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Percutaneous Nerve Evaluation Trial Time

University of Chicago · with Allegheny Health Network, University of California, Irvine · NCT06226220

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · Women only
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
193
US sites recruiting
1
Study start
December 10, 2023
Record last updated
February 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Sacral neuromodulation

Conditions: Urge Incontinence; Urgency-frequency Syndrome; Overactive Bladder

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Non-pregnant women >/=18 years old undergoing sacral neuromodulation (SNM) treatment for urgency urinary incontinence (UUI) or urgency-frequency (UF) who have elected to undergo testing phase with a PNE
  • >/=5 UUI episodes on a 3-day bladder diary with urge incontinence representing >/=50% of total incontinence episodes recorded or >/=8 per day for 2 days on a 3-day bladder diary
  • Willing and able to complete all study related items and interviews
  • Grossly neurologically normal exam

Exclusion Criteria

  • SNM indication of non-obstructive urinary retention or isolated fecal incontinence
  • Severe or poorly controlled diabetes (defined as HgbA1c >/=8.0) or diabetes with peripheral nerve involvement
  • Neurological diseases such as multiple sclerosis, clinically significant peripheral neuropathy, or complete spinal cord injury
  • Surgically altered detrusor muscle (i.e. Augmentation cystoplasty)
  • Current or prior bladder malignancy
  • Prior pelvic irradiation
  • Post void residual (PVR) >/= 150 mL within 6 months prior to enrollment
  • Active urinary tract infection
  • Primary stress urinary incontinence or mixed urinary incontinence with stress predominance
  • >/= Stage III pelvic organ or vaginal vault prolapse and/or current pessary use

Recruiting US locations

  • University of Chicago

    Chicago, IL 60637

    Site contact: Sarah Ashmore, MD · 970-581-1554 · sashmore@uchicagomedicine.org

Study contacts (from the official record)

  • Sarah L Ashmore, MD · 9705811554 · sashmore@uchicagomedicine.org
  • Rowena Shi · jinxuanshi@uchicago.edu
All women’s health studies in Illinois →
Percutaneous Nerve Evaluation Trial Time (NCT06226220) | Bored Studies