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.     

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

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 Meta-analyses of TVT-Secur versus SMUS are presented separately as the former was recently withdrawn from clinical practice.Evidence synthesisA total of 26 RCTs (n = 3308 women) were included.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

四种中段尿道吊带术治疗女性压力性尿失禁的比较

目的比较4种中段尿道吊带术治疗女性压力性尿失禁（stress urinary incontinence,SUI）的疗效。方法回顾分析80例行中段尿道吊带术的女性SUI患者的临床资料,其中改良Stamey法14例、In-fast法12例、TVT法42例及TVT-O法12例。结果组间比较,手术时间有显著性差异（P〈0.05）,其中TVT-O组时间最短,为（18.8±4.3）min,改良Stamey组时间最长,达（52.1±5.4）min。80例患者随访3~100个月,70例（87.5%）治愈,尿失禁症状完全消失;7例（8.75%）改善;3例（3.75%）失败。改良Stamey组、In-fast组、TVT组及TVT-O组治愈率分别为78.6%、75.0%、92.9%及91.7%,无统计学差异（P〉0.05）。改良Stamey组2例患者术后出现排尿困难,经多次下压式尿道扩张无效而剪断悬吊线;In-fast吊带组1例患者因阴道吊带外露而拆除,TVT组及TVT-O组术后各有1例患者出现排尿困难,经下压式尿道扩张后解除梗阻。结论4种尿道吊带术疗效相似,均为治疗女性压力性尿失禁安全、有效的方法;其中TVT-O因操作简单手术时间最短。     

自体筋膜尿道悬吊治疗女性压力性尿失禁的探讨

目的：探讨自体筋膜尿道悬吊术在女性压力性尿失禁治疗中的效果。方法：采用经耻骨上人路自体筋膜尿道中段悬吊术治疗女性压力性尿失禁,回顾性分析2000年2月～2007年12月采用该手术方式治疗28例女性压力性尿失禁患者的临床资料和治疗效果。结果：所有患者无耻骨后血肿形成,无尿道损伤;膀胱损伤1例,延长导尿管留置时间后治愈;28例患者术后拔除尿管均能自行排尿并满意控尿,6例患者出现不同程度不稳定膀胱症状,经对症处理缓解。随访9～21个月,平均15个月,无压力性尿失禁症状复发及排尿困难。结论：自体筋膜尿道悬吊术治疗女性压力性尿失禁简单易行,操作安全,损伤性较小,费用低廉。     

Voiding after gynecologic surgery: Experience with 24-hour Foley catheterization

Postoperative voiding was studied in 227 gynecologic patients after the introduction of a new routine of 24-hour Foley catheterization in all patients. After catheter removal 85% of patients (laparotomy 88.2%, colposuspension 85.2% and vaginal plastic surgery 80.3%) were able to void spontaneously, with residual urine <100 ml. 13.7% of patients had intermittent catheterization 1–3 times (mean 1.6) but established satisfactory voiding before evening. Altogether 98.7% of patients (laparotomy 99%, colposuspension 98.1%, vaginal surgery 98.6%) voided adequately before the end of the first postoperative day. One patient in each group had prolonged retention and required 3–63 days before voiding normally. The differences in retention rates between the three surgical groups were not statistically significant. The regimen of 24-hour postoperative Foley catheterization followed by intermittent catheterization if required is convenient and may be recommended after all common gynecologic operations.     

Complications of tension-free vaginal tape surgery: a multi-institutional review

OBJECTIVE: To analyse the complications of tension-free vaginal tape (TVT) surgery, a minimally invasive alternative for treating patients with stress urinary incontinence (SUI), at six institutions, and to review the management of these complications and their effect on patient outcome. PATIENTS AND METHODS: In all, 241 patients who had a TVT procedure by six urologists at six hospitals (two university and four community) were reviewed retrospectively by the same urologist. Complications during and after surgery, and their management, were analysed. RESULTS: Complications during surgery included bladder perforation in 48 patients (5.8%) and blood loss > 500 mL in 16 (2.5%). Immediate complications after surgery were urinary retention (>24 h after) in 47 patients (19.7%), pelvic haematoma in four (1.9%) and suprapubic wound infection in one (0.4%). Of the 47 patients in retention, 32 were in retention for <48 h and treated with an indwelling catheter. The 15 remaining patients were treated with an indwelling catheter (one) or clean intermittent catheterization for a mean of 22 days. To correct the retention the TVT was released in seven patients and the tape sectioned in three. Late complications were de novo urgency, persistent suprapubic discomfort and intravaginal tape erosion in 36 (15%), 18 (7.5%) and one (0.4%) patient, respectively. Most of these complications resolved with observation and medical management, but intravaginal tape erosion required partial resection of the tape with closure and repair of the vaginal mucosa. CONCLUSIONS: The present TVT complication rates were slightly higher than reported previously. This multi-institutional review in both academic and community hospitals may better reflect the morbidity of TVT insertion in clinical practice. TVT is a highly effective, minimally invasive method for treating SUI. A stricter definition of each complication and a better understanding of the mechanism of these complications may further improve the surgical outcome and decrease patient morbidity.     

Comparison of outcomes of three different surgical techniques performed for stress urinary incontinence

BACKGROUND: The aim was to compare the efficacy of Burch colposuspension, transvaginal four-corner bladder neck suspension (FCBNS) and the vaginal wall sling (VWS) procedures in patients with stress urinary incontinence. METHODS: A retrospective analysis was performed on 88 patients who underwent Burch colposuspension (n = 20), FCBNS (n = 29) and VWS (n = 39) for stress urinary incontinence. Objective and subjective cure rates at 3 months and annually after the operation were the primary outcome measures. RESULTS: The patients were similar in age, parity, menopausal status, grade of cystocel and preoperative residual urine volumes. Fourteen out of 20 (70%) patients showed improvement in the group undergoing Burch colposuspension, 29 out of 39 (74.4%) patients showed improvement in the FCBNS group, and 28 out of 29 (96.6%) patients showed improvement in the VWS group. The mean length of follow up was 3.8 years (range 3-5). CONCLUSION: In this study, the VWS procedure had a higher long-term cure rate of stress urinary incontinence when compared with the Burch colposuspension and the FCBNS 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.     

Urethral sphincter needle electromyography in women: Comparison of periurethral and transvaginal approaches

Needle electromyography (EMG) of the striated urethral sphincter is the only technique that permits detection of individual motor unit action potentials (MUAPs) and is a valuable diagnostic tool in the evaluation of women with urinary incontinence and voiding disorders. The purpose of this study was to compare two methods of urethral needle EMG with respect to the number of MUAPs identified, the amount of patient discomfort, and the duration of the examination. Twenty consecutive women referred for electrodiagnostic testing to evaluate symptoms of urinary incontinence and/or voiding dysfunction underwent both methods of the needle examination in a prospective randomized cross-over study design with each patient acting as her own control. A full cross-over analysis was conducted to detect period and sequence effects using analysis of variance with a power of 0.85 and a significance level of P < 0.05. Twice as many MUAPs were identified using the periurethral approach (8.8 versus 3.9) with a mean difference of 5.0 (P = 0.0008). There was a non-significant trend to greater patient discomfort with the periurethral approach; however, the discomfort was generally rated as mild to moderate. The length of time required to count all identifiable MUAPs did not vary significantly between the two methods. We conclude that the periurethral approach is superior to the transvaginal approach with respect to the quantity of electrodiagnostic information obtained and propose that this method be standardized to characterize more accurately the neurogenic component of urinary incontinence and voiding dysfunction for future electrodiagnostic studies. Neurourol. Urodynam. 17:531–535, 1998. © 1998 Wiley-Liss, Inc.