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.     

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.     

Tension-Free Vaginal Tape Versus Transobturator Suburethral Tape: Five-Year Follow-up Results of a Prospective,Randomised Trial

Background

Many studies have assessed the equivalent effectiveness of tension-free vaginal tape (TVT) and transobturator suburethral tape (TVT-O) at short- to medium-term follow-up, but no long-term randomised trials appear in the literature.

Objective

We compared the use of TVT to TVT-O, providing a longer follow-up than currently appears in the literature.

Design, setting, and participants

Seventy-two consecutive patients affected by stress urinary incontinence (SUI) were included in this randomised, controlled trial. Patients were randomly allocated to the TVT or TVT-O procedure using a predetermined, computer-generated randomisation code.

Intervention

After preoperative assessment, patients were randomly allocated to the TVT or TVT-O procedure.

Measurements

This 5-yr study represents the extension of our original randomised trial, which was designed to assess the incidence of long-term complications (primary end point) and successes (secondary end point) for both techniques.

Results and limitations

At 60-mo follow-up, 52 patients (72%) were objectively cured of SUI (72.9% after TVT-O and 71.4% after TVT), but only 44 patients (61%) were satisfied. The late complication rate was 16.6% (10 women): five women (16.1%) in the TVT-O group and five women (17.2%) in the TVT group (p = 1). In this follow-up, 62% of the patients from the TVT-O group and 60% from the TVT group (p = 1) expressed that they were satisfied or very satisfied with the results. The mean cause of dissatisfaction was the development of sexual dysfunction resulting from dyspareunia or incontinence during intercourse, which was found in 6 of 16 dissatisfied patients (37.5%). The limitations of our study included the adequate but small sample size and the lack of questionnaires.

Conclusions

Both surgical techniques are safe, with similar results (72.9% and 71% of patients objectively cured after TVT-O and TVT, respectively) and low complication rates (16.6%: 16.1% and 17.2%, respectively, for TVT-0 and TVT), even after 5-yr follow-up.     

Tension-free vaginal tape for the treatment of urodynamic stress incontinence: efficacy and adverse effects at 10-year follow-up

Background

One of the most effective and popular current procedures for the surgical treatment of stress urinary incontinence (SUI) is tension-free midurethral slings.

Objective

To evaluate the outcomes of women with retropubic tension-free vaginal tape (TVT) for urodynamic stress incontinence (USI) after 10-yr follow-up.

Design, setting, and participants

This was a prospective observational study. Consecutive women with proven USI were treated with TVT. Patients with mixed incontinence and/or anatomic evidence of pelvic organ prolapse were excluded.

Intervention

Standard retropubic TVT.

Measurements

Patients underwent preoperative clinical and urodynamic evaluations. During follow-up examinations, women were assessed for subjective satisfaction and objective cure rates. Multivariable analyses were performed to investigate outcomes.

Results and limitations

A total of 63 women were included. After 10 yr, 5 patients (8%) were lost or no longer evaluable. The 10-yr subjective, objective, and urodynamic cure rates were 89.7%, 93.1%, and 91.4%, respectively. These rates were stable across the whole study period (p > 0.99). De novo overactive bladder was reported by 30.1% and 18.9% of patients at 3-mo and 10-yr follow-up, respectively (p for trend = 0.19). A total of 84.2% of women with detrusor overactivity received antimuscarinic drugs, but 43.8% were nonresponders 12 wk later. At multivariable analysis, maximum detrusor pressure during the filling phase >9 cm H₂O (hazard ratio [HR]: 16.2; p = 0.01) and maximum detrusor pressure during the voiding phase ≤29 cm H₂O (HR: 8.0; p = 0.01) were independent predictors for the recurrence of SUI, as well as obesity was for the recurrence of objective SUI (HR: 17.1; p = 0.01) and of USI (HR: 8.9; p = 0.02), respectively. Intraoperatively, bladder perforation occurred in two cases; no severe bleeding or other complications occurred.

Conclusions

The 10-yr results of this study seem to demonstrate that TVT is a highly effective option for the treatment of female SUI, recording a very high cure rate with low complications after a 10-yr follow-up.     

Management of recurrent stress urinary incontinence and urinary retention following midurethral sling insertion in women

INTRODUCTION

Synthetic midurethral slings are the most common operations performed for women with stress urinary incontinence (SUI). However, there is only very scarce evidence regarding the management of complications from these operations. The aim of this survey was to canvass expert opinion regarding the management of recurrent SUI and urinary retention following insertion of these slings.

METHODS

Expert urologists and urogynaecologists in the UK with an interest in SUI were identified. Three clinical scenarios on recurrent SUI and one on urinary retention following midurethral sling placements were emailed twice to the experts.

RESULTS

The majority of the experts chose a repeat synthetic midurethral retropubic transvaginal tape (TVT) as the procedure of choice for recurrent SUI in patients who had had a previous TVT or midurethral transobturator tape inserted. In patients who continued to suffer SUI after a failed second TVT, there were mixed results with experts choosing fascial slings, colposuspension and bulking agents as their preferred method of treatment. In women who develop urinary retention following a TVT, tape pull-down within two weeks was the preferred method among the experts. However, division of the tape within two to six weeks following the procedure was also popular.

CONCLUSIONS

Based on expert opinion, it is difficult to make a recommendation as to the best method of treating recurrent SUI or urinary retention following tape insertion. There is an urgent requirement for well conducted, multicentre, randomised clinical trials to look at the management of these complications and also the tools used to assess the patient before salvage surgical management.     

Exploratory study assessing efficacy and complications of TVT-O, TVT-Secur, and Mini-Arc: results at 12-month follow-up

Background

Contemporary surgical treatment of female stress urinary incontinence (SUI) includes retropubic and transobturator (TO) midurethral slings (MUS). Case series of single-incision slings (SIS) have shown similar outcomes with lower morbidity.

Objective

Our aim was to assess the cure rates, complications, and quality-of-life impact of one standard TO MUS and two SIS.

Design, setting, and participants

Ninety consecutive patients with clinically and urodynamically proven SUI were enrolled in an exploratory randomised phase 2 trial. Patients with previous SUI surgery, major pelvic organ prolapse, mixed incontinence, or detrusor overactivity were excluded.

Interventions

Patients were treated randomly with TVT-O, TVT-Secur, or Mini-Arc.

Measurements

Postoperative visits were scheduled at 6 and 12 mo. The King's Health Questionnaire (KHQ) was repeated at 6 mo. Cure was defined as the absence of urine leakage, no pad use, and a negative cough test at 12 mo. Pain and other complications were also investigated.

Results and limitations

Cure rate was 83% after TVT-O, 67% after TVT-Secur, and 87% after Mini-Arc. Improvement was found in 10%, 13%, and 7% of the patients, respectively. Failures were 7% after TVT-O and Mini-Arc and 20% after TVT-Secur.TVT-O and Mini-Arc improved at least 15 points in >80% of the patients in six KHQ domains, whereas TVT-Secur could only achieve improvement in three of the nine domains. The pain score was lower in the Mini-Arc group. Complications were more numerous after TVT-O. This study has the limitations inherent in a phase 2 trial with a follow-up limited to 12 mo.

Conclusions

Mini-Arc offers cure and improvement rates similar to TVT-O, whereas TVT-Secur may yield an inferior outcome. These findings recommend the urgent launch of large randomised phase 3 studies comparing conventional MUS with SIS, with Mini-Arc the advised option.     

Pelvic organ prolapse surgery with and without tension-free vaginal tape in women with occult or asymptomatic urodynamic stress incontinence: a randomised controlled trial

Introduction

We set out to determine if insertion of a retropubic tension-free vaginal tape (TVT) sling at the time of pelvic organ prolapse surgery improves continence outcomes in women with pre-operative occult stress incontinence (OSI) or asymptomatic urodynamic stress incontinence (USI).

Methods

We conducted a randomised controlled study of prolapse surgery with or without a TVT midurethral sling. The pre- and post-operative assessment at 6 months included history, physical examination and urodynamic testing. Quality of life (QOL) and treatment success was assessed with the UDI-6 SF, IIQ-7 SF and a numerical success score. The primary outcome was symptomatic stress urinary incontinence (SUI) requiring continence surgery (TVT) at 6 months. Long-term follow-up continued to a minimum of 24 months. Secondary outcomes were quality of life parameters.

Results

Eighty women received prolapse surgery alone (n?=?43) or prolapse surgery with concurrent TVT (n?=?37). Six months following prolapse surgery 3 out of 43 (7 %) patients in the no TVT group requested sling surgery compared with 0 out of 37 (0 %) in the TVT group (ARR 7 % [95 %CI: 3 to 19 %], p?=?0.11). After 24 months there was one further participant in the no TVT group who received a TVT for treatment of SUI compared with none in the TVT group (4 out of 43, 9.3 % versus 0 out of 37; ARR 9.3 % [95 %CI: ?1 to 22 %], p?=?0.06). Both groups showed improvement in QOL difference scores for within-group analysis, without difference between groups.

Conclusion

These results support a policy that routine insertion of a sling in women with OSI at the time of prolapse repair is questionable and should be subject to shared decision-making between clinician and patient.     

De novo overactive bladder following midurethral sling procedures: a systematic review of the literature and meta-analysis

Introduction and hypothesis

De novo overactive bladder (OAB) is a known complication of midurethral sling surgery for the treatment of stress urinary incontinence. To date, differences in the incidence of de novo OAB following the use of different types of midurethral sling remain relatively unknown. The purpose of the present systematic review was to evaluate this incidence and summarize current evidence.

Methods

We systematically searched the literature using the MEDLINE, Embase, Scopus, ClinicalTrials.gov, LILACS and Cochrane Central Register of Controlled Trials databases as well as the grey literature and references from the electronically retrieved articles. For comparisons of proportions, we used the chi-squared test. All reported analyses were designed as two-tailed. Statistical significance was set at p < 0.05.

Results

Finally, 32 studies were included in this systematic review, with a total of 3,139 patients who had undergone midurethral sling procedures that included transobturator tapes (TOT), retropubic tapes (TVT) or single-incision tapes (mini-slings). The overall incidence of de novo OAB was 11.5% in nonrandomized studies (280 women) and 6.4% in randomized studies (50 women). In relation to the type of midurethral sling, the incidence of de novo OAB was 9.7% for mini-slings, 11.2% for TVT-O, 8.7% for TOT and 9.8% for TVTs. The chi-squared test did not reveal significant differences (p = 0.58).

Conclusions

Current evidence suggests that the overall incidence of de novo OAB following midurethral sling procedures is approximately 9%. There is not enough evidence to support differences in the effects of the different types of sling with regard to this particular postoperative complication.

     

Patient satisfaction after retropubic and transobturator slings: first assessment using the Incontinence Outcome Questionnaire (IOQ)

Introduction and hypothesis

The aim of the Incontinence Outcome Questionnaire (IOQ) is to assess quality of life and patient-reported outcome after midurethral slings.

Methods

In this retrospective study, 626 patients with a minimum follow-up period of 1?year were sent the IOQ. Four hundred twenty-two of 626 (67.4%) patient responses were evaluated.

Results

The mean IOQ QoL extended score was 33.7?±?17.5 and comparable for tension-free vaginal tape (TVT), outside-in transobturator tape (TOT), and inside-out transobturator vaginal tape (TVT-O). Evaluation of IOQ question about readmission revealed a total of 32 patients (18 TVT, 12 TOT, and 2 TVT-O) who underwent a subsequent operation due to sling-related complications. Freedom from reoperation for recurrent SUI at 1, 2, and 5?years was 100%, 99.7?±?0.3%, and 99.7?±?0.3% for TVT, 100% for TVT-O, and 94.2?±?2.5%, 91.9?±?2.9%, and 89.9?±?3.5% for TOT, respectively (p?<?0.001).

Conclusions

Patient satisfaction, assessed using the IOQ, is high after retropubic and transobturator slings. In our collective, relapse incontinence is higher after TOT.     

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.

     

Female urinary incontinence: patient-reported outcomes 1?year after midurethral sling operations

Introduction and hypothesis

Although midurethral slings have become standard surgical methods to treat stress urinary incontinence (SUI), little is known about women who still have urinary incontinence (UI) after surgery. This study assesses and compares the patient-reported outcome 12?months after tension-free vaginal tape (TVT), tension-free vaginal tape-obturator (TVT-O), and transobturator tape (TOT), with a special focus on women who still have urinary leakage postoperatively.

Methods

This study analyzed preoperative and 12-month postoperative data from 3,334 women registered in the Swedish National Quality Register for Gynecological Surgery.

Results

Among the women operated with TVT (n?=?2,059), TVT-O (n?=?797), and TOT (n?=?478), 67?%, 62?%, and 61?%, respectively, were very satisfied with the result at the 1-year follow-up. There was a significantly higher chance of becoming continent after TVT compared with TOT. In total, 977 women (29?%) still had some form of urinary leakage postoperatively. Among the postoperatively incontinent women who expressed a negative impact of UI on family, social, work, and sexual life preoperatively, considerably fewer reported a negative impact in all domains after surgery. Of those in the postoperatively incontinent group who had coital incontinence preoperatively, 63?% reported a cure of coital incontinence.

Conclusions

The proportion of women very satisfied with the result of the operation did not differ between the three groups. TVT had a higher SUI cure rate than did TOT. Despite urinary leakage 1-year postoperatively, half of the women were satisfied with the result of the operation.     

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 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.     

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.     

Retropubic vs. transobturator tension-free vaginal tape for female stress urinary incontinence: 3-month results of a randomized controlled trial

Background

We conducted a prospective randomized controlled noninferiority trial to compare objective and subjective outcomes of retropubic tension-free vaginal tape (TVT) with those of transobturator tape (TVT-O) as primary treatment for stress urinary incontinence (SUI) in women.

Study design

The study was conducted at 25 gynecology units in Austria and Germany; regional and academic hospitals participated. A total of 569 patients were randomly assigned to undergo TVT or TVT-O.

Results

A total of 480 patients (85 %) were examined at 3 months. A negative cough stress test with stable cystometry to 300 ml was seen in 87 % of patients after TVT and in 84 % after TVT-O; 64 % and 59 % of patients, respectively, reported no pad use, and 88 % of patients in both groups considered themselves much or very much better on the Patient Global Impression of Improvement (PGI-I) scale. Quality of life (QoL) as assessed with the SF-12 Health Survey, Kings’ Health Questionnaire, (KHQ), and EuroQol-5D (EQ-5D) was significantly improved in both arms, with no differences between arms. There were no significant differences in postoperative pain or complications.

Conclusions

Results of this trial demonstrate noninferiority between TVT and TVT-O with regard to postoperative continence and QoL and suggest little difference in perioperative problems (ClinicalTrials.gov NCT 00441454).     

Obturator nerve injury: a rare complication of retropubic tension-free vaginal sling

The tension-free vaginal tape (TVT) retropubic sling is a very effective treatment for stress urinary incontinence. High cure rates are typically achieved, and the reported complication rate is relatively low. Obturator neuralgia secondary to insertion of a midurethral sling is a rare and specific type of chronic pain that is more commonly associated with transobturator tape slings. The purpose of this video case report was to demonstrate that obturator nerve injury is a possible complication of TVT retropubic slings placement. A discussion of symptoms and signs of obturator nerve injury and how these should be managed is also presented.     

Prospective and randomized clinical trial comparing transobturator versus retropubic sling in terms of efficacy and safety

Introduction and hypothesis

The midurethral sling is the most commonly performed surgical procedure for stress urinary incontinence (SUI). We compared the efficacy of transobturator tape (TOT) and retropubic (RP) slings by evaluating objective and subjective cure rates at 12 months postsurgery and evaluate the impact on quality of life (QoL) and record intra- and postoperative complications.

Methods

This was a randomized, controlled, prospective, clinical trial with analysis of noninferiority. The hypothesis was that the TOT sling is not inferior to the RP sling. A total of 92 women with SUI were selected and randomized into two groups: TOT and RP slings.

Results

Eighty-one patients maintained follow-up 12 months postoperatively. In the per-protocol analysis, the objective cure rates were 100% for the RP sling and 93% for the TOT sling (p = 0.029). The subjective cure rates were 92% for the RP sling and 90% for the TOT sling (p = 0.02). Because none of the upper limits of the confidence interval (CI) were above the noninferiority margin, noninferiority of the TOT sling could be concluded. In contrast, the intention-to-treat analysis could not show that the TOT sling was not inferior to the RP sling, because the upper limit of the CI surpassed the noninferiority margin. Postoperative complications were similar for both groups, except for higher urinary retention rates in the RP group. Regarding QoL, there was a significant improvement.

Conclusions

The cure rates of the per-protocol analysis showed the noninferiority of the TOT relative to the RP sling. The RP sling group exhibited higher urinary retention. Quality of life improved significantly in both groups.

     

Retropubic tension-free vaginal tape and inside-out transobturator tape: a long-term randomized trial

Introduction and hypothesis

The tension-free vaginal tape (TVT) and inside-out transobturator tape (TVT-O) are first-line surgical treatments for stress urinary incontinence (SUI). However, there is a lack of information regarding the long-term comparative safety of these procedures.

Methods

A total of 140 SUI patients were randomized to the TVT or TVT-O procedure and were interviewed by an independent investigator at the follow-up. The primary outcomes were the proportions of patients with long-term postoperative complications. The secondary outcomes included the cure rates, quality of life (QOL) and sexual function based on validated questionnaires.

Results

One hundred and twenty (85.71 %) patients completed the long-term follow-up. More TVT patients experienced perioperative complications (P?<?0.05). However, in a mean follow-up of 95 months, no significant between-group difference was found in the proportions of patients with long-term complications or in the variety of reported complications. The long-term complication rates for TVT and TVT-O were 43.1 % and 27.4 % respectively (P?=?0.07). De novo voiding (15.8 %) and storage symptoms (10.8 %) were the primary long-term complications. Tape exposure was possible up to 7 years after TVT-O. The objective cure rates of TVT and TVT-O procedures were 79.30 and 69.35 % respectively, which were not significantly higher than the subjective rates. The Pelvic Floor Impact Questionnaire (PFIQ-7) scores remained improved (P?<?0.001) after both procedures, even at the 95-month follow-up. No difference was observed in the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire Short Form (PISQ-12) scores after either procedure.

Conclusions

In the long term, the proportion of patients with complications and the cure rates of the two procedures did not differ significantly. The long-term complication rates were high, but morbidity was low, and the QOL remained improved.

     

Predictors of vaginal mesh exposure after midurethral sling placement: a case–control study

Introduction and hypothesis

Female stress urinary incontinence is highly prevalent, and synthetic midurethral sling placement is the most common type of anti-incontinence surgery performed in the USA. We aimed to identify risk factors associated with surgery used to treated vaginal mesh exposure after midurethral sling placement for stress urinary incontinence.

Methods

We identified women who underwent anti-incontinence procedures from January 2002 through December 2012. Patients with vaginal mesh exposure undergoing surgical repair after midurethral sling placement were compared with a control group without mesh exposure in a 1:3 ratio. Patients with ObTape sling placement (Mentor Corporation) were excluded. Logistic regression models were used to evaluate associations between clinical risk factors and vaginal mesh exposure.

Results

Overall, 2,123 patients underwent primary sling placement, with 27 (1.3 %) having vaginal mesh exposure necessitating surgical repair. Patients with mesh exposure were more likely to have undergone previous bariatric surgery (P?=?0.008), hemoglobin <13 g/dL (P?=?0.006), premenopausal status (P?=?0.008), age <50 years (P?=?0.001), and the retropubic approach to sling placement (P?=?0.03). Multivariate analysis identified these risk factors: previous bariatric surgery (odds ratio [OR], 7.0; 95 % CI, 1.1–61.4), retropubic approach (OR, 5.7; 95 % CI, 1.1–107.0), preoperative hemoglobin <13 g/dL (OR, 2.8; 95 % CI, 1.1–7.5), and premenopausal status (OR, 2.6; 95 % CI, 1.0–7.3). Among postmenopausal patients, those with mesh exposure were significantly more likely to receive preoperative estrogen therapy (OR, 12.4; 95 % CI, 2.7–57.8).

Conclusions

Previous bariatric surgery, retropubic approach, premenopausal status, and lower preoperative hemoglobin were associated with a significantly increased risk of surgery for vaginal mesh exposure after midurethral sling placement. Recognizing these factors can improve preoperative patient counseling.

     

TVT and Sparc suburethral slings: a case–control series

Two midurethral slings, TVT and Sparc, are the subject of this case–control series aimed at assessing sling placement, voiding function, bladder symptoms and patient satisfaction. Thirty-seven Sparc and 69 TVT patients were matched for age, body weight, pre-existing urge incontinence, preoperative voiding, concomitant surgery and length of follow-up (mean 0.6, range 0.1–1.5 years). There were no significant differences for subjective cure/improvement, satisfaction or symptoms of incontinence. The clinical stress test was positive in 8/37 Sparc vs 4/69 TVT patients (p=0.019). The TVT had a more negative effect (p=0.001) on postoperative voiding. The Sparc was situated more cranially at rest and further from the symphysis pubis, and was more mobile (p<0.001) on Valsalva. There are significant differences in medium-term outcomes after TVT and Sparc, affecting tape placement, mobility, effect on voiding function and objective stress continence. Patient satisfaction and subjective cure rates seem similar.Abbreviations TVT Tension-free vaginal tapeEditorial Comment: The authors are to be commended for performing such timely research as clinicians struggle to understand the differences, if any, among the various minimally invasive midurethral slings that have been developed since the original tension-free tape (TVT) procedure. Despite the authors proposed explanation of a pretensioning effect, without intraoperative ultrasound measurements of tape displacement before and immediately after sheath removal, several other equally plausible explanations exist. It is also interesting to note the differences in postoperative voiding parameters and objective cure rates that once again remind us of the difficulty in surgically achieving high objective cure rates for stress incontinence without compromising normal outflow during micturition.