TOT, TVT And Burch Colpo-Suspension for Treatment of Female Mixed Urinary Incontinence

Not Applicable

Completed

• Conditions: Treatment
• Interventions: Procedure: TVT; Procedure: TOT; Procedure: Burch Colposuspension

• Registration Number: NCT02775526
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-15
• Study First Submitted QC: 2016-05-16
• Study First Posted: 2016-05-17
• Status Verified: 2020-01
• Primary Completion: 2020-01-10
• Study Completion: 2020-01-10
• Last Update Submitted: 2020-01-26
• Last Update Posted: 2020-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TVT	TVT	TVT
TOT	TOT	TOT
Burch colposuspension	Burch Colposuspension	Burch colposuspension

Primary Outcome Measures

Name	Time	Method
subjective cure rate	2 years
objective cure rate	2 years

Trial Locations

Locations (1)

Ain Shams University Maternity Hospital; 🇪🇬 Cairo, Egypt