Correction of Asymptomatic 2nd Degree Cystocele in Patient With Stress Incontinence

Phase 2

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Procedure: trans-obturator tape inside-out usingsoft tapes.; Procedure: anterior colporraphy

• Registration Number: NCT03296748
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

The aim of our study is to assess the value of concomitant surgical correction of asymptomatic grade II anterior vaginal wall prolapse with the placement of midurethral sling for treatment of female patients with stress incontinence

Detailed Description

female patients with stress urinary incontinence and asymptomatic grade II anterior vaginal wall prolapse were divided into Group A: treated only with trans-obturator tape (TOT) and group B where' TOT was associated with anterior colporrhaphy and the outcome is compared.

Study Timeline

• Study Start: 2016-06-01
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Study First Submitted: 2017-09-25
• Study First Submitted QC: 2017-09-27
• Study First Posted: 2017-09-28
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-23
• Last Update Posted: 2017-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 123

Inclusion Criteria

• female patients

• genuine stress incontinence

  • asymptomatic cystocele

Exclusion Criteria

• mixed incontinence

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TOT only group	trans-obturator tape inside-out usingsoft tapes.	60 patients with stress incontinence and asymptomatic grade 2 cystocele.
concomitant repair group	trans-obturator tape inside-out usingsoft tapes.	63 patients with stress incontinence and asymptomatic grade 2 cystocele.
concomitant repair group	anterior colporraphy	63 patients with stress incontinence and asymptomatic grade 2 cystocele.

Primary Outcome Measures

Name	Time	Method
cure rate of stress incontinence	3 months after surgery	by clinical assessment
Denovo urgency	3 months after surgery	by clinical assessment

Secondary Outcome Measures

Name	Time	Method
cure rate of stress incontinence	12 months after surgery	by clinical assessment
Denovo urgency	12 months after surgery	by clinical assessment

Trial Locations

Locations (1)

Kasr El Ainiy Hospital; 🇪🇬 Cairo, Egypt