Shortening the trial time for sacral neuromodulation in treating urinary incontinence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.