Percutaneous Nerve Evaluation Trial Time

Summary

Sacral neuromodulation (SNM) was approved by the Food and Drug Administration (FDA) for the treatment of urgency incontinence (UUI) in 1998. One of two trial phase techniques are utilized prior to placement of the implantable pulse generator (IPG) to predict a patient's success with the device: a percutaneous nerve evaluation (PNE) or a stage implantation. Patients who experience a \> 50% improvement in UUI symptoms progress to permanent implantation. PNE offers significant advantages compared to a staged implantation including a single anesthetic and operating room trip. Historically, full implantation rates are only 40-50% following PNE versus 70-90% in women who undergo a staged approach. The lower rate of progression to full implantation after PNE may be attributed to lead migration. Newer data suggest up to 90% of PNE trials lead to full implantation. The investigators hypothesize that shortening PNE trial time to 3 days from 7 days will not result in a lower proportion of PNE trials leading to SNM implantation and may offer less time for lead migration. The investigators aim to perform a multi-center, randomized trial to determine if a 3-day PNE trial is not inferior to a 7-day PNE trial with respect to rates of progression to SNM implantation.

Conditions

• Urge Incontinence
• Urgency-frequency Syndrome
• Overactive 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.

Sponsors & Collaborators

• Allegheny Health Network

  collaborator OTHER

• University of California, Irvine

  collaborator OTHER

• Atrium Health Wake Forest Baptist

  collaborator OTHER

• University of Texas

  collaborator OTHER

• Brown University

  collaborator OTHER

• University of Chicago

  lead OTHER

Principal Investigators

• Kimberly Kenton, MD · University of Chicago

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-12-10

Primary Completion

2026-12-31

Completion

2026-12-31

FDA Device

Yes

Countries

• United States

Study Locations