Comparing Minisling to Tension Free Vaginal Tape in Mangement of Stress Urinary Incontinence

Phase 2

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Procedure: tension free vaginal tape; Procedure: single incision minisling

• Registration Number: NCT02263534
• Lead Sponsor: Ain Shams University

Brief Summary

Based on previous studies the single incision minisling is an easy less invasive procedure with fewer complications and cure rate similar to conventional midurethral slings in the treatment of female stress urinary incontinence. The aim of this study is to test the hypothesis that the single incision mini-sling placed in the "U" position is not inferior to TVT in this patient population.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-20
• Study First Submitted QC: 2014-10-10
• Study First Posted: 2014-10-13
• Study Start: 2014-11-10
• Primary Completion: 2017-06
• Study Completion: 2017-10
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-18
• Last Update Posted: 2018-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

• Patients with urodynamic stress urinary incontinence, with or without pelvic organ prolapse

Exclusion Criteria

• Patients with overactive bladder on urodynamic study.
• Patients with voiding dysfunction.
• Patients with intrinsic sphincteric deficiency.
• Patients with previous anti-incontinence surgery.
• Patients on anti-coagulant therapy.
• Immune-compromised patients (DM, patients on corticosteroids treatment).
• Refusal of surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tension free vaginal tape	tension free vaginal tape	patients in this arm will undergo tension free vaginal tape
minisling	single incision minisling	patients in this arm will undergo single incision minisling

Primary Outcome Measures

Name	Time	Method
subjective cure rate of urinary incontinence at 12 months after surgery	12 months	subjective cure is indicated by an Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment for stress urinary incontinence
objective cure rate of urinary incontinence at 12 months after surgery	12 months	Objective cure is indicated by a negative stress test and the absence of any additional surgical or nonsurgical treatment for stress urinary incontinence

Secondary Outcome Measures

Name	Time	Method
Number of participants with long-term complications	12 months	long-term complications: erosion, dyspareunia and recurrence
Number of participants with short- term complications	12 months	short-term complications (less than 6 weeks): post-operative pain, urinary retention, denovo urgency and wound sepsis

Trial Locations

Locations (1)

Ain Shams University, Maternity Hospital; 🇪🇬 Cairo, Egypt