CPT Testing for Sacral Neuromodulation Outcomes
This is a prospective study. Subjects will be recruited from the urology practices of Dr. Ken Peters and Dr. Ananias Diokno at William Beaumont Hospital. Subjects will be referred to the study by the clinician recommending Sacral NeuroModulation therapy (SNM).
This pilot study is to explore the effect of SNM on sensory pathways by measuring CPT values pre and post SNM treatment.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Current Perception Threshold Testing for Sacral Neuuromodulation Outcomes|
- The primary endpoint is the change in CPT measurement after placement of SNM therapy as compared to baseline CPT measurements. [ Time Frame: visit 1 ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Procedure: Current Perception Threshold (CPT) Testing
Patients will be scheduled 1-2 weeks prior to planned implantation of the SNM wire electrode (Stage 1). Patients that do not have a 50% improvement in their symptoms in Stage 1 will not go on to Stage II procedures and will not undergo further CPT testing.
After enrollment, the subjects will complete a short medical history questionnaire confirming that they meet inclusion criteria and do not fall under exclusion criteria. This will include review of recent urinalysis and/or urine culture confirming the absence of a recent urinary tract infection. Participants will be given information on the relevant CPT testing including the need for bladder/urethra catheterization as part of that testing pre and post SNM therapy.
At the baseline testing visit, subjects will undergo CPT testing using transcutaneous stimulation in the distribution of the pudendal nerve on the perineum. Subjects will undergo bladder/urethral catheterization in using standard sterile technique. Once the bladder/urethral catheter is in place CPT testing will be conducted at various frequencies of to identify the current perception thresholds of each nerve fiber.
At the conclusion of the testing the catheter will be removed and the subjects will be given a single dose of an oral antibiotic to minimize infection. This meeting and testing will require approximately 60 minutes.
Patients will undergo Stage I of the SNM procedure with their own physician at a subsequent appointment.
If subjects have a 50% improvement in their symptoms after 2 weeks with Stage 1 SNM, they will under go Stage II of the SNM procedure.
The subjects will have an appointment scheduled for their follow-up CPT testing at the clinical research office 4 to 6 weeks after the Stage II procedure. The subject will be given a urinalysis and urine culture lab slip, and will be instructed to drop a urine sample off at the lab 3 days before their scheduled appointment for testing. If their urine culture is positive, they will be given a prescription for an antibiotic and excluded from this testing. They may however be tested once their urine culture is negative, as long as it is within 2 weeks of their original post-stage 2 CPT test appointment
Subjects will undergo repeat CPT testing using transcutaneous stimulation in the distribution of the pudendal nerve on the perineum. Subjects will then undergo bladder/urethral catheterization using standard sterile technique. Once the bladder/urethral catheter is in place CPT testing will then be conducted at various frequencies to identify the current perception thresholds of each nerve fiber.
At the conclusion of the testing the catheter will be removed and the patients will be given a single dose of an oral antibiotic to minimize infection. This evaluation will require approximately 60 minutes.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00617786
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||Kenneth Peters, M.D.||William Beaumont Hospitals|