Laparoscopic Burch Colposuspension Versus Transobturatory Tape for the Treatment of Female Urinary Stress Incontinence
|Stress Urinary Incontinence||Procedure: Laparoscopic Burch colposuspension Procedure: Transobturator tape procedure||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Comparison Between Laparoscopic Burch Colposuspension and Transobturatory Tape (TOT) for the Treatment of Female Urinary Stress Incontinence|
- Objective/subjective symptoms improvements [ Time Frame: 12 months ]
- Intra-operative complication rate [ Time Frame: one day ]
- Postoperative complications rate [ Time Frame: 12 months ]
- Failure rate [ Time Frame: 12 months ]
- Recurrence rate [ Time Frame: 12 months ]
- Quality of life [ Time Frame: 12 months ]
- Sexual function [ Time Frame: 12 months ]
|Study Start Date:||September 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
|Active Comparator: Group A||
Procedure: Laparoscopic Burch colposuspension
Lapaparoscopic approach. One or two nonadsorbable sutures are placed at the level of the midurethra without penetrating the vaginal mucosa and fixed to Cooper's ligament with a tension free knotting technique.
|Experimental: Group B||
Procedure: Transobturator tape procedure
Small incision sites in the vagina and in the femoral/pelvic fold. Bilateral transobturator insertion of mesh by means of needle. Application of resorbable tensioning suture that maintains the mesh and enables fine adjustments in mesh tension during the procedure and in the immediate postoperative period.
Women with predominant and genuine stress urinary incontinence will be enrolled and randomized in two groups (groups A and B). Patients of group A will be treated with laparoscopic Burch colposuspension, whereas patients of group B will be treated with TOT procedure.
All patients eligible will undergo baseline assessment consisting of anthropometric, clinical, hormonal, urodynamic, and ultrasonographic evaluations. During the study, the surgical outcomes, the clinical subjective and objective efficacy data, and the adverse experiences will be evaluated in each patient.
Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00573703
|Catanzaro, Italy, 88100|
|Principal Investigator:||Stefano Palomba, MD||Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro|
|Study Chair:||Fulvio Zullo, MD||Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro|