A prospective randomized trial comparing tension-free vaginal tape and transobturator suburethral tape for surgical treatment of stress urinary incontinence

OBJECTIVE: The purpose of this study was to prospectively and randomly compare tension-free vaginal tape (TVT) with transobturator suburethral tape (T.O.T.) for the surgical treatment of stress urinary incontinence (SUI) in women. STUDY DESIGN: Sixty-one women with SUI were randomly assigned to either TVT (n=31) or T.O.T. (n=30). The preoperative evaluation included a quality-of-life questionnaire and a comprehensive urodynamic examination. The 1-year outcome included a detrusor pressure-uroflow study to compare bladder outlet obstruction. RESULTS: Patient characteristics, preoperative quality of life, and urodynamic evaluation were similar in the 2 groups. Mean operative time was significantly shorter in the T.O.T. group (15 min+/-4 vs 27 min+/-8, P<.001). No bladder injury occurred in the T.O.T. group versus 9.7% (n=3) in the TVT group (P>.05). The rate of postoperative urinary retention was 25.8% (n=8) in the TVT group versus 13.3% (n=4) in the T.O.T. group (P>.05). The rates of cure (83.9% vs 90%), improvement (9.7% vs 3.3%), and failure (6.5% vs 6.7%) were similar for the TVT and T.O.T. groups, respectively. The 1-year outcome data were collected in 29 women of the TVT group and 27 women of the T.O.T. group. No vaginal erosion occurred in either of the groups. In terms of bladder outlet obstruction, no differences were found after TVT and T.O.T. CONCLUSION: T.O.T. appears to be equally efficient as TVT for surgical treatment of stress urinary incontinence in women, with no reduction of bladder outlet obstruction at 1-year follow-up.     

Preliminary experience with transobturator tape for treatment of urinary incontinence in women

AIM: Aim of this study is to report our preliminary experience with a minimally invasive surgical procedure using transobturator approach. METHODS: We enrolled in our study 19 patients with stress urinary incontinence and urethral hypermobility without genital prolapse. All patients underwent suburethral transobturator tape (TOT) procedure. Four patients underwent previous surgical procedure for incontinence (3 Kelly and 1 Burch). No patients reported previous major gynaecological surgery. Mean age was 58.68 years (range 36-75). The sling was placed according to the technique described by Delorme. RESULTS: Mean operating time was 21 min (range 14-48). No bladder lesions or intraoperative complications occurred. Fifteen patients were dismissed the same day of surgery. Mean hospital staying was 1.4 days (range 1-5). No infections, erosions or sieromas have been observed. CONCLUSIONS: Our experience shows as TOT technique is extremely rapid, reproducible and with a very short learning curve. The transobturator approach avoids the risk of bladder, bowel or vascular injuries. Compliance and patient satisfaction have been very encouraging, restoring a real functional well-being. However, the small number of patients in our study and the short follow up do not actually allow us to draw definitive results and further studies are needed to confirm the technique success.     

Surgical treatment of stress urinary incontinence by suburethral transobturator tape

OBJECTIVE: Assessment of the suburethral transobturator tape in the treatment of female urinary stress incontinence. PATIENTS AND METHODS: Retrospective evaluation of 39 slings. Three patients (7%) were lost to follow-up. Analysis was carried on 19 out/in procedures (mainly ObTape and Uratape slings) and 17 in/out procedures (TVT-O slings). Nine patients (25%) had a history of previous stress incontinence surgery. In 21 cases (58%) there was a concomitant surgical procedure, including genital prolapse repair (12) and total hysterectomy (6). Phone interviews were conducted with the validated questionnaires MHU and Ditrovie short form. RESULTS: The mean operative time was 17 minutes (10-30). Three vaginal wounds (8%) were immediately repaired. Two urinary retentions (5%) were managed by suprapubic catheterization for more than 10 days. With a mean follow-up of 12 months (4-23) the subjective effectiveness on stress incontinence was 89% (cure: 58%; improvement: 31%). Urge incontinence symptoms were cured in 47% of mixed incontinences. Two patients reported an important dysuria. Two sling exposures occurred. Quality of life scores were significantly improved (mean 1,7 versus 3,2, p=0,002). The level of satisfaction reached 89% (very satisfied: 50%; satisfied: 39%). DISCUSSION AND CONCLUSION: This technique is safe and effective. Our results are nevertheless inferior to those previously reported. Prospective randomised studies comparing the two surgical routes are required.     

Tension-free transobturator tape procedure for stress urinary incontinence

PURPOSE OF REVIEW: Recent data on the tension-free transobturator tape procedure for the treatment of female stress urinary incontinence are reviewed. RECENT FINDINGS: Although long-term data are not available, the effectiveness and safety of the tension-free transobturator tape procedure as reported during the past 5 years are very promising and this procedure is becoming a popular surgical treatment for female stress urinary incontinence. The continence rates obtained have been similar to those obtained using the retropubic tension-free vaginal tape on short-term follow-up. Clinical data as well as studies on cadaveric dissections suggest that complication rates can be decreased significantly with the transobturator approach. In the original tension-free transobturator tape procedure, the tape is inserted through the obturator foramen from the outside-to-inside direction (skin incision to vaginal incision). The inside-to-outside approach with passage of the tape from the vaginal incision to the obturator foramen has also been described. SUMMARY: The tension-free transobturator tape procedure provides a useful alternative to the retropubic tension-free vaginal tape approach while maintaining the principles of tension-free midurethral support. By avoiding the intrapelvic and retropubic passage, complications can be decreased. The effectiveness of this approach is similar to that of tension-free vaginal tape on short-term follow-up.     

Effect of raloxifene on urinary incontinence: a randomized controlled trial

OBJECTIVE: To estimate the effect of 3 years of treatment with raloxifene on urinary incontinence in postmenopausal women. METHODS: We used measures of urinary incontinence severity, frequency, and type in the Multiple Outcomes of Raloxifene trial, a multicenter randomized, controlled trial of women who were at least 2 years postmenopausal with osteoporosis. At 10 U.S. sites of this trial, 963 women randomly assigned to raloxifene or placebo completed questionnaires about incontinence at baseline and 3 years later. We analyzed the odds of worsening severity and frequency of incontinence and type of incontinence after 3 years of treatment with raloxifene. RESULTS: The mean age of our subjects was 68.3 +/- 7 years. After 3 years of treatment, there was no significant difference between raloxifene and placebo groups in urinary incontinence severity (multivariable odds ratio [OR] 1.02; 95% [CI] 0.78, 1.34). The majority of the women (60%) had no change in urinary incontinence episodes from baseline to year 3. The odds of worsening urinary incontinence severity after 3 years of raloxifene treatment were 1.05 (95% CI 0.75, 1.48). Similarly, the odds of developing new onset incontinence were 0.95 (95% CI 0.59, 1.52). Finally, raloxifene did not effect the odds of having stress (OR 1.01; 95% CI 0.71, 1.43) or urge (OR 1.20; 95% CI 0.86, 1.68) incontinence after 3 years of use. CONCLUSION: In postmenopausal women with osteoporosis, 3 years of treatment with raloxifene had no effect on urinary incontinence. LEVEL OF EVIDENCE: I     

Residents performance in transobturator tape procedures for stress urinary incontinence

OBJECTIVES: The purpose of this study was to investigate the operative time, surgical complications and patient outcomes of the TOT surgery performed by an experienced surgeon compared to those performed by a senior resident under proper supervision by a senior surgeon. PATIENTS AND METHODS: A prospective, open label, randomized study was conducted at the department of urogynecology of the Ministry of Health Ankara Etlik Maternity and Women's Health Teaching Research Hospital between June 2003-June 2004. The study included 60 women who had stress urinary incontinence. Patients were randomly allocated to either the TOT surgery performed by an experienced surgeon group (Group 1, n=30) or the TOT surgery performed by a senior resident under proper supervision by a senior surgeon group (Group 2, n=30). The operative time, intraoperative and postoperative complications, intraoperative blood loss and the effectivity of the TOT procedure were recorded by a senior surgeon who did not participate to the operation. RESULTS: The study was completed by 55 women. Baseline characteristics were comparable between the two groups. The mean operative time was significantly long in Group 2 compared with Group 1 (27 min [15-48]; 13 min [7-22], respectively). There was no difference between the Groups 1 and 2 in terms of the intraoperative and postoperative complications. No bladder injury was noted in Group 1. One bladder injury was observed in Group 2 and the bladder was repaired in the usual form by the assisting senior surgeon. Urinary retention was observed in two patients in Group 2 and the tapes were cut 7 days after the operation. Both of the patients have been dry since the intervention. The mean follow up period was 30 months. After the follow up period, there were no statistically significant differences in terms of cure, partial recovery and failure between two groups. CONCLUSION: There is no difference in the outcome when TOT is performed by residents under proper supervision.     

Physiotherapy for persistent postnatal stress urinary incontinence: a randomized controlled trial

OBJECTIVE: The aim of this study was to compare the effectiveness of multimodal supervised physiotherapy programs with the absence of treatment among women with persistent postnatal stress urinary incontinence. METHODS: This was a single-blind randomized controlled trial. Sixty-four women with stress urinary incontinence were randomly assigned to 8 weeks of either multimodal pelvic floor rehabilitation (n = 21), multimodal pelvic floor rehabilitation with abdominal muscle training (n = 23), or control non-pelvic floor rehabilitation (n = 20). The primary outcome measure consisted of a modified 20-minute pad test. The secondary outcome measures included a Visual Analog Scale describing the perceived burden of incontinence, the Urogenital Distress Inventory, the Incontinence Impact Questionnaire, and pelvic floor muscle function measurements. RESULTS: Two patients dropped out, leaving 62 for analysis. At follow-up, more than 70% of the women in the treatment groups (14/20 in the pelvic floor and 17/23 in the pelvic floor plus abdominal group) were continent on pad testing compared with 0% of women in the control group. Scores on the pad test, Visual Analog Scale, Urogenital Distress Inventory, and Incontinence Impact Questionnaire improved significantly in both treatment groups (all P <.002), whereas no changes were observed in the control group. Pelvic floor muscle function, however, did not improve significantly in either active group. CONCLUSION: Multimodal supervised pelvic floor physiotherapy is an effective treatment for persistent postnatal stress urinary incontinence.     

Review of transobturator and retropubic tape procedures for stress urinary incontinence

PURPOSE OF REVIEW: Recently, various types of tension free vaginal tapes via retropubic and transobturator route (inside-out technique; outside-in technique) have been adopted for treatment of stress urinary incontinence. The aim of this review is to assess the recent evidence on effectiveness and complications of these tapes in stress urinary incontinence. RECENT FINDINGS: There was no significant difference found between tension free vaginal tapes and colposuspension for the cure of stress urinary incontinence at 5 years in a multicentre randomized controlled trial. Vault and posterior vaginal wall prolapse were commoner after colposuspension. A recent systematic review and meta-analysis reported that subjective cure for inside-out technique (five randomized controlled trials) and outside-in technique (six randomized controlled trials) at 2-12 months was no better when compared with tension free vaginal tapes (odds ratio: 0.85; 95% confidence interval: 0.60-1.21). Bladder injuries (odds ratio: 0.12; 95% confidence interval: 0.05-0.33) and voiding difficulties (odds ratio: 0.55; 95% confidence interval: 0.31-0.98) were less common, whereas groin/thigh pain (odds ratio: 8.28; 95% confidence interval: 2.7-25.4) and vaginal injuries or mesh erosion (odds ratio: 1.96; 95% confidence interval: 0.87-4.39) were more common in transobturator tapes. Sexual function was overall improved; the pain being more with outside-in technique than inside-out technique route. SUMMARY: The tension free tapes are effective in treating stress urinary incontinence; evidence for superiority of transobturator over retropubic tapes is currently limited.     

The effect of behavioral therapy on urinary incontinence: a randomized controlled trial

OBJECTIVE: To evaluate the effect of a low-intensity behavioral therapy program on urinary incontinence in older women. METHODS: A randomized clinical trial for community-dwelling women at least 55 years reporting at least one urinary incontinent episode per week was conducted. Women were randomly assigned to a behavioral therapy group (n = 77) or a control group (n = 75). The treatment group had six weekly instructional sessions on bladder training and followed individualized voiding schedules. The control group received no instruction but kept urinary diaries for 6 weeks. After this period, the control group underwent the behavioral therapy protocol. Using per-protocol analyses, t and chi(2) tests were used to compare the treatment and control groups, and paired t tests were used to evaluate the efficacy of behavioral therapy for all women (treatment and control groups before and after behavioral therapy). RESULTS: Women in the treatment group experienced a 50% reduction in mean number of incontinent episodes recorded on a 7-day urinary diary compared with a 15% reduction for controls (P =.001). After behavioral therapy, all women had a 40% decrease in mean weekly incontinent episodes (P =.001), which was maintained over 6 months (P <.004). Thirty (31%) women were 100% improved (dry), 40 (41%) were at least 75% improved, and 50 (52%) at least 50% improved. There were no differences in treatment efficacy by type of incontinence (stress, urge, mixed) or group assignment (treatment, control). CONCLUSION: A low-intensity behavioral therapy intervention for urinary incontinence was effective and should be considered as a first-line treatment for urinary incontinence in older women.     

Improvement of sexual function after transobturator tape procedure in women with stress urinary incontinence

Sling procedures are a widely proven treatment for stress urinary incontinence. The aim of this prospective study was to evaluate the effect of the transobturator tape on female sexual functioning. Fifty-four women treated for stress urinary incontinence with transobturator tape filled out self-administered questionnaires on quality of life, urinary incontinence, and sexual function prior to surgery and 6 weeks and 12 months postoperatively. Preoperatively, 40 women (78%) were sexually active. There were no significant postoperative changes regarding frequency of sexual activity, sexual desire, and problems with lubrication or orgasm. Preoperatively, 55% reported urinary leakage during sexual activity and after surgery 6.5%. Sexual satisfaction was significantly improved 6 weeks (p = 0.05) and 12 months (p = 0.03) postoperatively. Pain during or after sexual activity was declined, only one patient reported worsening of pain. The transobturator tape procedure has a positive effect on female sexual functioning by reducing urinary leakage and pain during or after sexual activity. It seems to improve the overall sexual satisfaction. Further research is warranted to support these preliminary findings.     

Clinical and ultrasonographic comparison of tension-free vaginal tape and transobturator tape procedure for the treatment of stress urinary incontinence

STUDY OBJECTIVE: The purpose of this study was to compare tension-free vaginal tape (TVT) and the TVT-obturator (TVTO) procedures. DESIGN: Multicenter retrospective cohort study (Canadian Task Force classification II-2). SETTING: Tertiary teaching hospitals. PATIENTS: We reviewed 82 women with urodynamically proven stress incontinence undergoing either TVT (n = 53) or TVTO (n = 29) without concomitant surgery. INTERVENTION: TVT and TVTO procedure. MEASUREMENTS AND MAIN RESULTS: All subjects underwent urinalyses, 1-hour pad testing, perineal ultrasonography, and urodynamic studies, as well as validated questionnaires before and 1 year after surgery. Mean operative time was significantly shorter in the TVTO group (16.8 +/- 10.7 minutes vs 28.6 +/- 6.9min, p <.01; unpaired t-test). The subjective and objective cure rates were comparable for the TVT and TVTO groups (p = .085 vs .19, respectively; Fisher's exact test). At rest or during Valsalva, the middle of the TVTO tape localized more distally than that of TVT on ultrasound scanning (p <.01; unpaired t-test). A higher rate of urethral kinking during straining was noted in the TVT group compared with the TVTO group after surgery (87% vs 25%, p <.01; chi2 test). After TVT, maximum urethral closure pressure increased significantly (83.6 +/- 24.6 cm H2O vs 69.2 +/- 25.9 cm H2O, p <.05), but this was not the case in the TVTO group (67.8 +/- 15.0 cm H2O vs 63.2 +/- 12.3 cm H2O, p >.05; paired t test). CONCLUSION: With comparable subjective and objective cure rates, TVTO has the advantages over TVT with shorter operative time. However, the TVTO tape is at a less acute angle and localizes to a more distal part of the urethra, resulting in a lower rate of urethral kinking and less urethral compression.     

Delayed positioning of multifilament tape (IVS transobturator tape) in treatment of stress urinary incontinence caused by the radiotherapy

Radiotherapy is used to treat advanced stages of cervical cancer. Despite optimization of the doses delivered during radiotherapy chronic urinary tract complications still occur in 1-5% of patients. We report a case of 60 years old woman, treated 10 years ago for stage III cervical carcinoma. She received both intracavitary brachytherapy and external teletherapy. Since irradiation patient suffered from the stress urinary incontinence (SUI). She was diagnosed in our department and underwent successful anti-incontinence surgery. Because of oncological history and urodynamic parameters (markedly lowered closing urethral pressure) she was assigned to intravaginal slingplasty transobturator (IVS-OT) procedure with delayed positioning of the tape. There were no intra- or postoperative complication. The check-up done four months following surgery revealed that patient have full control of micturition and markedly improved quality of life.     

Vaginal tape erosion following transobturator tape (TOT) operation for stress urinary incontinence.

Inorganic sling materials when used for treatment of urinary stress incontinence have a high success rate of achieving continence. They unfortunately attract the complication of vaginal tape erosion. When used for Transobturator tape procedure (TOT) we found the Obtape sling (Mentor-Porges, Le Plessis-Robinson, France) attracted a high rate of erosion, likely due to the tape properties. We describe a series of tape erosions with the Obtape sling, the presentation, conservative and surgical management with favourable rates of maintenance of continence. We suggest the use of larger pore sized tapes to decrease the occurrence of vaginal tape erosion.     

De novo urgency after tension-free vaginal tape versus transobturator tape procedure for stress urinary incontinence

Objective

To determine the frequency of de novo urgency after tension-free vaginal tape (TVT) compared with the transobturator tape (TOT) procedure in women with stress urinary incontinence (SUI).

Study design

Prospective study of all consecutive women with urodynamically confirmed SUI undergoing anti-incontinence surgery between January 2000 and January 2008. All procedures were performed by experienced urogynaecologists well trained in TVT and TOT surgery. Assessments were carried out at 1, 6, 12 and, 36 months after surgery.

Results

The study population included 366 women (mean age 59.5 years), 243 in the TVT group and 123 in the TOT group. The groups were similar in terms of demographics, preoperative data, and cure rates. De novo urgency occurred in 13.4% of patients at 6 months after surgery, in 19.3% at 12 months, and in 22.1% at 36 months. De novo urgency was significantly more frequent in the TVT group than in the TOT group at 12 (22.2% vs 11.2%, P = 0.025), 24 (24.8% vs 12.3%, P = 0.033), and 36 (0% vs 24.7%, P = 0.034) months. Cure rates were similar in both groups. The final adjusted cure rate was 87.3% (319/366).

Conclusion

Treatment of SUI using the TOT procedure was associated with a lower rate of de novo urgency.