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 range22 Years
SexALL
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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…
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.