Study of 30-Minute Stimulation With the Neuspera Sacral Neuromodulation (SNM) System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)
Neuspera Medical, Inc.
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.
Description
The study is intended to investigate the potential for controlling UUI symptoms with thirty minutes of stimulation per day. Subjects will be enrolled in a single-arm study and followed for 6 months post implant. Subjects will undergo a trial stimulation period, followed by a permanent implant. If subjects do not receive appropriate benefits with the shorter duration of stimulation, they can increase the duration of stimulation anytime as needed. Subjects may also decrease stimulation after one month to 15 minutes per day if desired. Up to 30 subjects will be implanted.
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
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 blad…
Interventions
- DeviceNeuspera Implantable Sacral Neuromodulation System
Stimulation of the Sacral Nerve
Location
- Southern Urogynecology, LLCWest Columbia, South Carolina