Actively Recruiting
Percutaneous Nerve Evaluation Trial Time
Led by University of Chicago · Updated on 2026-02-09
193
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
Sponsors
U
University of Chicago
Lead Sponsor
A
Allegheny Health Network
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Percutaneous Nerve Evaluation Trial Time
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Non-pregnant women aged 18 years or older undergoing sacral neuromodulation for urgency urinary incontinence or urgency-frequency who have chosen to undergo a PNE trial
- At least 5 urgency urinary incontinence episodes on a 3-day bladder diary with urge incontinence making up 50% or more of total incontinence episodes, or at least 8 voids per day for 2 days on a 3-day bladder diary
- Willing and able to complete all study-related tasks and interviews
- Grossly normal neurological examination
You will not qualify if you...
- Sacral neuromodulation indicated for non-obstructive urinary retention or isolated fecal incontinence
- Severe or poorly controlled diabetes (HgbA1c 8.0 or higher) or diabetes with peripheral nerve involvement
- Neurological diseases such as multiple sclerosis, significant peripheral neuropathy, or complete spinal cord injury
- Surgically altered detrusor muscle such as augmentation cystoplasty
- Current or prior bladder cancer
- Prior pelvic radiation therapy
- Post-void residual urine volume of 150 mL or more within 6 months before enrollment
- Active urinary tract infection
- Primary stress urinary incontinence or mixed urinary incontinence with stress predominance
- Stage III or higher pelvic organ or vaginal vault prolapse or current use of a pessary
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
S
Sarah L Ashmore, MD
CONTACT
R
Rowena Shi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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