Percutaneous Nerve Evaluation Trial Time

Launched by UNIVERSITY OF CHICAGO · Jan 16, 2024

Keywords

ClinConnect Summary

The Percutaneous Nerve Evaluation Trial is studying a treatment called sacral neuromodulation (SNM) for women suffering from conditions like urge incontinence and overactive bladder. This trial is exploring whether reducing the testing time for a specific procedure called percutaneous nerve evaluation (PNE) from 7 days to just 3 days can still effectively predict if patients will benefit from the SNM device. The goal is to find out if a shorter trial period will lead to similar success rates for full implantation of the device, while also minimizing complications like lead movement.

To participate in this trial, women aged 18 and older who are experiencing significant urge incontinence may be eligible, especially if they have been keeping track of their bladder habits. Participants will undergo a trial period to see how well the treatment works before deciding on permanent implantation. The study is currently recruiting participants, and by taking part, women can contribute to important research that may improve treatment options for others with similar conditions.

Gender

FEMALE

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