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Percutaneous Nerve Evaluation Trial Time

RecruitingNAAges 18 Years - anyFemaleUniversity of Chicago
NCT06226220 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 t

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📋 Eligibility rules (as published)
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
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What it tests

  • Sacral neuromodulation
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Where

1 site
University of Chicago
Chicago, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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