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NOT YET RECRUITING
NCT07892417
NA

Parasacral TENS Project

Sponsor: University of Virginia

View on ClinicalTrials.gov

Summary

The purpose of the project is to compare the efficacy of parasacral transcutaneous electric nerve stimulation (TENS) versus standard second-line therapy (oral anticholinergics) for pediatric patients with overactive bladder (OAB) and lower urinary tract dysfunction who have previously failed standard urotherapy. The investigators aim to evaluate the changes in lower urinary tract symptoms, quality of life scores, adherence to treatment, and parental/patient satisfaction with both treatment models. Pediatric patients aged 6 years and older who are seen in the clinic for overactive bladder and have failed to improve their lower urinary tract symptoms with standard urotherapy alone will be randomized to receive either parasacral TENS or oxybutynin, an oral anticholinergic medication routinely used in pediatric patients for this condition. Patients randomized to parasacral TENS will receive a treatment plan that includes initial instructions on how to apply and use the TENS unit. The patients will perform 30-minute sessions, twice a week, for 12 weeks. A TENS unit will be loaned to the family for the duration of the treatment. This therapy will be administered at home by their guardians. Bladder diaries, the Vancouver Scoring System for Dysfunctional Elimination, and Likert scales for parental and patient preference and adherence to treatment will be administered prior to starting the study, at week 4, week 8, and upon completion of treatment to analyze the efficacy of TENS in treating pediatric overactive bladder compared to oxybutynin.

Official title: Parasacral Transcutaneous Electrical Nerve Stimulation vs. Standard Second-Line Therapy for Overactive Bladder in Pediatric Patients

Key Details

Gender

All

Age Range

4 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-09-30

Completion Date

2029-09-28

Last Updated

2026-10-23

Healthy Volunteers

No

Interventions

OTHER

Parasacral transcutaneous electric nerve stimulation (TENS)

Electrical stimulation can be delivered in multiple ways: transcutaneously (using EMG patches or needle electrodes) or via the implantation of a stimulator. Stimulation is applied at the parasacral plexus or via the posterior tibial nerve to the sacral plexus. In children, transcutaneous EMG patches that deliver a current to the parasacral space have been used to treat bladder overactivity and are preferable due to the associated ability to provide care at home and with less discomfort than needle electrode insertion.

DRUG

Oxybutynin

Standard second-line therapy (oral anticholinergics)