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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two surgical methods for treating stress urinary incontinence (SUI), a condition where urine leaks during activities like coughing or exercising. The trial tests whether a single-incision sling (SIS) is as effective as a retropubic sling (RP Sling) in managing SUI. It seeks women with symptoms of a vaginal bulge, diagnosed with SUI, and considering minimally invasive surgery to support the pelvic organs. Participants must be willing to adhere to the trial schedule and complete the necessary questionnaires. As an unphased trial, this study allows participants to contribute to important research that may enhance future treatment options for SUI.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study showed that single-incision slings (SIS), such as the Solyx, had a low rate of complications over the medium term. Most patients did not experience major problems after receiving the sling. Safety checks focused on serious issues like organ damage, which were rare.

Research has indicated that the retropubic (RP) sling also maintains a good safety record. One study found that after 9 years, only 3.3% of patients required sling removal, suggesting that problems remain uncommon over time. Another study demonstrated significant symptom improvement for many patients, with few long-term issues.

Both SIS and RP slings appear well-tolerated and safe for treating stress urinary incontinence. Studies have shown they are effective, with few serious adverse events reported. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for stress urinary incontinence because they offer potentially less invasive options compared to the traditional retropubic sling procedure. The single-incision sling (SIS) is unique as it requires only one small incision, which may lead to quicker recovery and less post-operative pain for patients. On the other hand, the retropubic (RP) sling remains a valid option, typically known for its effectiveness and durability. By comparing these two techniques, researchers hope to determine if the SIS can match or exceed the RP sling's benefits while offering a more patient-friendly experience.

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

This trial will compare the effectiveness of the Solyx single-incision sling (SIS) and the retropubic (RP) sling for treating stress urinary incontinence (SUI). A previous study showed that the SIS achieved better results than other sling types, with more patients cured and fewer requiring additional surgery. Research indicates that SIS is as effective as traditional methods but less invasive, with patients reporting positive experiences.

For the RP sling, studies have shown it is equally effective in treating SUI as other mid-urethral slings, maintaining consistent cure rates over time. A comparison study found the RP sling to be as effective as the single-incision sling, making both options viable for managing SUI symptoms. Participants in this trial will be assigned to either the SIS group or the RP sling group to further evaluate these findings. ^{5 6 7 8 9}

Who Is on the Research Team?

Catherine Matthews, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39344604/

Comparison of Surgical Outcomes of Autologous Mid ... Overall, both types of slings had similar cure rates but AFSs were associated with longer operative times. The study highlights the need for ...

2. 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.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04586166

NCT04586166 | Single-incision Versus Retropubic Mid- ... SASS aims to compare the efficacy of a single-incision (SIS) versus a retropubic mid-urethral sling (RP) placed at the time of minimally invasive ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40010159/

Efficacy and safety of repeated synthetic mid-urethral sling ... rMUS is a highly effective and safe option for women with rSUI. Its excellent effectiveness, comparable to that of pMUS, and the lack of ...

5. ajog.org ajog.org/article/S0002-9378(24)00562-3/fulltext

A randomized trial of retropubic vs single-incision sling ... For women undergoing vaginal repair, single-incision was noninferior to retropubic sling for stress urinary incontinence symptoms, and ...

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

Long-term safety of mid-urethral sling for stress urinary ... Long-term safety of mid-urethral sling for stress urinary incontinence in women: an emulated trial using French national health data system.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4272663/

5-Year Longitudinal Follow-up after Retropubic and ... We report 5-year outcomes, including treatment success, satisfaction, urinary symptoms, QOL, and adverse events in women who completed Trial of Mid-urethral ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0301211525003860

Long-term outcome of the retropubic TVT procedure for ... Retropubic TVT shows durable efficacy for stress urinary incontinence after 20–25 years. 76.3% of patients report significant long-term improvement in symptoms.

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

Long-term Rate of Mesh Sling Removal Following ... Among women undergoing midurethral mesh sling insertion, the rate of mesh sling removal at 9 years was estimated as 3.3%.