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

NCT04570605 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-03-17

Study results available
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Summary

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

Conditions

Interventions

DEVICE

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.

OTHER

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.

Sponsors & Collaborators

Principal Investigators

  • Glen A Lau, MD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2020-06-01
Completion
2020-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04570605 on ClinicalTrials.gov