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Autologous Versus Synthetic Versus Biological Sling for Trans-obturator Correction of Urinary Stress Incontinence

NCT00744198 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2013-04-08

No results posted yet for this study

Summary

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.

Conditions

  • Stress Urinary Incontinence

Interventions

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

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.

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

Sponsors & Collaborators

  • University Magna Graecia

    lead OTHER

Principal Investigators

  • Stefano Palomba, MD · Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

  • Fulvio Zullo, MD · Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-08-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00744198 on ClinicalTrials.gov