Desara ® One Single Incision Sling 522 Study (NCT04772131) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Desara ® One Single Incision Sling 522 Study
United States300 participantsStarted 2021-11-01
Plain-language summary
A post-market study to compare the safety and effectiveness of the Desara® One Single Incision Sling (SIS), when compared to that of an FDA cleared transobturator sling over a period of 36 months.
Who can participate
Age range
18 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
. Female ≥ 18 of age.
. Subject agrees that she is willing and able to return for all study related procedures and evaluations.
. Subject has provided signed informed consent.
. Subject has stress urinary incontinence (SUI) confirmed by either supine or standing cough stress test (CST) with bladder pre-fill to subjective fullness with 200-300 mL, or with bladder fullness confirmed via ultrasound.
. Subject has confirmed stress incontinence greater than urge incontinence per MESA questionnaire.
. Subject no longer has childbearing capacity or has a negative pregnancy test and has decided to cease childbearing. Childbearing capacity to be confirmed by documented history of:
. A hysterectomy or
. Tubal ligation or
Exclusion criteria
. Subject reports baseline pelvic pain ≥ 2 on 10 point Numeric Rating Scale (NRS).
. Subject has a known neurological disease (with or without signs/symptoms of neurogenic bladder).
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
Success rate of negative standing cough stress test (CST)
Timeframe: 36 months
2
Device and Procedure-related serious adverse events
. Subject has known pre-existing pain syndrome and/or has been evaluated by an interventional pain management physician.
. Subject has a history of chronic opioid, or narcotic use for:
. pain or
. any other specified reason
. Subject is on anti-coagulation therapy that cannot be suspended or adjusted for a minimum of 24-48 hours prior to planned sling implantation surgery.
. Subject is on chronic (\> 3 months) systemic steroid treatment (except for inhalational use as indicated for pulmonary conditions).