Midurethral Sling Timing for Stress Incontinence

Overseen By Gabriela E Halder, MD, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Prior SUI surgery, Bladder issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: Surgery day

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best time to place a midurethral sling, a small mesh that helps with stress urinary incontinence, which occurs when urine leaks during actions like coughing or laughing. Surgeons insert the sling during robotic sacrocolpopexy, a procedure that corrects pelvic organ prolapse, a condition where organs like the bladder drop out of place. Researchers aim to determine whether placing the sling before or after the main part of the surgery better reduces symptoms and improves recovery. The trial suits those with pelvic organ prolapse who plan to undergo this specific surgery and experience stress urinary incontinence. As an unphased trial, it offers a unique opportunity to contribute to understanding the optimal timing for sling placement, potentially improving surgical outcomes for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this midurethral sling placement is safe for treating stress urinary incontinence?

In a previous study, the midurethral sling, a small mesh used to treat stress urinary incontinence, demonstrated a low risk for complications. Across more than 45 studies, the chance of requiring another surgery due to complications ranged from 0% to 19% within five years, often due to issues like mesh exposure. Another study found that after 15 years, only about 7.9% of patients needed their sling adjusted or replaced. These findings suggest that the sling is generally safe and well-tolerated by most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the optimal timing for placing a midurethral sling during robotic sacrocolpopexy procedures to treat stress urinary incontinence. Most current treatments, like midurethral sling placement alone or alternative surgical methods, don't consider the sequencing of procedures, which might affect outcomes. By investigating whether placing the sling before or after the robotic sacrocolpopexy makes a difference, this trial aims to find the most effective approach for reducing incontinence and enhancing recovery. This could lead to improved patient outcomes and more tailored surgical strategies.

What evidence suggests that this trial's treatments could be effective for stress urinary incontinence?

Research has shown that midurethral slings are a common and effective treatment for stress urinary incontinence (SUI), which occurs when urine leaks during activities like coughing or exercising. Studies have found that about 84% of patients stop leaking urine after sling surgery. These slings are as effective as other, more invasive surgeries. Over a 36-month period, mini-slings, a type of midurethral sling, have demonstrated similar success. Although some concerns exist about long-term results, the sling remains a top treatment for SUI. In this trial, participants will receive a midurethral sling either before or after robotic sacrocolpopexy to evaluate how timing affects effectiveness. ^{2 4 6 7 8}

Who Is on the Research Team?

Gabriela E Halder, MD, MPH

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for individuals with stress urinary incontinence and pelvic organ prolapse, planning to undergo robotic sacrocolpopexy. Participants should not have other conditions that could interfere with the study or outcomes.

Inclusion Criteria

I am 18 years old or older.

I plan to have surgery for urinary incontinence at the same time as my pelvic organ prolapse surgery.

I have experienced urinary incontinence in the past year.

Exclusion Criteria

My bladder holds less than 200 mL or doesn't empty well, leaving over 150 mL.

I am under 18 years old.

I have not been diagnosed with stress urinary incontinence.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo retropubic midurethral sling placement at the time of robotic-assisted sacrocolpopexy, randomized to receive the sling before or after sacrocolpopexy

Surgery day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at 6 weeks and 3 months postoperative

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Midurethral Sling Placement

Trial Overview The study investigates the optimal timing for placing a midurethral sling during robotic sacrocolpopexy surgery—either before or after lifting organs affected by prolapse—to determine which sequence offers better patient satisfaction and symptom improvement.

How Is the Trial Designed?

Group I: Midurethral sling placed after robotic sacrocolpopexy Active Control 1 Intervention

Group II: Midurethral sling placed before robotic sacrocolpopexy Active Control 1 Intervention

Midurethral sling placed after robotic sacrocolpopexy

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9169553/

Long-term outcomes following midurethral mesh sling ... Although midurethral mesh slings are the gold standard surgery for stress urinary incontinence (SUI), limited data exist regarding long-term outcomes.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1028455924002298

Predictors and outcomes of Mid-urethral sling continence ... Landmark paper by Wang et al., 1998 showed 84% continence achieved after a vaginal tape surgery, comparable to other invasive surgery [7] has open the way for ...

3. journals.lww.com journals.lww.com/md-journal/fulltext/2024/01120/midurethral_sling_position_and_surgical_outcome__a.33.aspx

Midurethral sling position and surgical outcome Studies focused on evaluating the effectiveness and complications of midurethral sling for female stress urinary incontinence. 2. Clinical ...

4. fda.gov fda.gov/medical-devices/urogynecologic-surgical-mesh-implants/stress-urinary-incontinence-surgical-mesh-considerations-and-recommendations

Stress Urinary Incontinence: Surgical Mesh Considerations ... The completed 522 studies demonstrate that mini-slings have comparable effectiveness to mid-urethral slings over a 36-month timeframe. The mini- ...

5. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2708113

Long-term Rate of Mesh Sling Removal Following ... This cohort study of women who underwent midurethral sling insertion for stress urinary incontinence at hospitals in England between 2006 and 2015.

6. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00343-8/fulltext

Long-term safety of mid-urethral sling for stress urinary ... In the 45 studies analyzed, the results were heterogeneous across studies: the rate of reoperation ranged from 0% to 19% at 5 years and 0%–17% ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211525001010

Efficacy and safety of repeated synthetic mid-urethral sling ... Repeated mid-urethral sling is effective and safe for recurrent stress incontinence treatment. No difference was found between primary or repeated sling.

8. nature.com nature.com/articles/s41598-023-48558-8

Risk factors for 5-year complications after midurethral sling ... Our findings suggest that a medication history of HRT may be a risk factor associated with surgical complications, especially urinary retention, at 5 years.