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

Study Overview
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Brief Summary
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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.

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

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Procedure: single incision minisling
* Procedure: tension free vaginal tape


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: minisling<br>patients in this arm will undergo single incision minisling | Procedure: single incision minisling<br>* 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<br>|
| Sham Comparator: tension free vaginal tape<br>patients in this arm will undergo tension free vaginal tape | Procedure: tension free vaginal tape<br>* 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<br>* Other names: TVT;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stress urinary incontinence, tension free vaginal tape, single incision minisling, midurethral sling