Trials / Completed
CompletedNCT02263534
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
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Ain Shams University · Academic / Other
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
| 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 |
Timeline
- Start date
- 2014-11-10
- Primary completion
- 2017-06-01
- Completion
- 2017-10-01
- First posted
- 2014-10-13
- Last updated
- 2018-09-19
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT02263534. Inclusion in this directory is not an endorsement.