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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Sacral neuromodulation
Procedure/SurgerySacral neuromodulation (SNM) is a minimally invasive procedure that provides low-amplitude electrical stimulation to the S3 nerve root to improve micturition and defecation. Patients who elect to proceed with SNM undergo a trial phase to determine therapeutic response prior to placement of a permanent implantable pulse generator (IPG). A trial phase can be performed in two ways: a percutaneous nerve evaluation (PNE) or staged implantation. PNE involves the placement of a temporary wire connected to an electrode using external stimulation. It is performed in the office using local anesthesia. If the patient displays adequate improvement in symptoms (defined as \>50% improvement of symptoms from baseline), a permanent lead and subcutaneous IPG are implanted in the operating room.
Treatment groups
193 Participants
are divided into 2 treatment groupsGroup A: 3-day trialExperimental treatment 1 intervention
Group B: 7-day trialActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rate of progression onto full sacral neuomodulation (SNM) implant
Participants with an adequate therapeutic response during percutaneous nerve evaluation (PNE) trial (\>/=50% improvement in urgency urinary incontinence (UUI)/ urgency-frequency (UF) symptoms) will progress onto full SNM implantation
Time frame
3 or 7 days depending on treatment armSecondary outcomes
1
Patient satisfaction
Participants will complete validated patient reported outcome measures at baseline and at PNE lead pull
Time frame
3 or 7 days depending on treatment arm2
Rate of adverse events
Adverse events during trial phase will be recorded
Time frame
3 or 7 days depending on treatment arm3
Quality of life scores
Participants will complete validated patient reported outcome measures at baseline and at PNE lead pull
Time frame
3 or 7 days depending on treatment armSponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov