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.     

Surgery for stress urinary incontinence in Finland 1987–2009

Introduction and hypothesis

To estimate the incidence rates of stress urinary incontinence (SUI) surgery among Finnish women from 1987 to 2009 by age, and to evaluate the trends in SUI surgery.

Methods

We conducted a retrospective register-based study. All SUI procedures on adult women over age 18 years in Finland were identified from the nationwide Care Register for Health Care. Age-specific incidence rates per 1,000 women were calculated for each year. The cumulative incidence of SUI surgery was calculated.

Results

There were 38,340 procedures for SUI in 1987–2009. The overall age-adjusted incidence rate increased 2.6-fold from 0.5/1,000 women in 1987 to 1.3/1,000 in 2002, but declined thereafter by 2009 to 0.8/1,000. There was a six-fold increase in the incidence rate in the age group 60–69 years and a ten-fold increase in the age group 70–79 years from 1987 to 2002. These marked increases in operation rates coincided with the increased use of tension-free vaginal tape (TVT). In 2002, TVT accounted for 96 % of all SUI procedures. Mid-urethral slings with transobturator techniques surpassed TVT in popularity in 2007. The life-long cumulative incidence of SUI surgery was 9.9 % in 2002 and 6.3 % in 2009.

Conclusions

The incidence rates of SUI surgery increased significantly in Finland, especially among women aged 60 to 79 years. Mid-urethral slings have become the dominant procedure.

     

Transobturator tape versus retropubic tension-free vaginal tape for stress urinary incontinence: 5-year safety and effectiveness outcomes following a randomised trial

Introduction and hypothesis

In a randomised trial comparing transobturator tape (TOT) to retropubic tension-free vaginal tape (TVT) for women with stress urinary incontinence (SUI), vaginal examination at 12 months showed that tapes were palpable for 80.0 % of the TOT group versus 26.7 % of the TVT group. We hypothesized that this difference would lead to more women in the TOT group experiencing vaginal mesh erosion or other serious adverse events compared to women in the TVT group 5 years after surgery.

Methods

All participants were invited to join the follow-up study after being randomised to receive TOT or TVT for SUI. Consenting women had a vaginal examination, a pad test for urinary incontinence (UI) and completed Health-related Quality of Life Questionnaires (HRQOL). Women unable to attend the clinic completed questionnaires only. The primary composite outcome incorporated mesh exposure, urinary retention, repeat incontinence surgery and moderate to severe pelvic pain. Assuming 80 % follow-up, our study would have 67 % power to detect a difference in primary outcome (two-sided 5 % level of significance). Comparisons between groups used chi-square tests and t tests.

Results

One hundred and seventy-six (88.4 %) women participated in the 5-year follow-up (83 TOT, 93 TVT). The primary composite outcome occurred in 21.8 % of the TOT and 27.6 % of the TVT groups [difference?=?5.8 %, 95 % confidence interval (CI) ?18.9 % to 7.3 %, p value 0.39)] Vaginal examination found more women with palpable tapes in the TOT versus the TVT group (48.5 % versus 22.4 %, p value 0.001). There were no other significant differences between groups.

Conclusions

Serious adverse events and tape effectiveness did not differ between groups at 5 years. Palpable tape remains a concern for women who receive TOT for treating SUI.

     

Population-based trends in ambulatory surgery for urinary incontinence

Introduction and hypothesis

Surgical procedures for stress urinary incontinence (SUI) have become progressively less invasive and easier to perform with the development of new technologies such as the midurethral sling. For these reasons, it seems logical to conclude that midurethral slings would supplant other surgical treatments for incontinence. The purpose of this study was to assess the impact of this technology on trends in ambulatory surgery for incontinence over the past decade.

Methods

We searched Current Procedure Terminology codes and the State Ambulatory Surgery Database from 2001 through 2009 to identify all ambulatory procedures for incontinence. Next, we calculated age-adjusted rates separately for each procedure. We then fit a multilevel model to characterize patient and regional factors associated with the preferential use of midurethral slings over alternative treatments.

Results

Midurethral slings and submucosal injections comprised >90 % of all ambulatory procedures for SUI during the time period examined. Age-adjusted rates of midurethral slings increased dramatically, from 2.36 to 9.45/10,000 population (p?<?0.001), whereas rates of submucosal injections remained relatively stable, from 1.75 to 1.41/10,000 population (p?=?0.226). Not surprisingly, older ([odds ratio (OR) 0.61; 95 % confidence interval (CI) 0.56–0.66] and more infirm patients (OR 0.60; CI 0.44–0.83) were more likely to receive submucosal injection therapy than to receive midurethral slings.

Conclusions

Rates of midurethral slings have increased significantly by fourfold. Rates of submucosal injections, however, have remained fairly stable during this time period, suggesting that sling dissemination has led to an increase in rates of incontinence procedures as opposed to replacing old technologies in the ambulatory setting.     

Usefulness of retropubic tape for recurrent stress incontinence after transobturator tape failure

Introduction and hypothesis  

This study was conducted to evaluate the effectiveness and safety of retropubic suburethral slings (TVT) to treat recurrent stress urinary incontinence (SUI) after transobturator tape (TOT) failure.     

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.     

Tension-free vaginal tape versus transobturator tape for treatment of female stress urinary incontinence

Objectives  

The transobturator tape (TOT) is based on a similar principle as the tension-free vaginal tape (TVT), but introduced through the obturator foramen. The aim of this study was to compare these slings as surgical procedures for the treatment of stress urinary incontinence (SUI) in women.     

Incidence and risk factors for reoperation of surgically treated urinary incontinence

Introduction and hypothesis

The objective of our study was to estimate the incidence and to identify the risk factors for reoperation of surgically treated stress urinary incontinence (SUI).

Methods

We conducted a nested case-control study among 1,132 women who underwent SUI surgery from January 1988 to June 2007. Cases (n?=?35) were women who required reoperation for SUI following the first intervention up to December 2008. Controls (n?=?89) were women randomly selected from the same cohort who did not require reoperation.

Results

The cumulative incidence of SUI reoperation was 3.1 % with a mean follow-up of 10.9 years (range 1.7–21.0). The main risk factor was the history of more than one vaginal delivery [adjusted odds ratio (OR) 3.5; 95 % confidence interval (CI) 1.0–12.6]. The use of synthetic midurethral slings was a protective factor compared to other surgical procedures for urinary incontinence (adjusted OR 0.1; 95 % CI 0.0–0.6).

Conclusions

The risk of reoperation after SUI surgery appears to be low and associated with multiple vaginal deliveries. Synthetic slings at index surgery are associated with a lower risk of reoperation.     

A randomized comparison between monofilament and multifilament tapes for stress incontinence surgery

Our objective was to compare monofilament and multifilament tapes positioned without tension at the midurethra for postoperative complications and cure rate. One hundred patients with stress urinary incontinence were randomly allocated into two study groups. Using identical surgical methodology, 50 patients had a monofilament tape inserted at the midurethra using the TVT delivery instrument, and another 50 a multifilament tape using the IVS delivery instrument. The only significant difference between the groups was in the incidence of postoperative urinary retention (p=0.023). Ten patients from the monofilament group required longer than normal (normal means to the morning of the next day) catheterization, in contrast to only two from the multifilament group. The clinical efficacy of both procedures was equally high. Conclusions were that both tapes appear to be equally effective in the surgical treatment of SUI. The higher incidence of postoperative urinary retention in the monofilament group was most likely caused by the elastic feature of this tape.Abbreviations ISD Intrinsic sphincter deficiency - PVR Postvoid residual volume - SUI Stress urinary incontinence - TVT Tension-free vaginal tape - UPP Urethral pressure profile Editorial Comment: For many surgeons, the TVT sling has become the standard of care for the treatment of stress urinary incontinence. Since its introduction less than 10 years ago, TVT has become one of the best-studied procedures in gynecology, with many papers demonstrating its consistent efficacy and safety. This paper demonstrates the efficacy and safety of two minimally invasive slings: the original TVT sling, and the IVS procedure. The basic procedure is nearly identical for these two operations, including minimal paraurethral dissection and midurethral placement of a synthetic sling. The main difference is the physical properties of the polypropylene mesh. TVT is a monofilament mesh that has elastic properties. This accounts for its Velcro-like ability to bind to surrounding tissues, which obviates the need to suture the mesh to the rectus fascia. The IVS device utilizes a multifilament weave, which has minimal elasticity and does not bind firmly to the surrounding tissues. The authors demonstrate comparable efficacy and safety, with a significantly higher rate of urinary retention in the TVT group. Larger studies are needed to determine whether this finding is consistent and of clinical significance.     

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.     

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.     

Tension-free midurethral slings in the treatment of female stress urinary incontinence: a systematic review and meta-analysis of randomized controlled trials of effectiveness

OBJECTIVES: To evaluate the efficacy of tension-free vaginal tape (TVT) compared with other surgical treatments for stress urinary incontinence (SUI) and with other tension-free midurethral slings. METHODS: A systematic review of the literature was performed in January 2007 using MEDLINE, Embase, and Web of Science. The searches used both "MeSH" and "free text" protocols. Meta-analysis was conducted using the Review Manager software 4.2 (Cochrane Collaboration). RESULTS: Our search identified 37 randomized controlled trials. According to the Jadad score, the quality of the evaluated studies was limited in most papers. TVT outperformed Burch colposuspension in terms of postoperative continence rates (odds ratio [OR] from 0.38 to 0.59, according to the different end points), whereas success rates were similar after TVT and pubovaginal slings. Comparing TVT to the other retropubic tension-free midurethral vaginal slings, TVT was more efficacious than both intravaginal slingplasty (IVS; OR = 0.47; p = 0.007) and suprapubic arc (SPARC; OR from 0.53 to 0.56 according to the different evaluated end points). Indeed, the available data suggest similar efficacy for retropubic and trans-obturator tapes both in terms of subjective (OR = 0.98; p = 0.92) and objective (OR = 0.81; p = 0.34) cure rates. CONCLUSIONS: Our meta-analysis showed that TVT outperformed Burch colposuspension; efficacies of TVT and pubovaginal sling were similar. TVT was more efficacious than IVS and SPARC, whereas retropubic and trans-obturator tapes showed overlapping cure rates. The poor quality of most of the studies, both in terms of methodologic and clinical parameters, limits the strengths of the recommendations derived by the meta-analysis.     

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.     

Indications and risk factors for midurethral sling revision

Introduction and hypothesis

To determine the indications and risk factors for needing midurethral sling revision in a cohort of women undergoing midurethral sling placement.

Methods

This was a case–control study of all women undergoing midurethral sling placement for stress urinary incontinence (SUI) between January 2003 and December 2013. Cases were patients who underwent midurethral sling placement followed by sling revision (incision, partial or complete excision). Controls were patients who underwent sling placement only. Once all subjects had been identified, the electronic medical record was queried for demographic and perioperative and postoperative data.

Results

Of 3,307 women who underwent sling placement, 89 (2.7 %, 95 % CI 1.9 – 3.4) underwent sling revision for one or more of the following indications: urinary retention (43.8 %), voiding dysfunction (42.7 %), recurrent urinary tract infection (20.2 %), mesh erosion (21.3 %), vaginal pain/dyspareunia (7.9 %), and groin pain (3.4 %). The median time from the index to the revision surgery was 7.8 months (2.3 – 17.9 months), but was significantly shorter in patients with urinary retention. The type of sling placed (retropubic or transobturator) was not associated with indication for revision. Patients who underwent revision surgery were more likely to have had previous SUI surgery (adjusted odds ratio 4.4, 95 % CI 1.7 – 6.5) and to have undergone concomitant vaginal apical suspension (adjusted odds ratio 2.4, 95 % CI 1.4 – 4.5).

Conclusions

The rate of sling revision after midurethral sling placement was 2.7 %. Urinary retention and voiding dysfunction were the most common indications. Patients with a history of previous SUI surgery and concomitant apical suspension at the time of sling placement may be at higher risk of requiring revision surgery.

     

Short‐term assessment of a tension‐free vaginal tape for treating female stress urinary incontinence

OBJECTIVE

To evaluate the short‐term surgical complications and results of a tension‐free vaginal tape (TVT) system (TVT‐Secur^TM, Gynecare, Ethicon, Somerville, NJ, USA) in the treatment of female stress urinary incontinence (SUI).

PATIENTS AND METHODS

TVT‐Secur was applied to 107 women with SUI through a vaginal incision and left abutting the urethra. Postoperative pain, complications, de novo lower urinary tract symptoms, incontinence cure rate and the King’s Health Questionnaire (KHQ) score were evaluated.

RESULTS

The operative duration was 12 min; the mean pain score was 2.3 and only one patient had transient voiding difficulties. After a mean follow‐up of 15 months, 71% of the patients were dry and 14% improved. The KHQ scores decreased significantly for most subscores. Urgency appeared de novo in six patients (5.6%), and vaginal erosion required one TVT‐Secur explantation.

CONCLUSION

This study shows that TVT‐Secur is a simple and safe treatment for female SUI, but before recommending this sling as a first choice for treating SUI, TVT‐Secur must pass the test of time and comparative studies with conventional slings.     

经耻骨后和经闭孔尿道中段无张力悬吊术治疗女性压力性尿失禁的疗效观察

目的:观察经耻骨后和经闭孔尿道无张力悬吊术治疗女性压力性尿失禁(Stress urinary incontinence,SUI)的疗效。方法:选择女性SUI患者198例,病程2~25年,平均7.3年;年龄41~78岁,平均58.3岁。采用经耻骨后无张力阴道吊带术(tension-free vaginal tape,TVT,57例为TVT组)或经闭孔尿道下无张力吊带术(transobturator vaginal tape inside-out,TVT-O,141例为TVT-O组)进行治疗。结果:本文患者随访6~120个月,179例(90.4%)治愈,其中TVT组平均随访86个月,治愈51例(89.5%),改善4例(7%);TVT-O组平均随访38个月,治愈128例(90.7%),改善6例(4.3%);疗效不佳9例(3.5%)。TVT组2例发生膀胱穿孔(3.5%),TVT-O组3例出现腹股沟血肿伴下肢大腿根部疼痛,2例出现短期单下肢活动障碍,但经保守治疗均好转;术后拔除尿管后排尿困难5例,其中TVT组2例,TVT-O组3例,经多次下压式尿道扩张及延长保留尿管后解除梗阻、恢复正常排尿4例;TVT组中1例采用尿道扩张无效而剪断悬吊带。结论:经阴道中段无张力悬吊术(尤其是TVT-O)操作简便,疗效佳,并发症少,是治疗女性SUI的有效方法。     

Effectiveness of midurethral slings in recurrent stress urinary incontinence: a systematic review and meta-analysis

Introduction and hypothesis

Midurethral slings (MUS) are the gold standard primary procedure for the surgical treatment of stress urinary incontinence (SUI). There is no robust evidence on the success with MUS in the treatment of recurrent SUI. Our objective was to evaluate the effectiveness and complications of MUS in women with recurrent SUI by systematic review and meta-analysis of the literature.

Methods

A systematic literature search was carried out (up to August 2011) using relevant search terms in MEDLINE, EMBASE, CENTRAL and Google Scholar. Relevant randomised controlled trials (RCT) and prospective studies were selected and then analysed by two independent reviewers. Meta-analysis of cure stated in prospective cohort studies was performed with a random effects model using Stata 8.

Results

There was 1 randomised trial and 11 good quality prospective studies included in this systematic review. The overall subjective cure rate per meta-analysis of prospective cohort studies following MUS for recurrent SUI after any previous surgery was found to be 78.5?% [95?% confidence interval (CI) 69–88] at the follow-up of 29.72?±?29.49?months. The subjective cure rate following MUS after previous failed MUS was 73.3?% (95?% CI 55–97) at the follow-up of 15.7?±?7.7?months.

Conclusions

The studies report good cure rates of SUI after MUS surgery following previous incontinence surgery (62–100?%). There seems to be a lower cure rate with transobturator compared to the retropubic tape for recurrent SUI after previous surgery.     

Informed consent checklists for midurethral slings: a common-sense approach

Introduction and Hypothesis

Following the US Food and Drug Administration’s (FDA’s) warning about the use of transvaginal mesh to treat pelvic organ prolapse (POP) and the use of single-incision slings to treat incontinence, the number of lawsuits for medical negligence regarding the use of any polypropylene mesh in the vagina has increased tremendously.

Methods

This same FDA document did not question the use of polypropylene midurethral slings and polypropylene for sacrocolpopexies. Surprisingly, despite all the evidence and recommendations from respected international scientific societies, we are constantly being called upon by our patients to defend the use of midurethral slings. The most common reasons for the new rash of medicolegal proceedings involving midurethral slings has to do with “breach of duties” resulting from undisclosed postoperative complications on the consent form and/or the lack of information in the medical records confirming that all possible alternative treatment options were presented to and discussed with the patient.

Results

One response to these lawsuits involves the addition of preoperative checklists when performing informed consent with patients electing surgical correction of stress urinary incontinence (SUI).

Conclusions

This clinical opinion provides an expert clinician’s perspectives and legal point of view on this controversial topic and discusses the role of a preoperative checklist supplementary to the standard informed consent form.

     

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.

     

Long-term efficacy of the trans-obturator and retropubic mid-urethral slings for stress urinary incontinence: update from a randomized clinical trial

Purpose

To report the extended long-term results of the use of tension-free vaginal tape(TVT) and trans-obturator tape (TOT) for the treatment of female stress urinary incontinence (SUI).

Methods

A prospective, multicentre randomized clinical trial comparing the use of TVT and TOT was used to evaluate 87 patients. The inclusion criteria were stress or mixed UI associated with urethral hyper mobility (the stress component was clinically predominant), while the exclusion criteria were previous anti-incontinence surgery and/or pelvic organ prolapse. The objective cure criteria were a negative provocative stress test and a negative 1-h pad test, with no further treatment for SUI. The subjective cure criteria were a 3-day voiding diary, quality-of-life questionnaires (UDI6–IIQ7), and patient satisfaction on a scale from 0 to 10.

Results

Eighty-seven patients were evaluated (47 TOT and 40 TVT) at a median follow-up of 100 months. Subjective and objective cure rates were 59.6 and 70.2 % in the TOT group and 75 and 87.5 % in the TVT group. The mid-to-long-term trend was a decreasing continence rate in patients who underwent TOT, compared with a stable rate for TVT. The Kaplan–Meier survival curve showed that continence rate decreased for up to 25 months after surgery, with stabilization thereafter for the TVT group while continuing to drop in the TOT group, with no inter-group difference.

Conclusion

The patients in both groups were highly satisfied at long-term follow-up. The overall continence rate worsened for both groups within 25 months. While the results tend to stabilize in the TVT group, a further decline in the TOT was observed.