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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Neuspera Implantable Sacral Neuromodulation System
DeviceStimulation of the Sacral Nerve
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Neuspera Implantable Sacral Nerve Stimulation SystemOther 1 intervention
Trial outcomes
Primary outcomes
1
Primary Safety Endpoint- Proportion of Subjects experiencing a device- and/or procedure-related AEs
Proportion of Subjects experiencing a device- and/or procedure-related Adverse events
Time frame
6 months2
Primary Effectiveness Endpoint-Percentage of all implanted subjects who experience an improvement in UUI episodes.
Percentage of all implanted subjects who experience an improvement in UUI episodes of at least 50% or more, relative to the number of UUI episodes at baseline.
Time frame
1, 3 and 6 months post implantSponsors and contacts
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Source ClinicalTrials.gov