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
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