A randomized, nonblinded extension study of single-incision versus transobturator midurethral sling in women with stress urinary incontinence
| العنوان: | A randomized, nonblinded extension study of single-incision versus transobturator midurethral sling in women with stress urinary incontinence |
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| المؤلفون: | Jan-Paul W. R. Roovers, Dirk De Ridder, Sandra E. Zwolsman, Marcel G. W. Dijkgraaf, René P. Schellart, Jean-Philippe Lucot |
| المساهمون: | APH - Methodology, APH - Personalized Medicine, Obstetrics and Gynaecology, Clinical Research Unit, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, ARD - Amsterdam Reproduction and Development, APH - Digital Health, APH - Aging & Later Life |
| المصدر: | International urogynecology journal and pelvic floor dysfunction, 29(1), 37-44. Springer London |
| بيانات النشر: | Springer Science and Business Media LLC, 2017. |
| سنة النشر: | 2017 |
| مصطلحات موضوعية: | Adult, Reoperation, medicine.medical_specialty, Sling (implant), Urinary Incontinence, Stress, Urology, 030232 urology & nephrology, Urinary incontinence, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, medicine, Humans, Patient Reported Outcome Measures, Suburethral Slings, 030219 obstetrics & reproductive medicine, Intention-to-treat analysis, business.industry, Absolute risk reduction, Obstetrics and Gynecology, Middle Aged, Intention to Treat Analysis, Surgery, Treatment Outcome, Single incision, Quality of Life, Mann–Whitney U test, Female, medicine.symptom, business, Complication, Follow-Up Studies |
| الوصف: | Midurethral sling procedures are the first surgical option in women undergoing surgery for stress urinary incontinence (SUI). Single-incision midurethral-slings (SIMS) were designed to provide similar efficacy to traditional midurethral slings but with reduced morbidity. In this international trial we compared the efficacy of a SIMS (MiniArc) and a transobturator standard midurethral sling (SMUS; Monarc) in the treatment of SUI in terms of subjective and objective cure rates and morbidity over a long-term follow-up. This was a randomized controlled nonblinded extended trial with a follow-up period of 36 months. Women with symptomatic SUI were eligible. The primary outcome was subjective cure, defined as an improvement in the Patient Global Impression of Improvement (PGI-I) score. Secondary outcomes were objective cure (negative cough stress test), disease-specific quality of life, surgical parameters and morbidity. An intention to treat analysis was performed. Differences in dichotomous variables were tested using the chi-squared test. Differences in continuous variables were tested using Student’s t test or the Mann-Whitney U test. We hypothesized that MiniArc would be noninferior to Monarc concerning subjective cure. We randomized 97 women to the MiniArc group and 96 to the Monarc group. The attrition rate was 23% in the MiniArc group and 22% in the Monarc group after 3 years. At 36 months, the subjective cure rates were 86% in the MiniArc group and 87% in the Monarc group (risk difference −0.6%, 95% CI −12 to 11%). The objective cure rates were 89% and 88%, respectively (risk difference 1.3%, 95% CI −9 to 11%). Both procedures were associated with low complication rates. After a follow-up of 36 months, MiniArc (SIMS) is non-inferior to Monarc (SMUS) with respect to subjective and objective cure. |
| تدمد: | 1433-3023 0937-3462 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::dd4115ebd5d45186ead21f23c11656c8 https://doi.org/10.1007/s00192-017-3362-z |
| حقوق: | RESTRICTED |
| رقم الأكسشن: | edsair.doi.dedup.....dd4115ebd5d45186ead21f23c11656c8 |
| قاعدة البيانات: | OpenAIRE |
Find this article in full text from Springer Verlag. | تدمد: | 14333023 09373462 |
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