Shortening the trial time for sacral neuromodulation in treating urinary incontinence
Trial Time for Percutaneous Nerve Evaluation in Patients Undergoing Sacral Neuromodulation for Urgency Urinary Incontinence or Urgency-frequency: a Randomized Control Trial
This study is testing if cutting the trial period for a nerve treatment from 7 days to 3 days can still help women with urinary incontinence feel better before getting a permanent device.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 193 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06226220 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of reducing the percutaneous nerve evaluation (PNE) trial time from 7 days to 3 days for patients undergoing sacral neuromodulation (SNM) for urgency urinary incontinence (UUI). The study aims to determine if this shortened trial period can still yield a successful response, defined as a greater than 50% improvement in symptoms, leading to permanent implantation of the device. The trial will involve non-pregnant women aged 18 and older who meet specific criteria related to their urinary incontinence episodes. The goal is to enhance patient experience by minimizing the time required for the trial phase while maintaining efficacy.
Who should consider this trial
Good fit: Ideal candidates are non-pregnant women aged 18 and older with urgency urinary incontinence who are willing to undergo the PNE testing phase.
Not a fit: Patients with non-obstructive urinary retention, severe diabetes, neurological diseases, or prior pelvic irradiation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to quicker treatment initiation for patients suffering from urgency urinary incontinence.
How similar studies have performed: Previous studies have shown varying success rates with sacral neuromodulation approaches, but this specific reduction in trial time is a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois
- University of Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Kimberly Kenton, MD — University of Chicago
- Study coordinator: Sarah L Ashmore, MD
- Email: sashmore@uchicagomedicine.org
- Phone: 9705811554
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.