Mohamed Abdel-Fattah

Single-incision mini-slings versus standard midurethral slings in surgical management of female stress urinary incontinence: a meta-analysis of effectiveness and complications.

CONTEXT Single-incision mini-slings (SIMS) have been introduced for the treatment of female stress urinary incontinence (SUI); however, concerns have been raised regarding their efficacy. No systematic reviews or meta-analyses have previously assessed these relatively new procedures. OBJECTIVE To assess the current evidence of effectiveness and safety of SIMS compared with standard midurethral slings (SMUS) (retropubic and transobturator tension-free vaginal tapes) in the management of female SUI. EVIDENCE ACQUISITION We conducted a literature search from 1996 to January 2011. Meta-analysis of all randomised controlled trials (RCTs) comparing SIMS versus SMUS was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Data were analysed using Rev-Man 5. Primary outcomes were patient-reported and objective cure rates. Secondary outcomes included perioperative complications, quality of life (QoL) changes, and costs to health services. EVIDENCE SYNTHESIS A total of 758 women in nine RCTs with a mean follow-up of 9.5 mo were included. The mean age (52.3 vs 52.1 yr), body mass index (27.4 vs 27.7), and parity (2.4 and 2.4) were comparable for both groups. SIMS were associated with significantly lower patient-reported and objective cure rates at 6-12 mo compared with SMUS (risk ratio [RR]: 0.83; 95% confidence interval [CI], 0.70-0.99, and RR: 0.85; 95% CI, 0.74-0.97, respectively). SIMS were associated with significantly shorter operative time (weighed mean difference [WMD]: 8.67 min; 95% CI, 17.32 to -0.02), lower day 1 pain scores (WMD: 1.74; 95% CI, -2.58 to -0.09), and less postoperative groin pain (RR: 0.18; 95% CI, 0.04-0.72). Repeat continence surgery (RR: 6.72; 95% CI, 2.39-18.89) and de novo urgency incontinence (RR: 2.08; 95% CI, 1.01-4.28) were significantly higher in the SIMS group. There was no significant difference in the QoL scores between the groups (WMD: 33.46; 95% CI, -20.62 to 87.55). No studies compared cost to health services. CONCLUSIONS SIMS are associated with inferior patient-reported and objective cure rates on the short-term follow-up, as well as higher reoperation rates for SUI when compared with SMUS.

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.

Primary and repeat surgical treatment for female pelvic organ prolapse and incontinence in parous women in the UK: a register linkage study

Objectives To determine the lifetime risk of undergoing pelvic floor surgery in a cohort of UK parous women and the re-operation rates for pelvic floor surgery, time intervals for repeat surgery and independent risk factors for undergoing primary and repeat pelvic floor surgery. Study design A register linkage study. Main outcome measures The primary outcome was lifetime risk of parous women in the UK undergoing pelvic floor surgery for pelvic organ prolapse (POP), urinary incontinence (UI), and rectal prolapse or faecal incontinence (RP-FI). Secondary outcomes were re-operation rates and time interval of repeat surgery for POP/UI, and independent risk factors for undergoing primary and repeat pelvic floor surgery. Results 34 631 women identified from the Aberdeen Maternity and Neonatal Database were linked with the Scottish Morbidity Records databases of NHS Scotland to assess relevant outcomes. The lifetime risk for women by age 80 years of undergoing any form of pelvic floor surgery was 12.2%. 2130 (6.2%) women had at least one pelvic floor surgery, of whom 407 (19%) had repeat operations. The median time intervals (IQR) between index and repeat UI and POP surgery were 2.80 (0.94–8.07) years and 3 (1.00–8.25) years, respectively. There is a reduced lifetime risk of pelvic floor surgery in women who had all deliveries by caesarean section (p<0.001) and those aged <20 years at first delivery (p=0.021). Women who sustained at least one perineal laceration (in the absence of a classified perineal tear) during delivery or who had at least one instrumental delivery with forceps use were at increased risk (p<0.001 and p=0.015, respectively). Conclusions Our study shows that in the UK more than one in 10 parous women will require at least one surgical procedure for pelvic floor disorders over their lifetime. The study also identifies independent risk and protective factors for pelvic floor surgery in parous women.

Anticholinergic Drugs for Adult Neurogenic Detrusor Overactivity: A Systematic Review and Meta-analysis

CONTEXT There is a lack of evidence about the efficacy and safety of anticholinergic drugs and about the optimal anticholinergic drug, if any, for the treatment of adult neurogenic detrusor overactivity (NDO). OBJECTIVE Review the current evidence on the efficacy, safety, and tolerability of anticholinergic drugs in the treatment of adult NDO. EVIDENCE ACQUISITION A literature search was conducted from 1966 to May 2011. Meta-analysis of all published randomised controlled trials (RCTs) comparing anticholinergic drugs with placebo and comparing different types, doses, and routes of administration of anticholinergic drugs, in adults with NDO, was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analysis statement. The primary outcome was patient-reported cure/improvement of overactive bladder symptoms. Secondary outcomes were quality of life (QoL) changes, bladder diary events, urodynamic outcomes, adverse events, and costs to health services. EVIDENCE SYNTHESIS A total of 960 patients from 16 RCTs with mean follow-up of 3.8 wk were included. Anticholinergic drugs were associated with statistically significantly better patient-reported cure/improvement (risk ratio: 2.80; 95% confidence interval [CI], 1.64 to 4.77), higher maximum cystometric capacity (weighted mean difference [WMD]: 49.49; 95% CI, 15.38 to 84.20), higher volume at first contraction (WMD: 49.92; 95% CI, 20.06 to 79.78), and lower maximum detrusor pressure (WMD: -38.30; 95% CI, -53.17 to -23.43) when compared with placebo. The dry-mouth rates were statistically significantly higher with anticholinergics, with no difference in withdrawals because of adverse events. There was no statistically significant difference in any of the outcomes between oxybutynin and other anticholinergics or among different doses and preparations of anticholinergic drugs. No study reported QoL changes or costs to health services. CONCLUSIONS Compared with placebo, anticholinergic treatment in patients with NDO is associated with better patient-reported cure/improvement and significant reduction of maximum detrusor pressure; however, there is a higher incidence of adverse events. None of the anticholinergic drugs or different dosages assessed in this review was superior to another.

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.

Surgical treatment of recurrent stress urinary incontinence in women: a systematic review and meta-analysis of randomised controlled trials

CONTEXT Recurrent stress urinary incontinence (R-SUI) represents a management dilemma; however, only a limited number of randomised controlled trials (RCTs) have assessed the various surgical procedures used for its treatment. OBJECTIVE To assess the effectiveness and complications of various surgical procedures for the treatment of female R-SUI. EVIDENCE ACQUISITION A prospective peer-reviewed protocol was prepared a priori. A systematic literature review of all published RCTs comparing surgical procedures for treatment of R-SUI was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analysis statement. Data were analysed using RevMan 5. EVIDENCE SYNTHESIS We conducted a literature search from 1945 to February 2013. Data were available for a total of 350 women in 10 RCTs with a mean follow-up of 18.1 mo. Meta-analysis was possible for the comparison of retropubic tension-free vaginal tape (RP-TVT) versus transobturator tension-free vaginal tape (TO-TVT) in five RCTs (n = 135). There was no statistically significant difference between RP-TVT and TO-TVT in the patient-reported improvement (odds ratio [OR]: 0.84, 95% confidence interval [CI], 0.41-1.69) or objective cure/improvement (OR: 1.75; 95% CI, 0.86-3.54). One RCT showed a trend towards a higher rate of patient-reported and objective cure/improvement with the inside-out TO-TVT compared with the outside-in; however, it was not statistically significant (OR: 3.00; 95% CI, 0.85-10.57, and OR: 3.32; 95% CI, 0.96-11.41, respectively). There was no significant difference between Burch colposuspension and RP-TVT (one RCT) in patient-reported improvement (OR: 0.33; 95% CI, 0.01-8.57) or objective cure/improvement (OR: 0.52; 95% CI, 0.13-2.05). CONCLUSIONS This meta-analysis shows no evidence of a significant difference in patient-reported and objective cure/improvement rates between RP-TVT and TO-TVT in the surgical treatment of women with R-SUI. However, due to the relatively low number of patients, the analysis might be underpowered. This review highlights the poor level of evidence in this field and the need for well-designed clinical trials to address this important clinical dilemma.

Consensus Statement of the European Urology Association and the European Urogynaecological Association on the Use of Implanted Materials for Treating Pelvic Organ Prolapse and Stress Urinary Incontinence

CONTEXT Surgical nonautologous meshes have been used for several decades to repair abdominal wall herniae. Implantable materials have been adopted for the treatment of female and male stress urinary incontinence (SUI) and female pelvic organ prolapse (POP). OBJECTIVE A consensus review of existing data based on published meta-analyses and reviews. EVIDENCE ACQUISITION This document summarises the deliberations of a consensus group meeting convened by the European Association of Urology (EAU) and the European Urogynecological Association, to explore the current evidence relating to the use of polypropylene (PP) materials used for the treatment of SUI and POP, with reference to the 2016 EAU guidelines (European Association of Urology 2016), the European Commissions SCENIHR report on the use of surgical meshes (SCENIHR 2015), other available high-quality evidence, guidelines, and national recommendations. EVIDENCE SYNTHESIS Current data suggest that the use of nonautologous durable materials in surgery has well-established benefits but significant risks, which are specific to the condition and location they are used for. Various graft-related complications have been described-such as infection, chronic pain including dyspareunia, exposure in the vagina, shrinkage, erosion into other organs of xenografts, synthetic PP tapes (used in SUI), and meshes (used in POP)-which differ from the complications seen with abdominal herniae. CONCLUSIONS When considering surgery for SUI, it is essential to evaluate the available options, which may include synthetic midurethral slings (MUSs) using PP tapes, bulking agents, colposuspension, and autologous sling surgery. The use of synthetic MUSs for surgical treatment of SUI in both male and female patients has good efficacy and acceptable morbidity. Synthetic mesh for POP should be used only in complex cases with recurrent prolapse in the same compartment and restricted to those surgeons with appropriate training who are working in multidisciplinary referral centres. PATIENT SUMMARY Synthetic slings can be safely used in the surgical treatment of stress incontinence in both male and female patients. Patients need to be aware of the alternative therapy and potential risks and complications of this therapy. Synthetic mesh for treating prolapse should be used only in complex cases with recurrent prolapse in specialist referral centres.

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.