Comparing two types of slings for treating urinary incontinence during pelvic surgery
SASS: Randomized Trial of Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for Concomitant Management of Stress Urinary Incontinence During Minimally Invasive Sacrocolpopexy
This study is testing whether a new type of sling used during pelvic surgery works just as well as a traditional sling for treating urinary incontinence in women with pelvic organ prolapse.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 21 Years and up |
| Sex | Female |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Drugs / interventions | radiation |
| Locations | 7 sites (Coconut Creek, Florida and 6 other locations) |
| Trial ID | NCT04586166 on ClinicalTrials.gov |
What this trial studies
This trial, known as SASS, is a multicenter, prospective, randomized, single-blind non-inferiority trial that aims to evaluate the effectiveness of a single-incision sling versus a retropubic mid-urethral sling during minimally invasive sacrocolpopexy in women with pelvic organ prolapse and stress urinary incontinence. Participants will be women aged 21 and older who exhibit specific symptoms and conditions related to pelvic floor disorders. The study will involve surgical interventions and follow-up assessments to determine the outcomes of each sling type.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 21 and older with pelvic organ prolapse and objectively confirmed stress urinary incontinence.
Not a fit: Patients who have previously undergone surgery for stress urinary incontinence or have serious chronic conditions that could interfere with study compliance may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective surgical approach for treating stress urinary incontinence in women, potentially improving patient outcomes.
How similar studies have performed: Other studies have explored similar surgical approaches, but this specific comparison of single-incision versus retropubic slings during sacrocolpopexy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * At least 21 years of age * Vaginal bulge symptoms as indicated by an affirmative response of \>1 to question 3 of the PFDI-SF20 * POP ≥ stage II according to the pelvic organ prolapse quantification (POP-Q) system45, with evidence of apical descent * Women being considered for minimally invasive sacrocolpopexy (with or without concomitant hysterectomy) * Objective SUI: positive standardized cough stress test on clinical examination or on urodynamic study with reduced prolapse * Understanding and acceptance of the need to return for all scheduled follow-up visits and willing to complete study questionnaires * Able to give informed consent Exclusion Criteria: * Prior surgery for stress urinary incontinence including mid-urethral sling; Burch/MMK; fascial pubovaginal sling (autologous, xenograft or allograft); and urethral bulking injection * Any serious disease, or chronic condition, that could interfere with the study compliance * Unwilling to have a synthetic sling * Untreated and unresolved urinary tract infection * Poorly-controlled diabetes mellitus (HgbA1c \> 9 within 3 months of surgery date) * Neurogenic bladder/ pre-operative self-catheterization * Elevated post-void residual/PVR (\>150 ml) that does not resolve with prolapse reduction testing (pessary, prolapse reduced uroflow or micturition study) * Prior pelvic radiation * Inflammatory bowel disease * Current genitourinary fistula or urethral diverticulum * Planned concomitant bowel related surgery including sphincteroplasty and perineal rectal prolapse surgery, rectovaginal fistula repair, hemorrhoidectomy * Pregnant or Planning to Conceive * Incarcerated
Where this trial is running
Coconut Creek, Florida and 6 other locations
- Florida Robotic and Minimally Invasive Urogynecology — Coconut Creek, Florida, United States (Active_not_recruiting)
- Augusta University — Augusta, Georgia, United States (Recruiting)
- Northwestern Medicine — Chicago, Illinois, United States (Active_not_recruiting)
- University of Chicago — Chicago, Illinois, United States (Recruiting)
- Boston Urogynecology Associates — Cambridge, Massachusetts, United States (Recruiting)
- Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States (Recruiting)
- Pelvic Floor Foundation of South Africa, University of Cape Town — Cape Town, South Africa (Suspended)
Study contacts
- Principal investigator: Catherine A Matthews, MD — Wake Forest University Health Sciences
- Study coordinator: Sachin N Vyas, MS,PhD
- Email: svyas@wakehealth.edu
- Phone: 336-713-4098
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.