A randomised comparison of single-incision versus traditional transobturator midurethral sling in women with stress urinary incontinence: results of a 24-month follow-up

Introduction and hypothesis

Midurethral sling procedures have become the principal surgical treatment for women with stress urinary incontinence (SUI). The 1-year results of this international trial comparing the efficacy and morbidity of a single-incision midurethral sling (SIMS; MiniArc) and a transobturator standard midurethral sling (SMUS; Monarc) showed that MiniArc is non-inferior regarding subjective cure and superior with regard to postoperative pain and recovery. The objective was to compare subjective and objective cure, morbidity and surgery-related discomfort following SIMS and transobturator SMUS up to a 24-month follow-up.

Methods

We carried out a non-blinded, randomised, controlled trial. Women with symptomatic SUI were eligible. Primary outcome was subjective cure, defined as an improvement on the Patient Global Impression of Improvement (PGI-I), at 12, 24 and 36 months. Secondary outcomes were objective cure based on the cough stress test, disease-specific quality of life questionnaires, surgical parameters and physical performance during recovery. Analysis was by intent to treat. Differences between the two groups regarding dichotomous variables were Chi-squared tested and presented as relative risks (RR) with corresponding 95 % confidence intervals.

Results

We randomised 97 women to MiniArc and 96 to Monarc. At the 24-month follow-up, subjective cure was 84 % following MiniArc and 89 % following Monarc (RR ?5; 95% CI ?0.17 to 0.06). Objective cure was 93 % following MiniArc and 94 % following Monarc (RR ?1; 95% CI ?0.10 to 0.07). Both procedures have low complication rates.

Conclusions

At the 2-year follow-up, the non-prespecified analysis of this randomised trial showed that the MiniArc, a single-incision sling, had similar subjective and similar objective cure rates, although non-inferiority to Monarc for subjective cure could not be demonstrated.

     

A randomized,nonblinded extension study of single-incision versus transobturator midurethral sling in women with stress urinary incontinence

Introduction and hypothesis

Midurethral sling procedures are the first surgical option in women undergoing surgery for stress urinary incontinence (SUI). Single-incision midurethral-slings (SIMS) were designed to provide similar efficacy to traditional midurethral slings but with reduced morbidity. In this international trial we compared the efficacy of a SIMS (MiniArc) and a transobturator standard midurethral sling (SMUS; Monarc) in the treatment of SUI in terms of subjective and objective cure rates and morbidity over a long-term follow-up.

Methods

This was a randomized controlled nonblinded extended trial with a follow-up period of 36 months. Women with symptomatic SUI were eligible. The primary outcome was subjective cure, defined as an improvement in the Patient Global Impression of Improvement (PGI-I) score. Secondary outcomes were objective cure (negative cough stress test), disease-specific quality of life, surgical parameters and morbidity. An intention to treat analysis was performed. Differences in dichotomous variables were tested using the chi-squared test. Differences in continuous variables were tested using Student’s t test or the Mann-Whitney U test. We hypothesized that MiniArc would be noninferior to Monarc concerning subjective cure.

Results

We randomized 97 women to the MiniArc group and 96 to the Monarc group. The attrition rate was 23% in the MiniArc group and 22% in the Monarc group after 3 years. At 36 months, the subjective cure rates were 86% in the MiniArc group and 87% in the Monarc group (risk difference ?0.6%, 95% CI ?12 to 11%). The objective cure rates were 89% and 88%, respectively (risk difference 1.3%, 95% CI ?9 to 11%). Both procedures were associated with low complication rates.

Conclusions

After a follow-up of 36 months, MiniArc (SIMS) is non-inferior to Monarc (SMUS) with respect to subjective and objective cure.

     

The Clinical Effectiveness of Retropubic (IVS-02) and Transobturator (IVS-04) Midurethral Slings: Randomized Trial

Background

Few series comparing the clinical efficacy of retropubic slings versus transobturator slings for the treatment of female stress urinary incontinence (SUI) are available.

Objective

To compare clinical efficacy of retropubic tape operations and transobturator suburethral tape operations for the surgical treatment of female SUI.

Design, setting, and participants

From January 2003 to December 2005, 611 patients underwent clinical and urodynamic evaluation before surgical treatment for SUI. Patients with advanced urogenital prolapse (pelvic organ prolapse-quantification scale [POP-Q] scale grade >1) were excluded, and 537 patients were included in this study. After 18 mo, 398 women were available for follow-up efficacy evaluation at a tertiary academic center.

Intervention

All patients underwent either a retropubic sling procedure or a transobturator sling procedure. Patients were randomly allocated into two study groups at a ratio of 1:1.

Measurements

After 18 mo all enrolled patients were clinically checked for clinical efficacy of both procedures.

Results and limitations

Demographic and urodynamic parameters of patients were similar in both groups. No bladder injury occurred in the transobturator sling group (IVS-04), whereas 13 intraoperational bladder perforations (6.5%) occurred in the retropubic sling group (IVS-02) (p < 0.001). The tape erosion rate was <2.5% in both groups (p = 0.7). After 18 mo, 398 patients (201 in the IVS-02 group and 197 in the IVS-04 group) were evaluated in terms of clinical efficacy of the procedures. We found out that there was no statistically significant difference in clinical efficacy between these two procedures (χ² = 1.88, p = 0.39). In the IVS-02 group, 75.1% of patients (n = 151) remained dry (cured), 16.9% of patients (n = 34) reported significant improvement, and 8.0% of patients (n = 16) were considered as failures. In the IVS-04 group, 74.1% of patients (n = 146) remained dry, 14.2% of patients (n = 28) reported significant improvement, and 11.7% (n = 23) were considered as failures.

Conclusions

Based on an 18-mo follow-up, the efficacies of both techniques are comparable; however, the retropubic route appears to be more efficient in the intrinsic sphincter deficiency (ISD) group.     

Complication Rates of Tension-Free Midurethral Slings in the Treatment of Female Stress Urinary Incontinence: A Systematic Review and Meta-Analysis of Randomized Controlled Trials Comparing Tension-Free Midurethral Tapes to Other Surgical Procedures and Different Devices

Objectives

To evaluate the complication rates of tension-free midurethral slings compared with other surgical treatments for stress urinary incontinence, including other tension-free midurethral slings.

Methods

A systematic review of the literature using MEDLINE, EMBASE, and Web of Science was performed in January 2007. Meta-analysis was conducted by using the Review Manager software 4.2.

Results

Our search identified 33 randomized controlled trials reporting data on complication rates. Our meta-analysis showed that complication rates were similar after tension-free vaginal tape (TVT) and Burch colposuspension, with the exclusion of bladder perforation, which was more common after TVT (p = 0.0001), and reoperation rate, which was significantly higher after Burch colposuspension (p = 0.02). TVT and pubovaginal sling were followed by similar complication rates. With regards to the comparisons among retropubic tapes, TVT and intravaginal slingplasty had similar complication rates, whereas suprapubic arc sling (SPARC) was complicated by higher rates of voiding lower urinary tract symptoms (LUTS) (p = 0.02) and reoperations (p = 0.04). Comparing retropubic and transobturator tapes, the occurrence of bladder perforations (p = 0.007), pelvic haematoma (p = 0.03), and storage LUTS (p = 0.01) was significantly less common in patients treated by transobturator tapes.

Conclusions

Tension-free slings were followed by lower risk of reoperation compared with Burch colposuspension, whereas pubovaginal sling and tension-free midurethral slings had similar complication rates. With regards to different tension-free tapes, voiding LUTS and reoperations were more common after SPARC, whereas bladder perforations, pelvic haematoma, and storage LUTS were less common after transobturator tapes. The quality of many evaluated studies was limited.     

Updated Systematic Review and Meta-Analysis of the Comparative Data on Colposuspensions,Pubovaginal Slings,and Midurethral Tapes in the Surgical Treatment of Female Stress Urinary Incontinence

Context

Burch colposuspension, pubovaginal sling, and midurethral retropubic tape (RT) and transobturator tape (TOT) have been the most popular surgical treatments for female stress urinary incontinence (SUI). Several randomized controlled trials (RCTs) have been published comparing the different techniques, with conflicting results.

Objective

Our aim was to evaluate the efficacy, complication, and reoperation rates of midurethral tapes compared with other surgical treatments for female SUI.

Evidence acquisition

A systematic review of the literature was performed using the Medline, Embase, Scopus, Web of Science databases, and Cochrane Database of Systematic Reviews.

Evidence synthesis

Thirty-nine RCTs were identified. Patients receiving midurethral tapes had significantly higher overall (odds ratio [OR]: 0.61; confidence interval [CI]: 0.46–0.82; p = 0.00009) and objective (OR: 0.38; CI: 0.25–0.57; p < 0.0001) cure rates than those receiving Burch colposuspension, although they had a higher risk of bladder perforations (OR: 4.94; CI: 2.09–11.68; p = 0.00003). Patients undergoing midurethral tapes and pubovaginal slings had similar cure rates, although the latter were slightly more likely to experience storage lower urinary tract symptoms (LUTS) (OR: 0.31; CI: 0.10–0.94; p = 0.04) and had a higher reoperation rate (OR: 0.31; CI: 0.12–0.82; p = 0.02). Patients treated with RT had slightly higher objective cure rates (OR: 0.8;CI: 0.65–0.99; p = 0.04) than those treated with TOT; however, subjective cure rates were similar, and patients treated with TOT had a much lower risk of bladder and vaginal perforations (OR: 2.5; CI: 1.75–3.57; p < 0.00001), hematoma (OR: 2.62; CI: 1.35–5.08; p = 0.005), and storage LUTS (OR: 1.35; CI: 1.05–1.72; p = 0.02). Meta-analysis demonstrated similar outcomes for TVT-O (University of Liège, Liège, Wallonia, Belgium) and Monarc (AMS, Minnetonka, MN, USA).

Conclusions

Patients treated with RT experienced slightly higher continence rates than those treated with Burch colposuspension, but they faced a much higher risk of intraoperative complications. RT and pubovaginal slings were similarly effective, although patients with pubovaginal slings were more likely to experience storage LUTS. The use of RT was followed by objective cure rates slightly higher than TOT, but subjective cure rates were similar. TOT had a lower risk of bladder and vaginal perforations and storage LUTS than RT. The strength of these findings is limited by the heterogeneity of the outcome measures and the short length of follow-up.     

The Suprapubic Arch Sling Procedure for Treatment of Stress Urinary Incontinence: A 5-Year Retrospective Study

Background

Up to now, numerous similar products concerning the surgical treatment of female stress urinary incontinence (SUI) have been developed.

Objective

To assess the long-term efficacy and safety of the suprapubic arch (SPARC) sling system in women with SUI.

Design, setting, and participants

This was a long-term retrospective study. All patients underwent a comprehensive pre- and postoperative evaluation. Forty-six women were available for clinical follow-up investigation after SPARC sling placement.

Intervention

Eighty-six women with SUI and a positive cough test underwent SPARC sling placement between June 2001 and January 2004.

Measurements

At follow-up all 46 patients underwent a cough test, a pad test, uroflowmetry, and sonographic postvoid residual volume measurement. Women rated their subjective continence status (continent, slightly incontinent, incontinent) and were asked if they would undergo the procedure again and if they would recommend it to a friend. Objective cure was defined as a pad weight 0–1 g and a negative cough test. Subjective cure was defined as no use of pads.

Results and limitations

The median follow-up was 5.2 yr. The objective cure rate was 76%; the subjective cure rate was 52%. Sixty-three percent of the patients rated themselves as continent, 33% as slightly incontinent, and 4% as severely incontinent. Most of the women (98%) would recommend the SPARC procedure to a friend and would undergo the procedure again.

Conclusions

The SPARC sling system is an effective and safe procedure for the treatment of female SUI. Patient satisfaction is independent of complete dryness.     

Five-year Results of a Randomized Trial Comparing Retropubic and Transobturator Midurethral Slings for Stress Incontinence

Background

Midurethral slings have become the most preferred surgical treatment for female urinary incontinence.

Objective

To compare the efficacy and safety of two midurethral sling procedures with a different technique of sling insertion 5 yr after intervention.

Design, setting, and participants

Multicenter randomized clinical trial conducted in seven public hospitals in Finland including primary cases of stress urinary incontinence.

Intervention

Surgical treatment with the retropubic tension-free vaginal tape (TVT) procedure or the transobturator tension-free vaginal tape (TVT-O) procedure.

Outcome measurements and statistical analysis

Objective treatment success criteria were a negative stress test, a negative 24-h pad test, and no retreatment for stress incontinence. Patient satisfaction was assessed by condition-specific quality-of-life questionnaires.

Results and limitations

A total of 95% of the included women could be assessed according to the protocol 5 yr after surgery. The objective cure rate was 84.7% in the TVT group and 86.2% in the TVT-O group, with no statistical difference between the groups. Subjective treatment satisfaction was 94.2% in the TVT group and 91.7% in the TVT-O group, with no difference between groups. Complication rates were low, with no difference between groups.

Conclusions

Both objective and subjective cure rates were >80% in both groups even when women lost to follow-up were included as failures. The complication rates were low, with no difference between the groups. No late-onset adverse effects of the tape material were seen.

Patient summary

Female urinary stress incontinence can be treated surgically with minimally invasive midurethral sling procedures. Two main approaches of sling placement have been developed: the retropubic and the transobturatory. We compared both approaches and followed the patients for 5 yr. We found no difference in cure rate between the procedures, and patient satisfaction was high.

Trial registration

ClinicalTrials.gov identifier NCT00379314.     

The AdVance Transobturator Male Sling for Postprostatectomy Incontinence: Clinical Results of a Prospective Evaluation after a Minimum Follow-up of 6 Months

Background

Transobturator male slings have been proposed to manage stress urinary incontinence (SUI) after prostatic surgery, but data are still lacking.

Objective

To determine the safety and prospectively evaluate the clinical outcome after management of SUI after prostatic surgery by placement of a transobturator male sling.

Design, setting, and participants

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.

Interventions

Placement of a suburethral transobturator sling and clinical follow-up.

Measurements

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).

Results and limitations

Most patients (95%) presented post–radical prostatectomy incontinence (PRPI). Hospital stay was 2 d in 97 cases, and all patients were catheterized for 24 h 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.

Conclusions

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.     

Prospective Evaluation of the Functional Sling Suspension for Male Postprostatectomy Stress Urinary Incontinence: Results after 1 Year

Background

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.

Objective

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.

Design, setting, and participants

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.

Measurements

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.

Results and limitations

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.

Conclusions

The retrourethral transobturator sling is an effective and attractive treatment option for male SUI resulting from RP after 1 yr of implantation.     

TVT-O for the Treatment of Pure Urodynamic Stress Incontinence: Efficacy,Adverse Effects,and Prognostic Factors at 5-Year Follow-up

Background

Inside-out tension-free vaginal transobturator tape (TVT-O) is currently one of the most effective and popular procedures for the surgical treatment of female stress urinary incontinence (SUI), but data reporting long-term outcomes are scarce.

Objective

To evaluate the efficacy and safety of TVT-O 5-yr implantation for management of pure SUI in women.

Design, setting, and participants

A prospective observational study was conducted in four tertiary reference centers. Consecutive women presenting with urodynamically proven, pure SUI treated by TVT-O were included. Patients with mixed incontinence and/or anatomic evidence of pelvic organ prolapse were excluded.

Intervention

TVT-O implantation without any associated procedure.

Outcome measurements and statistical analysis

Data regarding subjective outcomes (International Consultation on Incontinence-Short Form [ICIQ-SF], Patient Global Impression of Improvement, patient satisfaction scores), objective cure (stress test) rates, and adverse events were collected during follow-up. Multivariable analyses were performed to investigate outcomes.

Results and limitations

Of the 191 women included, 21 (11.0%) had previously undergone a failed anti-incontinence surgical procedure. Six (3.1%) patients were lost to follow-up. The 5-yr subjective and objective cure rates were 90.3% and 90.8%, respectively. De novo overactive bladder (OAB) was reported by 24.3% of patients at 5-yr follow-up. Median ICIQ-SF score significantly improved from 17 (interquartile range [IQR]:16–17) preoperatively to 0 (IQR: 0–2) (p < 0.0001).Failure of a previous anti-incontinence procedure was the only independent predictor of subjective recurrence of SUI (hazard ratio [HR]: 4.4; p = 0.009) or objective (HR: 3.7; p = 0.02). No predictive factor of de novo OAB was identified.

Conclusions

TVT-O implantation is a highly effective option for the treatment of women with pure SUI, showing a very high cure rate and a low incidence of complications after 5-yr follow-up.     

Single incision mini-sling versus a transobutaror sling: a comparative study on MiniArc™ and Monarc™ slings

Introduction and hypothesis  

A retrospective, dual-center, cohort study on the single incision MiniArc sling and the transobturator Monarc sling in the treatment of stress urinary incontinence is presented. We hypothesized that both systems would perform equally well.     

The inside-out transobturator male sling for the surgical treatment of stress urinary incontinence after radical prostatectomy: midterm results of a single-center prospective study

Background

Transobturator slings are currently promoted for the treatment of stress urinary incontinence (SUI) after radical prostatectomy (RP), but data on outcome remain limited.

Objective

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.

Design, setting, and participants

Prospective one-center trial involving 173 consecutive patients without detrusor overactivity, treated between 2006 and 2011 for SUI following RP.

Intervention

Placement of an inside-out transobturator sling.

Measurements

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.

Results and limitations

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.

Conclusions

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.     

Transobturator versus single incision slings: 1-year results of a randomized controlled trial

Introduction and Hypothesis

To compare 1-year surgical outcomes following transobturator (TO) sling placement and single incision (SI) sling placement for the treatment of stress urinary incontinence (SUI).

Methods

We performed a randomized trial at a single institution. Patients with urodynamically proven SUI were offered participation and randomized to placement of a TO sling (Monarc?) or a SI sling (MiniArc?) between 2008 and 2011. The primary outcome measure was urinary leakage during standardized cough stress test (CST). Forty subjects in each group were required to achieve 80 % power to detect an effect size of 0.25.

Results

A total of 98 patients were randomized with 49 patients in the TO group and 49 patients in the SI group. Preoperative demographics were similar between the groups (Table 1). The TO group had a significantly longer sling operative time (10.7?±?4.8 min vs. 7.8?±?4.9 min, p?<?0.001) and greater estimated blood loss (31.6?±?26.6 mL vs. 22.9?±?22.1 mL, p?=?0.02). At the 1-year follow-up, there was no difference in the primary outcome with 9 TO patients (21 %) and 12 SI patients (29 %) having a positive CST (p?=?0.5). A composite measurement of ‘failure’, defined as patient-reported SUI and a positive CST, showed no difference between the TO group (17 %) and the SI group (27 %; p?=?0.3).

Conclusions

The SI sling provides comparable objective efficacy to the TO sling at 1 year.

     

Tension-Free Vaginal Tape in the Management of Recurrent Urodynamic Stress Incontinence after Previous Failed Midurethral Tape

Background

Data about the use of tension-free vaginal tape (TVT) in the management of recurrent urodynamic stress incontinence (RUSI) after previous failed midurethral sling procedure (MUSP) are limited.

Objective

Assessment of the efficacy and the indications of the TVT procedure in the management of patients with RUSI after failed previous MUSP.

Design, setting, and participants

Thirty-one patients with RUSI after previous failed MUSP were prospectively enrolled at a single tertiary academic center.

Measurements

Preoperatively and postoperatively, patients were assessed with physical examination, urinalysis, urine culture, bladder diary for 2–3 d, Q-tip test, uroflow, filling and voiding cystometry, urethral profilometry, and 1-h pad test. Mean follow-up was at 18.6 mo (range: 12–28 mo).

Results and limitations

Overall, the objective cure rate based on the pad test findings was 74%, the improvement rate was 6.5%, and the failure rate was 19.5%. The objective cure rate based on cough stress test during filling cystometry was 77.4%, and the subjective cure rate based on patients’ answers was 71%. The study could have some limitations. The relatively small number of patients enrolled could affect the findings of study to some degree. Additionally, because urethral pressure profiles show a significant degree of directional dependence when side-hole microtip transducers are used, as in the present study, the orientation of the transducer could affect the values measured.

Conclusions

The TVT procedure as a second operation could provide an overall cure rate of 74% with a low complication rate in female patients with RUSI after previous failed midurethral tape procedures.     

Repeat Retrourethral Transobturator Sling in the Management of Recurrent Postprostatectomy Stress Urinary Incontinence After Failed First Male Sling

Background

A failure rate between 20% and 45.5% after retrourethral transobturator sling (RTS) is reported. Recommendations for the management of persistent or recurrent postprostatectomy stress urinary incontinence (SUI) after failed male sling do not exist.

Objective

The aim of this study was the prospective evaluation of the efficacy of repeat RTS (RRTS) in patients after failed first RTS.

Design, setting, and participants

Between March 2007 and August 2009, 35 patients with mild to severe SUI after failed first RTS were treated with a second AdVance sling (American Medical Systems, Minnetonka, MN, USA).

Measurements

Preoperative and postoperative evaluation included daily pad use, 1-hr pad test, postvoiding residual (PVR) urine, uroflowmetry, and quality-of-life (QoL) scores.

Results and limitations

After 6 mo, 45.5% (15 of 33 patients) showed no pad use; 30.3% (10 of 33 patients), one dry “security” pad; 3% (1 of 33 patients), one wet pad; 6.1% (2 of 33 patients), two pads; 3% (1 of 33 patients), pad reduction ≥50%; and 12.1% (4 of 33 patients), treatment failure. After 16.6 mo, 34.5% (10 of 29 patients) showed no pad use; 37.9% (11 of 29 patients), one dry “security” pad; 3.4% (1 of 29 patients), one wet pad; 3.4% (1 of 29 patients), two pads; 10.3% (3 of 29 patients), pad reduction ≥50%; and 10.4% (3 of 29 patients), treatment failure. Daily pad use and pad weight decreased significantly. PVR and uroflowmetry results showed no significant change. QoL improved significantly. Postoperative acute urinary retention was observed in 23.6% of patients.

Conclusions

RRTS is an effective and safe treatment option for the management of SUI after failed first RTS.     

Multicentre randomized trial of the Ajust™ single-incision sling compared to the Align™ transobturator tape sling

Introduction and hypothesis

Tension-free suburethral tapes have become the first-line surgical treatment for female stress urinary incontinence. Single-incision midurethral slings (SIMS) were introduced with the aim of offering similar efficacy with reduced morbidity, particularly postoperative pain. The objective of this study was to compare the effectiveness and complications of the Ajust? SIMS and the Align? transobturator tape sling.

Methods

We performed a randomized controlled trial with a noninferiority design. Women with pure stress urinary incontinence or stress-predominant mixed urinary incontinence were eligible. The primary outcome was the cure/improvement rate at 1 year, defined according to combined objective and subjective criteria. Rate differences for cure/improvement with the two procedures were calculated along with their 95% confidence intervals. The Sandvik incontinence severity index and the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) were completed before surgery and at 1 year. Complications were also reported.

Results

We randomized 30 women to the Ajust? group and 28 to the Align? group. At 1 year the cure/improvement rates were 93.3% in the Ajust? group and 96.4% in the Align? group. The rate difference for cure/improvement was of ?3.1% (95% CI ?14.4 % to 8.2%). The study was sufficiently powered to conclude the noninferiority of Ajust? SIMS under the pre-established criteria. Three women in the Ajust? group reported persistent thigh pain 1 year after surgery, but none in the Align? group reported pain.

Conclusions

At 1 year, the Ajust? SIMS showed non-inferior effectiveness compared with the Align? transobturator sling. Although not statistically significant, unexpectedly, more women reported persistent thigh pain in the Ajust? group.

     

Comparison between the retropubic and transobturator approaches in the treatment of female stress urinary incontinence: a systematic review and meta-analysis of effectiveness and complications

Objective

This study aimed to compare the effectiveness and complications between the retropubic and transobturator approaches for the treatment of female stress urinary incontinence (SUI) by conducting a systematic review.

Materials and Methods

We selected all randomized controlled trials (RCTs) that compared retropubic and transobturator sling placements for treatment of SUI. We estimated pooled odds ratios and 95% confidence intervals for intraoperative and postoperative outcomes and complications.

Results

Six hundred twelve studies that compared retropubic and transobturator approaches to midurethral sling placement were identified, of which 16 were included in our research. Our study was based on results from 2646 women. We performed a subgroup analysis to compare outcomes and complications between the two approaches. The evidence to support the superior approach that leads to better objective/subjective cure rate was insufficient. The transobturator approach was associated with lower risks of bladder perforation (odds ratio (OR) 0.17, 95% confidence interval (CI) 0.09-0.32), retropubic/vaginal hematoma (OR 0.32, 95% CI 0.16-0.63), and long-term voiding dysfunction (OR 0.32, 95% CI 0.17-0.61). However, the risk of thigh/groin pain seemed higher in the transobturator group (OR 2.53, 95% CI 1.72-3.72). We found no statistically significant differences in the risks of other complications between the two approaches.

Conclusions

This meta-analysis shows analogical objective and subjective cure rates between the retropubic and transobturator approaches to midurethral sling placement. The transobturator approach was associated with lower risks of several complications. However, good-quality studies with long-term follow-ups are warranted for further research.     

A Prospective Multicenter Randomized Comparative Study Between the U- and H-type Methods of the TVT SECUR Procedure for the Treatment of Female Stress Urinary Incontinence: 1-Year Follow-Up

Background

No studies have been published comparing the U- and H-type methods of the TVT SECUR (TVT-S) procedure.

Objective

Our aim was to compare the efficacy and safety of the two types of TVT-S for female stress urinary incontinence (SUI).

Design, setting, and participants

Women with urodynamic SUI were enrolled in this 12-mo multicenter randomized study.

Intervention

Subjects were randomly allocated to either the U- or H-type method of TVT-S.

Measurements

Pre- and postoperative evaluations included a standing stress test, the Sandvik questionnaire, the Incontinence Quality of Life (I-QOL) questionnaire, and the International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS). Patients’ satisfaction and complications were evaluated. Objective and subjective cures were defined as no leakage on the stress test and responses on the Sandvik questionnaire, respectively. We compared the surgical outcomes between the two methods.

Results and limitations

Of 285 women, 144 had the U-type method and 141 had the H-type method. Objective cure rates were 87.5% for the U-type method and 80.1% for the H-type method (p = 0.091). Subjective cure rates were 77.1% for the U-type method and 75.7% for the H-type method (p = 0.786). Improvement in I-QOL and domain scores of the ICIQ-FLUTS (filling and incontinence sum, QOL score), and patients’ satisfaction favored the U-type method. There were three cases of intraoperative vaginal wall perforation, one case of increased bleeding, and three cases of temporary postoperative retention. A power calculation was not performed, and some baseline characteristics were not balanced between the two methods.

Conclusions

Both methods of TVT-S provided comparable cure rates for female SUI. However, QOL and treatment satisfaction favored the U-type method.

Trial registration

The protocol of this study was not registered.     

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.     

41st Annual Meeting – Cape Town,South Africa August 4 – 5, 2016

Introduction and hypothesis

Stress urinary incontinence is a common problem affecting 12-46 % of women. A cohort of women have a more severe form of stress urinary incontinence usually due to intrinsic urethral sphincter deficiency that has traditionally resulted in lower success rates with standard treatment modalities. We aim to address the question of whether transobturator sling insertion is more effective than retropubic sling insertion in the treatment of intrinsic sphincter deficiency-related stress urinary incontinence in women.

Methods

We searched MEDLINE, CINAHL, CENTRAL, journals, and major conferences (up to 30 June 2014). All randomised controlled trials in women with stress urinary incontinence or mixed urinary incontinence with associated intrinsic sphincter deficiency who underwent a retropubic or transobturator mid-urethral sling operation were included in this meta-analysis. The Cochrane risk of bias tool and the GRADE system were used to assess the quality of evidence.

Results

Fifty-five randomised controlled trials compared transobturator and retropubic mid-urethral slings. Twelve trials included women with intrinsic sphincter deficiency, but only 8 trials (399 women) reported data specifically for this cohort. There was a statistically significant difference in short- and medium-term (≤5 years) subjective cure rates, with the number of women reporting a cure in the transobturator group at 150 out of 199 and the retropubic group at 171 out of 200. This gives a 12 % relative risk reduction in achieving cure with the transobturator route (RR 0.88, 95 % CI 0.80 to 0.96, I²?=?0 %, moderate quality evidence [GRADE]). Objective cure was reported by five trials of 324 women and showed no statistically significant difference between the two groups, with a rate of 110 out of 159 in the transobturator group and 126 out of 165 in the retropubic group (RR 0.90, 95 % CI 0.79 to 1.03). Post-operative voiding dysfunction and de novo urgency or urgency urinary incontinence in the two treatment groups showed no significant difference. The need to undergo repeat incontinence surgery in the long term (≥5 years) was higher with the transobturator route (RR 14.4, 95 % CI 1.95 to 106, 147 women).

Conclusions

Mid-urethral slings are effective in treating women with intrinsic sphincter deficiency-associated stress urinary incontinence. The retropubic route resulted in higher subjective cure rates compared with transobturator routes. Both routes improved the overall quality of life.