What side effects are associated with this type of intervention?

Common surgical treatments for stress urinary incontinence, such as the Trans Vaginal Obturator Tape (TVT-O) and Mini-Arc Precise Pro, aim to improve urethral and bladder neck support. Known side effects of these procedures include urinary tract infections, temporary difficulty urinating, bladder perforation, and pain in the pelvic area. Some patients may also experience mesh erosion, which can lead to complications requiring further surgical intervention. Additionally, there may be risks of bleeding and adverse reactions to anesthesia.

What prior FDA approvals exist?

FDA-approved treatments for stress urinary incontinence (SUI) primarily include surgical interventions aimed at improving urethral and bladder neck support. Common surgical options are mid-urethral sling procedures, such as the transvaginal obturator tape (TVT-O) and mini-sling systems like the Mini-Arc Precise Pro. These procedures involve placing a supportive mesh under the urethra to prevent leakage during physical activities. While there are no specific FDA-approved drugs solely for SUI, some medications used off-label include duloxetine, which can increase urethral sphincter muscle tone.

What other types of research exist?

Promising novel alternatives to surgical interventions for stress incontinence include pelvic floor muscle training (PFMT), biofeedback, electrical stimulation, and the use of vaginal pessaries. These methods aim to strengthen the pelvic floor muscles and provide better support to the urethra and bladder neck, potentially reducing symptoms of stress incontinence.

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Sling

Urethral Sling Surgeries for Stress Urinary Incontinence

Phase 3

Waitlist Available

Research Sponsored by University of Manitoba

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women with stress urinary incontinence with a positive cough test

Be older than 18 years old

Must not have

Previous failed procedure

Voiding dysfunction (PVR>100 mL)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects from both surgeries may include pain at the incision site, bleeding, infection risk, temporary difficulty urinating post-surgery, and potential injury to surrounding organs during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman with urine leakage when I cough.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

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I have trouble emptying my bladder fully.

Select...

I have a vaginal prolapse more severe than stage 1.

Select...

I mainly have issues with bladder control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Active Control

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

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for stress incontinence, particularly surgical interventions, aim to improve urethral and bladder neck support. Procedures such as the Trans Vaginal Obturator Tape (TVT-O) and Mini-Arc Precise Pro involve the placement of a supportive mesh or sling under the urethra. This mesh acts as a hammock, providing additional support to the urethra and bladder neck, which helps to prevent urine leakage during activities that increase abdominal pressure, such as coughing or lifting. These treatments are crucial for stress incontinence patients as they directly address the underlying issue of weakened pelvic floor muscles and connective tissues, thereby significantly improving symptoms and quality of life.

Interventions for treating recurrent stress urinary incontinence after failed minimally invasive synthetic midurethral tape surgery in women.