Percutaneous Nerve Evaluation Trial Time

NARecruitingINTERVENTIONAL
Enrollment

193

Participants

Timeline

Start Date

December 10, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Urge IncontinenceUrgency-frequency SyndromeOveractive Bladder
Interventions
PROCEDURE

Sacral neuromodulation

Sacral neuromodulation (SNM) is a minimally invasive procedure that provides low-amplitude electrical stimulation to the S3 nerve root to improve micturition and defecation. Patients who elect to proceed with SNM undergo a trial phase to determine therapeutic response prior to placement of a permanent implantable pulse generator (IPG). A trial phase can be performed in two ways: a percutaneous nerve evaluation (PNE) or staged implantation. PNE involves the placement of a temporary wire connected to an electrode using external stimulation. It is performed in the office using local anesthesia. If the patient displays adequate improvement in symptoms (defined as \>50% improvement of symptoms from baseline), a permanent lead and subcutaneous IPG are implanted in the operating room.

Trial Locations (1)

60637

RECRUITING

University of Chicago, Chicago

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Allegheny Health Network

OTHER

collaborator

University of California, Irvine

OTHER

collaborator

Atrium Health Wake Forest Baptist

OTHER

collaborator

University of Texas

OTHER

collaborator

Brown University

OTHER

lead

University of Chicago

OTHER

NCT06226220 - Percutaneous Nerve Evaluation Trial Time | Biotech Hunter | Biotech Hunter