Neuspera Revision Registry - Follow up Revision Experience and Evaluation of Device Outcomes Metrics

Conditions: Urinary Urge Incontinence

Sex: All

Ages: 22 Years – N/A

Healthy volunteers: No

Enrollment: 100

Sponsor: Neuspera Medical, Inc.

Location: Specialty Clinical Research of St. Louis St Louis Missouri

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.

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07383688). StuddyBuddy aggregates publicly available trial information.