Trans-Obturator Tape, Tension-Free Vaginal Tape and Burch Colposuspension for Treatment of Female Mixed Urinary Incontinence: A Randomized Clinical Trial

Ain Shams University1 site in 1 country220 target enrollmentMay 2016

ConditionsTreatment

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Treatment
Sponsor: Ain Shams University
Enrollment: 220
Locations: 1
Primary Endpoint: subjective cure rate
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This prospective interventional randomized controlled trial will recruit women with MUI scheduled for surgical treatment where patients will be randomized to either Burch colposuspension, TOT or TVT. Regular postoperative follow up will be planned for at least 2 years. The primary outcome measures will be the objective and subjective cure rates.

Registry

clinicaltrials.gov

Start Date

May 2016

End Date

January 10, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Ain Shams University

Responsible Party

Principal Investigator

Mohamed S Sweed, MD

Ain Shams University

Eligibility Criteria

Inclusion Criteria

•Women with mixed urinary incontinence.

Exclusion Criteria

•Women with associated gynecological surgery e.g. uterine prolapse, previous anti-incontinence surgery, intrinsic sphincter deficiency (ISD), and medical disorders affecting the bladder innervation as diabetes mellitus were excluded from the study.
•Women who improved on medical treatment with persistence of stress element only were also excluded.