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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-10

Study Completion Date

2017-10-31

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.

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Detailed Description

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Conditions

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Stress Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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minisling

patients in this arm will undergo single incision minisling

Group Type EXPERIMENTAL

single incision minisling

Intervention Type PROCEDURE

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

patients in this arm will undergo tension free vaginal tape

Group Type SHAM_COMPARATOR

tension free vaginal tape

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Other Intervention Names

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TVT

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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No