4%. In conclusion, this study identifies the most influential factors relevant to women decision-making whether or not to participate in RCTs assessing surgical interventions for female stress urinary incontinence (SUI). A number of factors leading to refusal of participation are potentially correctable leading to better recruitment rates in future RCTs.