Recruiting

Sacral Neuromodulation

Sponsor:

Neuspera Medical, Inc.

Code:

NCT07383688

Conditions

Urinary Urge Incontinence

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Neuspera Implantable Sacral Neuromodulation System

Study Details

Brief 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.

Conditions

Urinary Urge Incontinence

Study ID

NCT07383688

Start date

Apr 1, 2026

Status verified date

Oct, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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
2. Is 22 years of age or older
3. Had documented at least 50% improvement in UUI episodes on a bladder diary with either a stimulation trial or with their traditional system
4. Is a good surgical candidate and qualified to receive the Neuspera SNM System per the device labeling
5. Is capable of participating in all testing and follow-up clinic visits associated with this clinical study.

Exclusion Criteria:

1. Has a contraindication for the Neuspera SNM System per the device labeling.
2. Has plans to enroll or is currently enrolled in another investigational device or drug trial during his/her participation in this study

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Neuspera Replacement Cohort

Subjects with previous traditional SNM system and now undergoing implant of the Neuspera SNM System

Interventions

Neuspera Implantable Sacral Neuromodulation System

Stimulation of the Sacral Nerve

Primary outcome measure

  • Subject Questionnaire [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Mark Vollmer

408-433-3839mark.vollmer@neuspera.com

Shital Patel

3235281320shital.patel@neuspera.com

Locations

Specialty Clinical Research of St. Louis

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Travis Bullock, MD

jking@helios-stl.com

Jacqueline King

jking@helios-stl.com

More Information

Sponsor

Neuspera Medical, Inc.

Last update posted

Oct 14, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-15. This information was provided to ClinicalTrials.gov by Neuspera Medical, Inc. on 2026-10-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.