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Laparoscopic Burch Colposuspension Versus Transobturatory Tape for the Treatment of Female Urinary Stress Incontinence

NCT00573703 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2013-04-08

No results posted yet for this study

Summary

Transobturatory tape (TOT) procedure is a minimally invasive approach to urinary stress incontinence owing to the category of the sling-adopting procedures. Its efficacy and safety, also in comparison with similar procedures have been demonstrated. The benefits of the sling- adopting procedures in comparison to laparoscopic Burch colposuspension, which has been considered as the gold standard treatment, have been showed. But these comparisons did not included the TOT procedure in the experimental arms. Based on this considerations the aim of this trial will be to compare TOT and laparoscopic Burch colposuspension in women with urinary stress incontinence.

Conditions

  • Stress Urinary Incontinence

Interventions

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.

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.

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
2007-09-30
Primary Completion
2007-12-31

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 NCT00573703 on ClinicalTrials.gov