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

NCT ID: NCT04570605

Last Updated: 2022-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2020-07-01

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.

Conditions

Overactive Bladder; Voiding Disorders; Incontinence, Urinary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard Urotherapy

Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management.

Group Type: ACTIVE_COMPARATOR

Standard Urotherapy

Intervention Type: OTHER

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.

Standard Urotherapy + PTENS

Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management AND use parasacral percutaneous TENS as additional treatment.

Group Type: EXPERIMENTAL

parasacral transcutaneous electrical nerve stimulation (PTENS)

Intervention Type: DEVICE

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.

Standard Urotherapy

Intervention Type: OTHER

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.

Interventions

parasacral transcutaneous electrical nerve stimulation (PTENS)

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.

Intervention Type: DEVICE

Standard Urotherapy

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Glen Lau

Assistant Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Glen A Lau, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah/Primary Children's Pediatric Urology

Salt Lake City, Utah, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 28089606 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10958730 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

117756

Identifier Type: -

Identifier Source: org_study_id