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

NCT04570605 | Completed Results FDA Device

• 1 other identifier: 117756
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Overactive Bladder; Voiding Disorders; Incontinence, Urinary

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Secondary Outcome. Review of Adverse Events.

  Week 6 through Week 12

Study Arms (2)

Standard Urotherapy

ACTIVE COMPARATOR

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

Other: Standard Urotherapy

Standard Urotherapy + PTENS

EXPERIMENTAL

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); Other: Standard Urotherapy

Interventions

parasacral transcutaneous electrical nerve stimulation (PTENS) 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 + PTENS

Standard Urotherapy 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; Standard Urotherapy + PTENS

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah/Primary Children's Pediatric Urology

Salt Lake City, Utah, 84112, United States

Location

Related Publications (2)

• 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.

  PMID: 28089606 BACKGROUND

• 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.

  PMID: 10958730 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders

Limitations and Caveats

Limitations included patients being lost to follow-up or not completing their voiding diaries or DVSS questionnaires so that the number of patients with complete information was only slightly higher than half of the total who were initially enrolled.

Results Point of Contact

• Title: Glen Lau, MD
• Organization: University of Utah School of Medicine

Glen.Lau@hsc.utah.edu

801-213-2700

Study Officials

• Glen A Lau, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: patients will be randomized to standard urotherapy or urotherapy + PTENS
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: April 19, 2019
• First Posted: September 30, 2020
• Study Start: April 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2020
• Last Updated: March 17, 2022
• Results First Posted: March 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)