Neuspera Implantable Sacral Neuromodulation System
DeviceStimulation of the Sacral Nerve.
Recruiting
NCT Number: NCT07144813
Post-Approval Study of the Neuspera Sacral Neuromodulation System
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
22 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Genesis Healthcare Partners, San Diego, California, United States
Loading trial locations.
About this study
The Neuspera SNM System received FDA PMA approval for the treatment of urinary urge incontinence in subjects who have failed, could not tolerate, or were not a candidate for more conservative treatment. The study will serve as the Post Approval Study (PAS) requirement of the PMA Approval.
This post approval study (PAS) is designed to assess the long-term safety and effectiveness data out to 72 months post-implant, in consenting subjects implanted in Phase I or Phase II study.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Subjects in the SANS-UUI Phase I or Phase II study
Exclusion criteria
- None
Treatment and study plan
Primary outcomes
-
Primary Safety Endpoint
Time frame: Through 72 months
Incidence of device- and procedure-related AEs
-
Primary Effectiveness Endpoint:
Time frame: Through 72 months
Percentage of all implanted subjects who experience an improvement in UUI episodes of at least 50% or more
Study contacts
Contact information is provided by the study sponsor or research team.
Mark Vollmer
CONTACT
Shital Patel
CONTACT
Sponsors and collaborators
Lead sponsor
Neuspera Medical, Inc.
Industry
Registry information
Official study title
Clinical Post- Approval Study of the Neuspera Sacral Neuromodulation (SNM) System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)
Acronym: NSM-005
Important dates
- Study start
- 2025
- Primary completion
- 2029
- Study completion
- 2029
- First posted
- Aug 28, 2025
- Registry last updated
- Feb 4, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Recruiting
Sacral Neuromodulation for Male Overactive Bladder (MOAB)
NCT06511141
Benign Prostatic Hyperplasia, Female Urogenital Diseases
Birmingham, Alabama, United States
View Trial Details
Active, Not Recruiting
Neuspera's Implantable Sacral Nerve Stimulation System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)
NCT04232696
Urinary Urgency Incontinence
Encinitas, California, United States
View Trial Details
Completed
Examining Bladder Control Using Mindful Based Approach
NCT01843543
Urinary Urgency Incontinence
Portland, Oregon, United States
View Trial Details