NCT06226220 Percutaneous Nerve Evaluation Trial Time
| NCT ID | NCT06226220 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Chicago |
| Condition | Urge Incontinence |
| Study Type | INTERVENTIONAL |
| Enrollment | 193 participants |
| Start Date | 2023-12-10 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 193 participants in total. It began in 2023-12-10 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Kimberly Kenton, MD
PRINCIPAL INVESTIGATOR
University of Chicago
Frequently Asked Questions
Who can join the NCT06226220 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Urge Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06226220 currently recruiting?
Yes, NCT06226220 is actively recruiting participants. Contact the research team at sashmore@uchicagomedicine.org for enrollment information.
Where is the NCT06226220 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06226220 clinical trial?
NCT06226220 is sponsored by University of Chicago. The principal investigator is Kimberly Kenton, MD at University of Chicago. The trial plans to enroll 193 participants.