Autologous Versus Synthetic Versus Biological Sling for Trans-obturator Correction of Urinary Stress Incontinence
Recruitment status was: Recruiting
The treatment of urinary stress incontinence with trans-obturator approach, know as transobturatory tape (TOT), is a largely used sling-adopting procedures. The efficacy and safety of this minimally invasive surgery have been demonstrated, also in comparison with similar procedures, i.e transvaginal tape (TVT).
To date the results of TOT in terms of efficacy and safety described in literature mainly refer to procedure in which synthetic materials are used, whereas few data regarding the use of biological materials are available. Moreover, despite the well known benefits of the available synthetic and eterologue kit, their use may be limited by the high cost of these materials. At this proposal it can be suggested as alternative option the possibility to perform the procedure using an autologous tissue, i.e. rectus fascia, and reusable introductory needles. Based on these considerations the aim of this trial will be to compare autologous, synthetic and biological mesh for TOT in women with urinary stress incontinence.
|Stress Urinary Incontinence||Procedure: Autologous transobturator tape procedure Procedure: Synthetic transobturator tape procedure Procedure: Biological transobturator tape procedure||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Comparison in Terms of Efficacy and Safety Among Three Different Materials for Trans-obturator Correction of Urinary Stress Incontinence: Autologous, Synthetic and Biological Sling|
- Cure rate [ 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:||August 2012|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Procedure: Autologous transobturator tape procedure
A strip of rectus fascia is harvested. Small incision sites in the vagina and in the femoral/pelvic fold. Bilateral transobturator insertion of the autologous strip by means of reusable needles
Active Comparator: 2
Procedure: Synthetic transobturator tape procedure
Small incision sites in the vagina and in the femoral/pelvic fold. Bilateral transobturator insertion of synthetic mesh by means of mono-use needles.
Active Comparator: 3
Procedure: Biological transobturator tape procedure
Small incision sites in the vagina and in the femoral/pelvic fold. Bilateral transobturator insertion of biological mesh by means of mono-use needle
Women with genuine stress urinary incontinence will be enrolled and randomized in three groups (arm 1, arm 2, arm 3). All patients will be treated with a transobturatory approach, in patients of arm 1 will be used an autologous tissue and reusable introductory needles, in patients of arm 2 will be used a synthetic kit whereas in arm 3 will be a biological kit .
All eligible patients 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: NCT00744198
|Contact: Stefano Palomba, MDemail@example.com|
|Catanzaro, Italy, 88100|
|Contact: Ingrid Tomaino, MD 39-096-188-3234 firstname.lastname@example.org|
|Principal Investigator: Stefano Palomba, MD|
|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|