Study of Medtronic InterStim Lead Implant for Overactive Bladder, Fecal Incontinence, and Urinary Retention with Physiological Signal Monitoring

What this Trial Is About

Researchers are evaluating the collection of physiological signals at multiple timepoints during the therapy evaluation period in individuals with overactive bladder, fecal incontinence, or urinary retention. This interventional study involves patients who are candidates for or undergoing Medtronic InterStim lead implant therapy for these conditions. The purpose is to monitor and record physiological responses related to sacral neuromodulation treatment, a device that delivers electrical stimulation to a sacral nerve. The study focuses on the use of sacral neuromodulation as the investigational device. Participants will undergo therapy evaluation involving the Medtronic InterStim lead implant, during which physiological signals will be collected from one day up to seven months. This evaluation period is designed to observe the effects and gather data while participants maintain their current medication regimens for their conditions. The study does not involve masking or blinding and includes only one study arm centered on this device-based therapy. Participants will provide informed consent and complete diaries, questionnaires, and study visits as part of the protocol. Researchers will collect physiological signals at several timepoints during the evaluation period and monitor adherence to medication and study procedures. The primary outcome is the number of subjects with physiological signals collected at each timepoint from one day to seven months. The total study duration and follow-up align with this time frame. Safety assessments and compliance monitoring are integral parts of the participant involvement.

Pelvic Health Electrically Evoked Recording (PEER) 2 Study