Search / Trial NCT06226220

Percutaneous Nerve Evaluation Trial Time

Launched by UNIVERSITY OF CHICAGO · Jan 16, 2024

Trial Information

Current as of October 07, 2024

Recruiting

Keywords

Urinary Urgency Urinary Incontinence Urinary Frequency Overactive Bladder Sacral Neuromodulation Percutaneous Nerve Evaluation

Description

Sacral neuromodulation (SNM) is a minimally invasive procedure that provides low-amplitude electrical stimulation to the S3 nerve root to improve micturition and defecation. It is FDA-approved for the treatment of urgency urinary incontinence (UUI) refractory to behavioral modifications and/or oral medication. The efficacy of SNM for the treatment of UUI is well studied and currently, there are two manufacturers of SNM devices within the United States: Medtronic and Axonics. Both offer rechargeable and non-rechargeable devices. Patients who elect to proceed with SNM undergo a trial phase t...

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

About University Of Chicago

The University of Chicago is a prestigious research institution renowned for its commitment to advancing medical science through innovative clinical trials. With a robust infrastructure that supports multidisciplinary collaboration, the University actively engages in cutting-edge research across various therapeutic areas. Its dedicated team of experienced investigators and state-of-the-art facilities enable the University of Chicago to conduct rigorous clinical studies aimed at improving patient outcomes and translating scientific discoveries into tangible healthcare solutions. The institution prioritizes ethical standards and patient safety, ensuring that all trials adhere to the highest regulatory guidelines and best practices in clinical research.

Locations

Chicago, Illinois, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0