Feasibility of Parasacral Transcutaneous Electrical Nerve Stimulation PTENS for Voiding Dysfunction in Peds Population

Study Overview
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Brief Summary
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Pilot study for determining feasibility of home parasacral transcutaneous electrical nerve stimulation in treatment of urinary urgency and incontinence.

Detailed Description
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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.

Official Title
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Feasibility of Home Parasacral Transcutaneous Electrical Nerve Stimulation (PTENS) for the Voiding Dysfunction in the Pediatric Population: A Pilot Study

Conditions
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Overactive Bladder, Voiding Disorders, Incontinence, Urinary

Intervention / Treatment
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* Device: parasacral transcutaneous electrical nerve stimulation (PTENS)
* Other: Standard Urotherapy


Participation Criteria
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Eligibility Criteria
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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 Known anatomic lower urinary tract abnormality (may be congenital or iatrogenic) Bowel only voiding dysfunction (Constipation ICD-10 K59.00) Non-English speaking families Families with health literacy precluding completion of questionnaires and voiding diaries Concurrent use of anticholinergics, alpha blockers or beta agonists for urologic treatments Untreated urinary tract infection

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Urotherapy<br>Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management. | Other: Standard Urotherapy<br>* standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.<br>|
| Experimental: Standard Urotherapy + PTENS<br>Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management AND use parasacral percutaneous TENS as additional treatment. | Device: parasacral transcutaneous electrical nerve stimulation (PTENS)<br>* electrode patches placed on skin of lower back just above each side of the gluteal cleft (parasacral) and attached to TENS unit at specific settings three times a week for 30 minutes for 12 weeks.<br>Other: Standard Urotherapy<br>* standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dysfunctional Voiding Symptom Score | 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). | week 6 | 
| Voiding Diary and the Number of Episodes of Incontinence Per Day | 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. | week 6, week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Outcome. Review of Adverse Events. | Confirmation of safety and identification of potential adverse events. We will review all data for potential adverse events. | Week 6 through Week 12 |