Recruiting

Observational Study

Sponsor:

University of Chicago

Code:

NCT06226220

Conditions

Urge Incontinence

Urgency-frequency Syndrome

Overactive Bladder

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Sacral neuromodulation

Study Details

Brief 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

Study ID

NCT06226220

Start date

Dec 10, 2023

Status verified date

Feb, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

193 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 3-day trial

Patients randomized to the 3-day trial arm will undergo a 3-day PNE trial phase for sacral neuromodulation. Participants will have the PNE placed in the office and return on day 3 for PNE removal.

active comparator: 7-day trial

Patients randomized to the73-day trial arm will undergo a 7-day PNE trial time for sacral neuromodulation. Participants will have the PNE placed in the office and return on day 7 for PNE removal.

Interventions

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.

Primary outcome measure

  • Rate of progression onto full sacral neuomodulation (SNM) implant [ Time Frame: 3 or 7 days depending on treatment arm ]

Central Contacts and Locations

Central contacts

Sarah L Ashmore, MD

9705811554sashmore@uchicagomedicine.org

Rowena Shi

jinxuanshi@uchicago.edu

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Sarah Ashmore, MD

970-581-1554sashmore@uchicagomedicine.org

Rowena Shi

jinxuanshi@uchicago.edu

Principal Investigator:

Kimberly Kenton, MD

More Information

Sponsor

University of Chicago

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Keywords

  • urinary urgency
  • urinary incontinence
  • urinary frequency
  • overactive bladder
  • sacral neuromodulation
  • percutaneous nerve evaluation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-02-09.