Clinical trial NCT04570605: Feasibility of Parasacral Transcutaneous Electrical Nerve Stimulation PTENS for Voiding Dysfunction in Peds Population
Official title: Feasibility of Home Parasacral Transcutaneous Electrical Nerve Stimulation (PTENS) for the Voiding Dysfunction in the Pediatric Population: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Voiding Disorders
Incontinence, Urinary
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Dysfunctional Voiding Symptom Score
timeFrame: week 6
measure: Voiding Diary and the Number of Episodes of Incontinence Per Day
timeFrame: week 6, week 12
Secondary outcomes:
measure: Secondary Outcome. Review of Adverse Events.
timeFrame: Week 6 through Week 12
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah/Primary Children's Pediatric Urology
state: Utah
Study officials:
affiliation: University of Utah
name: Glen A Lau, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Paula LIDS, de Oliveira LF, Cruz BP, de Oliveira DM, Miranda LM, de Moraes Ribeiro M, Duque RO, de Figueiredo AA, de Bessa J Jr, Netto JMB. Parasacral transcutaneous electrical neural stimulation (PTENS) once a week for the treatment of overactive bladder in children: A randomized controlled trial. J Pediatr Urol. 2017 Jun;13(3):263.e1-263.e6. doi: 10.1016/j.jpurol.2016.11.019. Epub 2016 Dec 21.
citation: Farhat W, Bagli DJ, Capolicchio G, O'Reilly S, Merguerian PA, Khoury A, McLorie GA. The dysfunctional voiding scoring system: quantitative standardization of dysfunctional voiding symptoms in children. J Urol. 2000 Sep;164(3 Pt 2):1011-5. doi: 10.1097/00005392-200009020-00023.