Urinary Urge IncontinenceNCT07383688
Neuspera Revision Registry - Follow up Revision Experience and Evaluation of Device Outcomes Metrics
An observational study of Urinary Urge Incontinence, run by Neuspera Medical, Inc. at 1 site in United States.
Trial summary
Single-arm study where subjects' responses to a questionnaire for the traditional Sacral Neuromodulation (SNM) devices will be compared to the responses regarding the Neuspera SNM System. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Urinary Urge Incontinence
- What is being tested?
- Neuspera Implantable Sacral Neuromodulation System
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to Apr 2027
- Phase
- Observational
- 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
Study population: Study population with 22 years of age or older and who have or have previously had a traditional SNM system.
Who may be able to join
- Currently have a traditional SNM device and has decided to have the device replaced with the Neuspera SNM System OR previously had an existing traditional SNM implant that was completely removed within the last year
- Is 22 years of age or older
- Had documented at least 50% improvement in UUI episodes on a bladder diary with either a stimulation trial or with their traditional system
- Is a good surgical candidate and qualified to receive the Neuspera SNM System per the device labeling
- Is capable of participating in all testing and follow-up clinic visits associated with this clinical study.
Who cannot join
- Has a contraindication for the Neuspera SNM System per the device labeling.
- Has plans to enroll or is currently enrolled in another investigational device or drug trial during his/her participation in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Specialty Clinical Research of St. Louis
St Louis, Missouri, 63141
Travis Bullock, MD, jking@helios-stl.com
Jacqueline King, jking@helios-stl.com
About this study
Official title: Follow-up Revision Experience and Evaluation of Device Outcomes Metrics in Subjects Receiving Replacement of Traditional Sacral Neuromodulation (SNM) With the Neuspera SNM System
Single-arm study where subjects' responses to a questionnaire for the traditional Sacral Neuromodulation (SNM) devices will be compared to the responses regarding the Neuspera SNM System.
Read the detailed description
Subjects will be enrolled in a single-arm study and followed for 1-month after implant of the Neuspera SNM System.
Subjects will complete a questionnaire regarding their experience with the traditional SNM system prior to the Neuspera implant, then undergo an implant of the Neuspera SNM system using standard of care according to the device's commercial labeling.
Up to 20 subjects will be enrolled.
- Conditions
- Urinary Urge Incontinence
- Being tested
- Neuspera Implantable Sacral Neuromodulation System
- Medical subject headings
- Urinary Incontinence, Urge
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 Replacement Cohort | Subjects with previous traditional SNM system and now undergoing implant of the Neuspera SNM 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.
Subject Questionnaire
The changes to subject questionnaire responses for the Neuspera SNM system compared to responses regarding traditional SNM systems.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Apr 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Urge 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuspera Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kellen Choi, DO, Principal investigator, University of Louisville Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383688
- Sponsor's protocol ID
- Neuspera Medical (NSM-007)
- Status last verified
- Oct 2026
- First submitted
- 26 Jan 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Revision Experience and Evaluation of Device Outcomes Metrics in Subjects Receiving Replacement of Traditional Sacral Neuromodulation (SNM) With the Neuspera SNM System
- ClinicalTrials.gov ID
- NCT07383688
- Acronym / sponsor ID
- Neuspera Medical (NSM-007)
- Conditions
- Urinary Urge Incontinence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Neuspera Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 3 Feb 2026 (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.
Single-arm study where subjects' responses to a questionnaire for the traditional Sacral Neuromodulation (SNM) devices will be compared to the responses regarding the Neuspera SNM System.
Detailed description
Subjects will be enrolled in a single-arm study and followed for 1-month after implant of the Neuspera SNM System.
Subjects will complete a questionnaire regarding their experience with the traditional SNM system prior to the Neuspera implant, then undergo an implant of the Neuspera SNM system using standard of care according to the device's commercial labeling.
Up to 20 subjects will be enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuspera Replacement Cohort | – | Device: Neuspera Implantable Sacral Neuromodulation SystemSubjects with previous traditional SNM system and now undergoing implant of the Neuspera SNM System |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population with 22 years of age or older and who have or have previously had a traditional SNM system.
Key inclusion criteria (5 listed)
- Currently have a traditional SNM device and has decided to have the device replaced with the Neuspera SNM System OR previously had an existing traditional SNM implant that was completely removed within the last year
- Is 22 years of age or older
- Had documented at least 50% improvement in UUI episodes on a bladder diary with either a stimulation trial or with their traditional system
- Is a good surgical candidate and qualified to receive the Neuspera SNM System per the device labeling
- Is capable of participating in all testing and follow-up clinic visits associated with this clinical study.
Key exclusion criteria (2 listed)
- Has a contraindication for the Neuspera SNM System per the device labeling.
- Has plans to enroll or is currently enrolled in another investigational device or drug trial during his/her participation in this study
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 Replacement Cohort |
Primary outcome
Subject Questionnaire
Time frame: 1 month
The changes to subject questionnaire responses for the Neuspera SNM system compared to responses regarding traditional SNM systems.
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 14 Oct 2026.
- Neuspera Medical web pageLink provided by the sponsor.
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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.
Kellen Choi, DO principal investigator
University of Louisville Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Urge Incontinence, run by Neuspera Medical, Inc. at 1 site 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 5 inclusion and 2 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 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Subject Questionnaire (time frame: 1 month). 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 14 Oct 2026.