Study of 30-Minute Stimulation With the Neuspera Sacral Neuromodulation (SNM) System
ConditionUrinary Urge Incontinence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorNeuspera Medical, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Has a contraindication for the Neuspera SNM System per the device labeling.
Has a hemoglobin A1c of >8%.
Has glucosuria.
Has diabetic neuropathy.
Trial design
Treatments tested in this trial
- Neuspera Implantable Sacral Neuromodulation System
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov