Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sa… (NCT04586166) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy
United States180 participantsStarted 2020-12-23
Plain-language summary
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.
Who can participate
Age range
21 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with subjectively bothersome stress incontinence
Timeframe: 6 weeks after surgery
2
Number of participants with subjectively bothersome stress incontinence
Timeframe: 1 year after surgery
3
Number of participants with subjectively bothersome stress incontinence
Timeframe: 3 years after surgery
4
Number of participants with subjectively bothersome stress incontinence