Study of 30-Minute Stimulation With the Neuspera Sacral Neuromodulation (SNM) System (NCT07247136) | Clinical Trial Compass
RecruitingNot Applicable
Study of 30-Minute Stimulation With the Neuspera Sacral Neuromodulation (SNM) System
United States30 participantsStarted 2025-11-19
Plain-language summary
Single-arm study conducted in participants for the treatment of urinary urge incontinence in patients who have failed, could not tolerate, or were not a candidate for more conservative treatments.
The objective of the study is to assess the effectiveness of 30-minutes daily therapeutic stimulation with the Neuspera System.
Who can participate
Age range
22 Years
Sex
ALL
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:
* Is male or female 22 years of age or older.
* Has a diagnosis of UUI for greater than or equal to 6 months prior to the screening baseline visit date.
* Has failed, could not tolerate (stopped taking medication due to lack of efficacy or intolerable side effects), or not a good candidate for (as determined by treating physician) at least one (1) antimuscarinic or β3 adrenoceptor agonist medication.
* Is willing and able to washout (at least five half-lives) from OAB medications for a period determined appropriate based on type of OAB medication prior to the baseline bladder diary and remain off OAB medications through the study duration OR must be willing to maintain medication through the study duration.
* Has a diagnosis of UUI with at least 4 UUI episodes on a 72-hour diary.
* Has a positive stimulation trial with a 50% reduction in UUI episodes.
Exclusion Criteria:
* Has a contraindication for the Neuspera SNM System per the device labeling.
* Has a hemoglobin A1c of \>8%.
* Has glucosuria.
* Has diabetic neuropathy.
* Has interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines, chronic pelvic pain, or recurrent symptomatic urinary tract infections.
* Has skin, orthopedic, neurological, or hematological (bleeding disorder) or anatomical limitations that could prevent successful placement of the neurostimulator.
* Has broken, blistered skin or comp…
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
Primary Safety Endpoint- Proportion of Subjects experiencing a device- and/or procedure-related AEs
Timeframe: 6 months
2
Primary Effectiveness Endpoint-Percentage of all implanted subjects who experience an improvement in UUI episodes.