Clinical trial NCT00617786: CPT Testing for Sacral Neuromodulation Outcomes
Official title: Current Perception Threshold Testing for Sacral Neuuromodulation Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incontinence
Keywords: urinary urgency
urinary frequency
urge incontinence
sacral neuromodulation therapy
urgency
frequency
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2008-02-18
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Established diagnosed overactive bladder
* Scheduled to receive SMN therapy by Dr. Peters or Dr. Diokno
* Women at least 18 years of age
* Capable of giving informed consent
* Capable and willing to follow all study related procedures (e.g. bladder and urethral catheterization, answering questions during CPT testing, complete questionnaires regarding pertinent medical history).

Exclusion Criteria:

* Current Urinary tract infection
* Currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function.
* Pregnancy or intending to become pregnant during the study
* Cannot independently comprehend and complete relevant medical history questionnaires.
* The subject is deemed unsuitable for enrollment in this study by the investigators based on their history.
* Men are excluded
* TENS, PTNS or acupuncture therapy currently being used for symptoms

Primary outcomes:
measure: The primary endpoint is the change in CPT measurement after placement of SNM therapy as compared to baseline CPT measurements.
timeFrame: visit 1
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Kenneth Peters, M.D.
role: PRINCIPAL_INVESTIGATOR
References: