Urethral Sling Surgeries for Stress Urinary Incontinence

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: University of Manitoba

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial compares two types of surgeries to find out which one is better for women who have trouble controlling their bladder during physical activities. The surgeries help by supporting the bladder or urethra to stop urine leakage.

Eligibility Criteria

This trial is for women who have stress urinary incontinence confirmed by a cough test and want surgery. It's not suitable for those with mostly overactive bladder symptoms, past unsuccessful treatments, weak urethral closure pressure, significant vaginal prolapse beyond stage 1, or difficulty emptying their bladder fully.

Inclusion Criteria

I am a woman with urine leakage when I cough.

Exclusion Criteria

I have had a treatment or procedure that did not work.

I have trouble emptying my bladder fully.

I have a vaginal prolapse more severe than stage 1.

I mainly have issues with bladder control.

Participant Groups

The study is comparing two surgical procedures to treat female stress urinary incontinence: the Mini-Arc Precise Pro sling and the Trans Vaginal Obturator Tape (TVT-O). Women will be randomly assigned to one of these surgeries.

1Treatment groups

Active Control

Group I: Precise sling vs TVT-O slingActive Control1 Intervention