Neuspera Medical, Inc.
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.
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.
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…
Stimulation of the Sacral Nerve
Arctuva estimate
Verify or correct the compensation shown for this listing.