Urinary Urgency IncontinenceNSM-005NCT07144813
Post-Approval Study of the Neuspera Sacral Neuromodulation System
A study testing Neuspera Implantable Sacral Neuromodulation System in people with Urinary Urgency Incontinence, run by Neuspera Medical, Inc. at 20 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Urinary Urgency Incontinence
- What is being tested?
- Neuspera Implantable Sacral Neuromodulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 20 sitesUnited States
- Study dates
- 3 Sep 2025to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects in the SANS-UUI Phase I or Phase II study
Who cannot join
- None
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
United States20 sites, 1 recruiting
- Recruiting
Urology Austin,
Austin, Texas, 78759
Brian Mazzarella, MD, (502)-569-7904
Michelle Valentin-Rivera, (502)-569-7904
- Active, not recruiting
MetroHealth System,
Cleveland, Ohio, 44109
- Active, not recruiting
UCNT Dallas,
Dallas, Texas, 75231
- Active, not recruiting
Women's Health Advantage,
Fort Wayne, Indiana, 46825
- Active, not recruiting
Indiana University, School of Medicine
Indianapolis, Indiana, 46202
- Active, not recruiting
University of Kansas Medical Center,
Kansas City, Kansas, 66160
- Active, not recruiting
University of Louisville Health System,
Louisville, Kentucky, 40202
- Active, not recruiting
Ochsner Medical
New Orleans, Louisiana, 70121
- Active, not recruiting
The Institute for Female Pelvic Medicine and Reconstructive Surgery,
North Wales, Pennsylvania, 19454
- Active, not recruiting
Adult & Pediatric Urology P.C
Omaha, Nebraska, 68114
- Active, not recruiting
Women's Healthcare Associates,
Portland, Oregon, 97225
- Active, not recruiting
Premier Medical Group,
Poughkeepsie, New York, 12603
- Active, not recruiting
Kaiser Permanente Point Loma MOB
San Diego, California, 92110
- Active, not recruiting
Genesis Healthcare Partners
San Diego, California, 92123
- Active, not recruiting
Virginia Mason Medical Center,
Seattle, Washington, 98101
- Active, not recruiting
Specialty Research of St. Louis
St Louis, Missouri, 63141
- Active, not recruiting
Florida Urology Partners
Tampa, Florida, 33615
- Active, not recruiting
Southern Urogynecology,
West Columbia, South Carolina, 29169
- Active, not recruiting
Minnesota Urology
Woodbury, Minnesota, 55125
- Active, not recruiting
University of Michigan Health
Wyoming, Michigan, 49519
About this study
Official title: Clinical Post- Approval Study of the Neuspera Sacral Neuromodulation (SNM) System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)
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.
Read the detailed description
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.
- Conditions
- Urinary Urgency Incontinence
- Being tested
- Neuspera Implantable Sacral Neuromodulation System
- Keywords
- UUI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuspera Implantable Sacral Neuromodulation SystemDevice
Stimulation of the Sacral Nerve.
| Study group | Role | What they receive |
|---|---|---|
| Neuspera Implantable Sacral Neuromodulation Stimulation System | Other | Long term follow-up for the FDA approved Neuspera Sacral Neuromodulation Stimulation system Receives: Device: Neuspera Implantable Sacral Neuromodulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
Incidence of device- and procedure-related AEs
Measured: Through 72 months
Primary Effectiveness Endpoint:
Percentage of all implanted subjects who experience an improvement in UUI episodes of at least 50% or more
Measured: Through 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start3 Sep 2025
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Urgency IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuspera Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Osvaldo Padron, MD, Principal investigator, Florida Urology Partners
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144813
- Sponsor's protocol ID
- Neuspera Medical (NSM-005)
- Acronym
- NSM-005
- Status last verified
- Feb 2026
- First submitted
- 25 Aug 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Post- Approval Study of the Neuspera Sacral Neuromodulation (SNM) System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)
- ClinicalTrials.gov ID
- NCT07144813
- Acronym / sponsor ID
- NSM-005 / Neuspera Medical (NSM-005)
- Conditions
- Urinary Urgency Incontinence
- Keywords
- UUI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Neuspera Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuspera Implantable Sacral Neuromodulation Stimulation System | Other | Device: Neuspera Implantable Sacral Neuromodulation SystemLong term follow-up for the FDA approved Neuspera Sacral Neuromodulation Stimulation system |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects in the SANS-UUI Phase I or Phase II study
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuspera Implantable Sacral Neuromodulation SystemStimulation of the Sacral Nerve. | Device | Neuspera Implantable Sacral Neuromodulation Stimulation System |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Neuspera Medical web pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Osvaldo Padron, MD principal investigator
Florida Urology Partners
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuspera Implantable Sacral Neuromodulation System in people with Urinary Urgency Incontinence, run by Neuspera Medical, Inc. at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Vollmer (408-433-3839, mark.vollmer@neuspera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: Through 72 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.