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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02263534
• Other study ID #: SIMS001
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 10, 2014
• Est. completion date: October 2017

Study information

• Verified date: September 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Ain Shams University, Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Number of participants with long-term complications	long-term complications: erosion, dyspareunia and recurrence	12 months