Parasacral TENS Project

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
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.
Epistemonikos ID: 2075626c5f7b3ce04323772d0d07ca100bb6e608
First added on: Oct 24, 2026