Mesh-Reduced Sling for Stress Urinary Incontinence

Overseen By Henry Chill, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Endeavor Health

Disqualifiers: Childbearing age, Previous SUI surgery

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

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new surgical technique for treating stress urinary incontinence (SUI) in women. The focus is on a mesh-reduced sling, a surgical implant designed to improve symptoms by supporting the urethra. Researchers aim to determine if this method is safe and effective in reducing SUI symptoms and addressing key support issues. Women with noticeable SUI symptoms who haven't had previous surgery for this condition might be suitable candidates. Participants will undergo surgery and be monitored for up to a year to assess the treatment's effectiveness. As an unphased trial, this study allows participants to contribute to pioneering research that could lead to innovative SUI treatments.

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 mesh-reduced suture-based surgical technique is safe for treating stress urinary incontinence?

Research has shown that midurethral mesh slings, similar to the new mesh-reduced sling under study, are generally safe for treating stress urinary incontinence (SUI). Studies have found that single-incision slings, which share a similar design, have a low rate of complications in the medium term. Although common issues like pain and mesh exposure can occur, they are infrequent.

Long-term evidence indicates that midurethral slings are a standard surgical option for SUI, and most patients tolerate them well. However, certain factors, such as a history of hormone replacement therapy, might increase the risk of complications like difficulty urinating.

Overall, while some side effects are possible, the available data suggest these slings are generally safe for many women. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The mesh-reduced sling is unique because it aims to improve stress urinary incontinence (SUI) symptoms using less mesh material than traditional sling options. While current treatments often rely on a full mesh sling to support the urethra, this innovative approach reduces the amount of mesh, potentially minimizing complications associated with mesh implants, such as erosion or discomfort. Researchers are excited about this treatment because it could offer a safer alternative for women, with the promise of maintaining effectiveness in improving SUI symptoms while reducing side effects.

What evidence suggests that this mesh-reduced sling is effective for stress urinary incontinence?

Studies have shown that single-incision mini-slings for stress urinary incontinence (SUI) perform as well as standard midurethral slings, with patients reporting similar success rates after 15 months. Other research indicates that the C-NDL procedure, another mini-sling type, achieves high cure rates and few complications in the short term. These findings suggest that the mesh-reduced sling tested in this trial, a type of mini-sling, could effectively improve SUI symptoms. The mesh-reduced design aims to provide the benefits of traditional slings while potentially reducing mesh-related complications. Overall, these findings offer hope for effective symptom relief with fewer risks. ^{1 2 4 6 7}

Who Is on the Research Team?

Henry Chill, MD

Principal Investigator

Endeavor Health

Are You a Good Fit for This Trial?

This trial is for women with stress urinary incontinence, which means they leak urine under pressure like coughing or lifting. It's not for women who can still have children (ages 0-45) or those who've had surgery for this issue before.

Inclusion Criteria

I experience urine leakage when I cough, sneeze, or exercise.

Exclusion Criteria

I am a woman aged between 0 and 45.

I have had surgery for stress urinary incontinence before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-operative Assessment

Participants complete pre-operative assessments according to routine clinical pathway

1-2 weeks

1 visit (in-person)

Surgery

Participants undergo the mesh-reduced sling surgery for treating stress urinary incontinence

1 day

1 visit (in-person, hospital stay)

Postoperative Care

Standard postoperative care with discharge on the same day or after a brief hospital stay

1-2 days

Follow-up

Participants are monitored for safety and effectiveness after treatment with visits at 2 weeks, 2 months, and 12 months

12 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Mesh-reduced Sling

Trial Overview The study tests a new surgical technique using a mesh-reduced sling to treat stress urinary incontinence. Women will be assessed before and up to one year after the operation, including symptom checks and pelvic exams.

How Is the Trial Designed?

Group I: Mesh-reduced Sling Experimental Treatment 1 Intervention

Mesh-reduced sling will improve stress urinary incontinence (SUI) symptoms in women with SUI and normal urethral closure pressure at 2 months and 12 months after surgery.

Who Is Running the Clinical Trial?

Endeavor Health

Lead Sponsor

Trials

135

Recruited

742,000+

NorthShore University HealthSystem

Lead Sponsor

Trials

134

Recruited

740,000+

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

Long-term safety of mid-urethral sling for stress urinary ... Secondary outcomes were the cumulative incidence of MUS removal and section, hospitalization for urinary retention and MUS erosion and infection ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12152813/

Evaluation of the efficacy of mini-sling in the treatment ... The C-NDL procedure is a safe and effective method with few complications and high subjective cure rates on short-term follow-up (6 months).

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2111815

Single-Incision Mini-Slings for Stress Urinary Incontinence ... Single-incision mini-slings were noninferior to standard midurethral slings with respect to patient-reported success at 15 months.

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

Predictors and outcomes of Mid-urethral sling continence ... In this review we collated published data on MUS surgery performed among Taiwanese women with SUI in search for the best techniques and its outcome.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2667164622000276

Medium-term clinical efficacy and safety of single incision ... Single incision slings, Altis and Solyx, appear comparable to transobturator sling over medium-term follow-up, with a low rate of complications.

7. 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.