Percutaneous Nerve Evaluation Trial Time

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Chicago

About this trial

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 that shortening PNE trial time to 3 days from 7 days will not result in a lower proportion of PNE trials leading to SNM implantation and may offer less time for lead migration. The investigators aim to perform a multi-center, randomized trial to determine if a 3-day PNE trial is not inferior to a 7-day PNE trial with respect to rates of progression to SNM implantation.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Sacral neuromodulation

Treatment groups

193 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Chicago

Lead sponsor

Allegheny Health Network

Collaborator

University of California, Irvine

Collaborator

Atrium Health Wake Forest Baptist

Collaborator

University of Texas

Collaborator

Brown University

Collaborator