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

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

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.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Procedure: single incision minisling; Procedure: tension free vaginal tape

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University, Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: minisling; patients in this arm will undergo single incision minisling	Procedure: single incision minisling; midline incision of the vagina at midurethral level dissection of the vagina from perivesical fascia insertion of the tape (polypropylene macropore mesh tape) in the retropubic direction with its end grasped with an artery forceps till level of perineal membrane closure of the vagina 2 sham incisions if the skin only will be made at suprapubic to maintain blindness posterior colpoperneorraphy will be carried out if needed
Sham Comparator: tension free vaginal tape; patients in this arm will undergo tension free vaginal tape	Procedure: tension free vaginal tape; midline incision of the vagina at midurethral level dissection of the vagina from perivesical fascia insertion of the tape (polypropylene macropore mesh tape) with the applicators in the retropubic direction and 2 skin incision will be made supra pubic through which the applicators will be passed and removed and the tape will be cut at level just below the skin closure of the vagina posterior colpoperneorraphy will be carried out if needed; Other Names: TVT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
objective cure rate of urinary incontinence at 12 months after surgery	Objective cure is indicated by a negative stress test and the absence of any additional surgical or nonsurgical treatment for stress urinary incontinence	12 months
subjective cure rate of urinary incontinence at 12 months after surgery	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	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: ahmed reda, M.Sc, AIN shams university

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2014
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: August 20, 2014
• First Submitted That Met QC Criteria: October 10, 2014
• First Posted (Estimate): October 13, 2014

Study Record Updates

• Last Update Posted (Actual): September 19, 2018
• Last Update Submitted That Met QC Criteria: September 18, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: stress urinary incontinence; midurethral sling; tension free vaginal tape; single incision minisling
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: SIMS001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED