Neuspera Replacement Survey Study

Neuspera Medical

Status

Not yet enrolling

Conditions

Urinary Urge Incontinence

Treatments

Device: Neuspera Implantable Sacral Neuromodulation System

Study type

Observational

Funder types

Industry

Identifiers

NCT07383688

Neuspera Medical (NSM-007)

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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