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
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