Study of 30-Minute Stimulation With the Neuspera Sacral Neuromodulation (SNM) System
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 Sys
| Condition(s) | Urinary Urge Incontinence |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 | 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-h |
| Ages | 22 Years |
| Sex | All |
| Lead sponsor | Neuspera Medical, Inc. |
| Locations | West Columbia, South Carolina, United States |
| Start date | 2025-11-19 |
| NCT ID | NCT07247136 |
| Official listing | https://clinicaltrials.gov/study/NCT07247136 |