Autologous Versus Synthetic Versus Biological Sling for Trans-obturator Correction of Urinary Stress Incontinence
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00744198|
Recruitment Status : Unknown
Verified April 2013 by Stefano Palomba, University Magna Graecia.
Recruitment status was: Recruiting
First Posted : August 29, 2008
Last Update Posted : April 8, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Stress Urinary Incontinence||Procedure: Autologous transobturator tape procedure Procedure: Synthetic transobturator tape procedure Procedure: Biological transobturator tape procedure||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||August 2014|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00744198
|Contact: Stefano Palomba, MDfirstname.lastname@example.org|
|Catanzaro, Italy, 88100|
|Contact: Ingrid Tomaino, MD 39-096-188-3234 email@example.com|
|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|