Single-Incision vs Retropubic Sling for Stress Urinary Incontinence

(SASS Trial)

Recruiting at 5 trial locations

Overseen By Catherine A Matthews, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Prior SUI surgery, Diabetes, Neurogenic bladder, Inflammatory bowel disease, others

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

Compensation: Varies

Number of Visits: 3

Duration: Surgery and immediate post-operative period

180 Participants Needed

Trial Summary

What is the purpose of this trial?

SASS (Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy) will be a multicenter, prospective, randomized, single-blind non-inferiority trial.

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

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What data supports the effectiveness of the treatment for stress urinary incontinence?

The retropubic midurethral sling is a well-established treatment for stress urinary incontinence, known for high cure rates and low complication rates. Single-incision slings like Solyx offer benefits such as shorter surgery times and quicker recovery, although they may not be as effective as traditional midurethral slings. ^{1 2 3 4 5}

Is the single-incision or retropubic sling safe for treating stress urinary incontinence?

The single-incision sling (SIS) and retropubic sling are generally considered safe for treating stress urinary incontinence, with studies showing low complication rates. However, there is a risk of complications like bladder perforation, which can lead to serious infections if not recognized during surgery. ^{1 2 4 6 7}

How does the single-incision sling treatment for stress urinary incontinence differ from other treatments?

The single-incision sling treatment for stress urinary incontinence is unique because it involves a less invasive procedure with a single incision, which can lead to shorter surgery times and quicker recovery compared to traditional retropubic or transobturator slings. However, it is still being evaluated for its long-term effectiveness compared to these established methods. ^{1 2 4 5 8}

Research Team

Catherine Matthews, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

Women over 21 with vaginal bulge symptoms, pelvic organ prolapse stage II or higher, and stress urinary incontinence are eligible. They must be able to consent, complete questionnaires, and return for follow-ups. Exclusions include neurogenic bladder issues, high post-void residuals, pregnancy plans, serious interfering conditions, unwillingness to have a synthetic sling, unresolved UTI's or poorly-controlled diabetes.

Inclusion Criteria

Able to give informed consent

Understanding and acceptance of the need to return for all scheduled follow-up visits and willing to complete study questionnaires

You have been diagnosed with stress urinary incontinence based on a positive cough stress test or urodynamic study showing reduced prolapse.

Exclusion Criteria

I have bladder issues not fixed by certain tests or devices.

My diabetes is not well-managed with an HgbA1c over 9.

I have a current issue with abnormal connections in my urinary tract.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either single-incision sling (SIS) or retropubic (RP) sling placement during minimally invasive sacrocolpopexy

Surgery and immediate post-operative period

1 visit (in-person for surgery)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple time points

5 years

Post Op: week 2, week 6, year 1, year 2, year 3, and year 5

Treatment Details

Interventions

• RP Sling
• SIS

Trial Overview The SASS trial is testing two surgical methods for treating stress urinary incontinence during minimally invasive sacrocolpopexy: the Single-incision Sling (SIS) versus the Retropubic Mid-Urethral Sling (RP Sling). It's a multicenter study where participants are randomly assigned to one of these treatments without knowing which one they receive.

Participant Groups

Group I: SIS Group Experimental Treatment 1 Intervention

Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure

Group II: RP Sling Group Experimental Treatment 1 Intervention

Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Boston Scientific Corporation

Industry Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Findings from Research

Retropubic midurethral slings are generally safe and effective for treating stress urinary incontinence, but complications like unrecognized bladder perforation can occur, leading to significant morbidity.

In this case, a 47-year-old patient developed severe cellulitis and fever after surgery, which was ultimately linked to an unrecognized bladder perforation, highlighting the need for careful monitoring and consideration of nonbacterial infections post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unrecognized bladder perforation leading to severe progressive cellulitis and candidal infection. Fenderson, JL., Washington, BB., Hampton, BS., et al.[2014]

Both adjustable (Ajust) and nonadjustable (Solyx) single-incision mini-slings (SIMS) were found to be safe and effective for treating urodynamic stress incontinence (USI), with similar subjective and objective cure rates after 12 months in a study of 60 patients.

Postoperative assessments showed significant improvements in patient-reported outcomes, with no major complications reported, indicating that both types of SIMS can be viable options for USI treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of adjustable and nonadjustable single-incision mini-slings in the treatment of female stress urinary incontinence: An initial experience with 30 cases. Liang, CC., Yueh-Hsia Chiu, S., Hsieh, WC.[2022]

In a study of 335 patients, those who had a retropubic midurethral sling (rMUS) placed during robotic sacrocolpopexy (RSC) had a significantly higher failure rate (8.6%) compared to those who had rMUS placed alone (2.3%).

Patients undergoing rMUS with RSC were 3.63 times more likely to require additional treatment for stress urinary incontinence, and hypertension was also linked to a fourfold increase in rMUS failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Failure Rate of Retropubic Midurethral Sling With and Without Concomitant Robotic Sacrocolpopexy. Rustia, GM., Baracy, MG., Drouillard, FJ., et al.[2022]

In a study of 63 women with stress urinary incontinence, 95% reported being dry after receiving the Solyx single-incision sling, indicating high efficacy of the treatment.

The procedure was found to be safe, with no serious complications reported, such as perforations or erosions, and only two cases of transient urinary retention that resolved on their own.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary findings with the Solyx single-incision sling system in female stress urinary incontinence. Serels, S., Douso, M., Short, G.[2021]

Synthetic midurethral slings have become the new gold standard for treating stress urinary incontinence (SUI) in women, as they are as effective as traditional surgical options but with fewer complications.

While retropubic midurethral slings show slightly higher success rates than transobturator slings, they also come with a higher risk of postoperative complications, making the choice of procedure important based on individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical management of female SUI: is there a gold standard? Cox, A., Herschorn, S., Lee, L.[2021]

In a study of 54 Turkish women with stress urinary incontinence, both retropubic (RP) and transobturator (TO) midurethral slings showed high efficacy, with objective cure rates of 92.6% and subjective cure rates of 79.6%.

The surgery significantly improved the quality of life for patients, and there was no notable difference in safety or efficacy between the RP and TO techniques, suggesting both methods are viable options for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of retropubic or transobturator midurethral slings in a randomized cohort of Turkish women. Tarcan, T., Mangir, N., Sahan, A., et al.[2014]

In a study of 92 women with stress urinary incontinence, the transobturator tape (TOT) sling showed a 93% objective cure rate compared to 100% for the retropubic (RP) sling, indicating that while TOT is effective, RP may have slightly better outcomes.

The study concluded that the TOT sling is noninferior to the RP sling in terms of cure rates, and both procedures significantly improved quality of life, although the RP group experienced higher rates of urinary retention post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective and randomized clinical trial comparing transobturator versus retropubic sling in terms of efficacy and safety. Palos, CC., Maturana, AP., Ghersel, FR., et al.[2018]

A systematic review of 55 studies revealed that complications from mid-urethral sling surgeries for stress urinary incontinence are more common than previously believed, including issues like bladder perforation, vaginal injury, and urinary tract infections.

Postoperative complications also included lower urinary tract symptoms, pain, and tape erosion, highlighting the need for improved long-term follow-up and safety measures in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focusing on long-term complications of mid-urethral slings among women with stress urinary incontinence as a patient safety improvement measure: A protocol for systematic review and meta-analysis. Lin, YH., Lee, CK., Chang, SD., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Unrecognized bladder perforation leading to severe progressive cellulitis and candidal infection. [2014]

2. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Comparison of adjustable and nonadjustable single-incision mini-slings in the treatment of female stress urinary incontinence: An initial experience with 30 cases. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Failure Rate of Retropubic Midurethral Sling With and Without Concomitant Robotic Sacrocolpopexy. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Preliminary findings with the Solyx single-incision sling system in female stress urinary incontinence. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Surgical management of female SUI: is there a gold standard? [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and efficacy of retropubic or transobturator midurethral slings in a randomized cohort of Turkish women. [2014]

7. England pubmed.ncbi.nlm.nih.gov

Prospective and randomized clinical trial comparing transobturator versus retropubic sling in terms of efficacy and safety. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Focusing on long-term complications of mid-urethral slings among women with stress urinary incontinence as a patient safety improvement measure: A protocol for systematic review and meta-analysis. [2023]