Post-Approval Study of the Neuspera Sacral Neuromodulation System
ConditionUrinary Urgency Incontinence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorNeuspera Medical, Inc.
About this trial
Prospective, multi-center, single-arm, post-approval study is designed to assess the long-term safety and efficacy data of the Neuspera Sacral Neuromodulation (SNM) System following commercial approval of the Neuspera SNM System.
Participants in this study received intervention/implanted in Phase I or Phase II of the Neuspera SANS\_UUI (NSM-004) Study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects in the SANS-UUI Phase I or Phase II study
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Neuspera Implantable Sacral Neuromodulation System
DeviceStimulation of the Sacral Nerve.
Treatment groups
116 Participants
are divided into 1 treatment groupGroup A: Neuspera Implantable Sacral Neuromodulation Stimulation SystemOther 1 intervention
Trial outcomes
Primary outcomes
1
Primary Safety Endpoint
Incidence of device- and procedure-related AEs
Time frame
Through 72 months2
Primary Effectiveness Endpoint:
Percentage of all implanted subjects who experience an improvement in UUI episodes of at least 50% or more
Time frame
Through 72 monthsSponsors and contacts
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Source ClinicalTrials.gov