Obstetrics and gynecology · 2012
Three-year follow-up of tension-free vaginal tape compared with transobturator tape in women with stress urinary incontinence and intrinsic sphincter deficiency.
Сравнительное исследованиеСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Schierlitz Lore, Dwyer Peter L, Rosamilia Anna, Murray Christine, Thomas Elizabeth, De Souza Alison, Hiscock Richard
Аннотация
OBJECTIVE: To compare the efficacy of tension-free vaginal tape (TVT) to transobturator tape in the treatment of women with stress urinary incontinence (SUI) and intrinsic sphincter deficiency at 3-year follow-up.
METHODS: One hundred sixty-four women were randomized to either TVT or transobturator tape after diagnosis of urodynamic stress incontinence and intrinsic sphincter deficiency. Concomitant pelvic organ prolapse surgery was not an exclusion criterion. The primary outcome assessed at 3-year follow-up was symptomatic stress incontinence requiring repeat surgery. Secondary outcomes were quality-of-life parameters assessed by validated questionnaires and numerical success score.
RESULTS: One hundred sixty-four women were enrolled in the study. At 3 years, 15 of the 75 (20%) women in the transobturator tape group underwent repeat surgery to correct SUI compared with one of the 72 (1.4%) in the TVT group. In other words, if TVT had been used exclusively, repeat surgery would have been avoided in one in six patients. The risk ratio of repeat surgery was 15 (95% confidence interval 2-113; P<.001) times greater in the transobturator tape group. In the transobturator tape group, the median time to repeat surgery was 15.6 months compared with 43.7 months for TVT (P<.001). The quality-of-life outcomes did show an improvement in both groups before and after surgery but no difference between the two slings in the Urogenital Distress Inventory short form, the Incontinence Impact Questionnaire short form, and a patient-rated numerical success score.
CONCLUSION: The long-term cure rates for retropubic TVT are significantly greater than for transobturator tape in women with urodynamic stress incontinence and intrinsic sphincter deficiency. Urethral functions tests such as urethral closure pressure and Valsalva leak point pressures are of value in determining what surgery to perform.
CLINICAL TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, www.anzctr.org.au, ACTRN12608000093381.
LEVEL OF EVIDENCE: I.
METHODS: One hundred sixty-four women were randomized to either TVT or transobturator tape after diagnosis of urodynamic stress incontinence and intrinsic sphincter deficiency. Concomitant pelvic organ prolapse surgery was not an exclusion criterion. The primary outcome assessed at 3-year follow-up was symptomatic stress incontinence requiring repeat surgery. Secondary outcomes were quality-of-life parameters assessed by validated questionnaires and numerical success score.
RESULTS: One hundred sixty-four women were enrolled in the study. At 3 years, 15 of the 75 (20%) women in the transobturator tape group underwent repeat surgery to correct SUI compared with one of the 72 (1.4%) in the TVT group. In other words, if TVT had been used exclusively, repeat surgery would have been avoided in one in six patients. The risk ratio of repeat surgery was 15 (95% confidence interval 2-113; P<.001) times greater in the transobturator tape group. In the transobturator tape group, the median time to repeat surgery was 15.6 months compared with 43.7 months for TVT (P<.001). The quality-of-life outcomes did show an improvement in both groups before and after surgery but no difference between the two slings in the Urogenital Distress Inventory short form, the Incontinence Impact Questionnaire short form, and a patient-rated numerical success score.
CONCLUSION: The long-term cure rates for retropubic TVT are significantly greater than for transobturator tape in women with urodynamic stress incontinence and intrinsic sphincter deficiency. Urethral functions tests such as urethral closure pressure and Valsalva leak point pressures are of value in determining what surgery to perform.
CLINICAL TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, www.anzctr.org.au, ACTRN12608000093381.
LEVEL OF EVIDENCE: I.
Предметные рубрики MeSH
AgedConfidence IntervalsFemaleFollow-Up StudiesHumansIntention to Treat AnalysisKaplan-Meier EstimateMiddle AgedPressureProportional Hazards ModelsQuality of LifeReoperationRisk FactorsSuburethral SlingsSurveys and QuestionnairesTime FactorsUrethraUrinary BladderUrinary Bladder DiseasesUrinary Incontinence, StressUrodynamicsUrologic Surgical Procedures