Multicenter Prospective Randomized Study of Single-incision Mini-sling Vs Tension-free Vaginal Tape-obturator in Management of Female Stress Urinary Incontinence: A Minimum of 1-Year Follow-up - 02/09/13
Abstract |
Objective |
To compare an adjustable anchored single incision mini-sling (SIMS-Ajust) vs tension-free vaginal tape-obturator (TVT-O) in the management of female stress urinary incontinence (SUI) with a minimum of 1-year follow-up.
Methods |
We conducted a multicenter prospective randomized control trial (RCT) performed in 6 United Kingdom centers in the period between October 2009 and October 2011. Women were randomized to either SIMS-Ajust (C. R. Bard) performed under local anesthesia or TVT-O (Ethicon Inc.) performed under general anesthesia. Women completed validated symptom-severity and quality of life (QOL) questionnaires preoperatively and at 1 year. In addition, women completed the Patient Global Impression of Improvement (PGI-I) and underwent the Cough Stress Test (CST) at 1 year. The primary outcome at 12 months was the patient-reported success rate. Secondary outcomes included objective cure, reoperation rate, impact on women's urinary symptoms, QOL, and sexual function. Data was analyzed using SPSS-19 with significance level set at 5%.
Results |
One hundred thirty-seven women were randomized into 2 groups: the SIMS-Ajust group (n = 69) and the TVT-O group (n = 68). At 1 year, there were no significant differences in the patient-reported success rate (odds ratio [OR] 0.895, 95% confidence interval [CI] 0.344-2.330, P = 1.000), objectives success rate (OR 0.929, 95% CI 0.382-2.258, P = 1.00), and reoperation rates (OR 0.591, 95% CI 0.136-2.576, P = .721) between the SIMS-Ajust and the TVT-O groups, respectively. A comparable number of women reported cure/improvement of urgency (P = .658), significant improvement in QOL (P = .190), and sexual function (P = .699) in both groups.
Conclusion |
Adjustable-anchored SIMS (Ajust) is associated with comparable patient-reported and objective success rates when compared to standard midurethral sling (SMUS, TVT-O) at a minimum of 1-year follow-up. The results should be interpreted with caution due to the relatively small cohort size. Long-term follow-up of this RCT is required to ascertain the durability of these results.
Le texte complet de cet article est disponible en PDF.Plan
| Financial Disclosure: Mohamed Abdel-Fattah, Wael Agur, and Karen Guerrero have received honorarium or paid consultancy from various pharmaceutical & devices companies including Bard, Astellas, Pfizer, AMS & Coloplast. Alyaa Mostafa, Wael Agur, Mohamed Abdel All, Karen Guerrero, Chu Lim, Mohamed Allam, Mohamed Yousef, and Mohamed Abdel-Fattah have received travel grants from different pharmaceutical companies to attend medical conferences. The remaining author declares that he has no relevant financial interests. |
|
| Funding Support: This study was funded by a Henry Smith Charity. |
|
| Declaration: All the authors, except James N'Dow, are members of the “Scottish Pelvic Floor Network.” |
Vol 82 - N° 3
P. 552-559 - septembre 2013 Retour au numéro
Article précédent
- Does Bariatric Surgery Affect Urinary Incontinence?
- Leise R. Knoepp, Michelle J. Semins, E. James Wright, Kimberly Steele, Andrew D. Shore, Jeanne M. Clark, Martin A. Makary, Brian R. Matlaga, Chi Chiung Grace Chen
- Editorial Comment
- Bertil F.M. Blok
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?