Percutaneous Nerve Evaluation Trial for Overactive Bladder

This study is looking at a procedure called sacral neuromodulation (SNM) for women who have urge incontinence (leaking urine when you feel a sudden urge), urgency-frequency syndrome (frequent and sudden urges to urinate), or overactive bladder. SNM uses a small electrical stimulation to a nerve to help improve bladder control. Before getting a permanent SNM device, patients undergo a trial phase. This study is specifically looking at how many women who try a percutaneous nerve evaluation (PNE) — a temporary test with a wire and external stimulation — go on to get the full SNM implant. You may be able to join if you are a non-pregnant woman at least 18 years old with significant urge incontinence or urgency-frequency, and are already considering SNM treatment with a PNE.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 193 women.
What's involved
You would undergo a percutaneous nerve evaluation (PNE) as part of the sacral neuromodulation (SNM) treatment process.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study is measured at 3 or 7 days, depending on the treatment arm.

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NCT06226220

Percutaneous Nerve Evaluation Trial Time

Recruiting
NAAges 18+InterventionalTreatment
University of Chicago
~193 participants
Updated 2026-02-09 on ClinicalTrials.gov
What's tested:Sacral neuromodulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of progression onto full sacral neuomodulation (SNM) implant
Measured over 3 or 7 days depending on treatment arm
Urge Incontinence
Urgency-frequency Syndrome
Overactive Bladder
1 sites across 1 states
Illinois1
  • Kimberly Kenton, MD · PRINCIPAL_INVESTIGATOR · University of Chicago

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Eligibility criteria

Inclusion

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

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
  • Rate of progression onto full sacral neuomodulation (SNM) implant3 or 7 days depending on treatment arm

    Participants with an adequate therapeutic response during percutaneous nerve evaluation (PNE) trial (\>/=50% improvement in urgency urinary incontinence (UUI)/ urgency-frequency (UF) symptoms) will progress onto full SNM implantation