Feasibility of Home Parasacral Transcutaneous Electrical Nerve Stimulation (PTENS) for the Voiding Dysfunction in the Pediatric Population: A Pilot Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Overactive Bladder
- Sponsor
- University of Utah
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Dysfunctional Voiding Symptom Score
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
Pilot study for determining feasibility of home parasacral transcutaneous electrical nerve stimulation in treatment of urinary urgency and incontinence.
Detailed Description
Overactive bladder (OAB) is the most common voiding dysfunction in children1. While many children may outgrow these issues, for some these symptoms persists and can lead to emotional, social, behavioral and physical problems. Multiple treatments exist for OAB but rarely is there guaranteed success. Many behavioral and lifestyle treatments involve a significant time investment and office visits on the part of the patient and family. Furthermore, medication therapy is often associated with bothersome side effects and is discontinued, even despite efficacy2. As such, treatments with potentially less adverse effects, often used in adult urology, are making their way into the pediatric urology practice. These include intravesical botulinum toxin injections, sacral nerve stimulation (SNS) and percutaneous tibial nerve stimulation (PTNS). PTNS, first cleared by the United States Food and Drug Administration (FDA) in 2011 for adult use, has evolved into transcutaneous nerve stimulation in the pediatric population; obviating the need for needles during treatment. Studies suggest mixed efficacy in electric nerve stimulation for overactive bladder in the pediatric population, owing largely to the marked heterogeneity in treatment protocols. While some researchers follow the traditional tibial nerve pathway, others take a cue from SNS and target the parasacral area, while still others rely on signaling from even further peripheral nerves to modulate bladder overactivity 3-5. Perhaps further contributing to the disparate data is the varying treatment schedules used. Some centers perform treatments daily, others weekly, others twice or thrice a week. Similarly, some physicians recommend twenty-minute treatments, while others thirty or even sixty minutes. The majority of studies rely on an office-based treatment model, while a few have explored in home treatments 3-5. In the United States, there has been no study examining the feasibility or efficacy of home parasacral transcutaneous electric nerve stimulation (PTENS) on pediatric voiding dysfunction.
Investigators
Glen Lau
Assistant Professor of Surgery
University of Utah
Eligibility Criteria
Inclusion Criteria
- •Toilet trained (age 6) to age 17
- •Diagnosis of urinary dysfunction, voiding dysfunction, overactive bladder, urgency incontinence, nocturnal enuresis. (These patients may also have an element of bowel dysfunction; however, we will not include a patient who had ONLY bowel dysfunction and NOT a voiding dysfunction).
Exclusion Criteria
- •Known neurologic diagnosis - such as myelomeningocele, caudal regression
- •Known seizure disorder
- •Age \< 6 or \> 17
- •Lack of follow-up within 6 months of treatment
- •Pacemaker, vagal nerve stimulator, or other implanted electrical device
- •Intolerance of electrical nerve stimulation
- •Pregnancy
- •Implanted metal hardware
- •Open sores or wounds over the sacral area
- •Currently catheterizing for bladder drainage
Outcomes
Primary Outcomes
Dysfunctional Voiding Symptom Score
Time Frame: week 6
At week 6 a Dysfunctional Voiding Scoring System Score. Descriptive statistics will be used to analyze these data in comparison to pre-study scores. As stated above, Dysfunctional Voiding Symptom Score is a validated clinical questionnaire designed to quantify the severity of pediatric voiding dysfunction on a scale of 0 (non-existent) to 30 (most severe).
Voiding Diary and the Number of Episodes of Incontinence Per Day
Time Frame: week 6, week 12
48-hour Voiding Diary and Nighttime Wetting log will be repeated and evaluated. This was added as a separate primary outcome as it is separate from the Dysfunctional Voiding Symptom Score. The voiding diary will be used to evaluate the number of episodes of incontinence per day and descriptive statistics will be used to compare this to pre-study numbers.
Secondary Outcomes
- Secondary Outcome. Review of Adverse Events.(Week 6 through Week 12)