An interventional study of Parasacral transcutaneous electric nerve stimulation (TENS) and Oxybutynin in Overactive Bladder (OAB) and Lower Urinary Tract Dysfunction, sponsored by University of Virginia. Not yet recruiting. Open to participants aged 4 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by University of Virginia · Not applicable, Interventional, and Treatment
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.
864 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 660 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →University of Virginia is the lead sponsor of 672 studies on the registry; 138 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
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Exclusion Criteria:
Parasacral transcutaneous electric nerve stimulation (TENS)
Other: Parasacral transcutaneous electric nerve stimulation (TENS)
Oxybutynin
Drug: Oxybutynin
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.
Also known as: TENS
Standard second-line therapy (oral anticholinergics)
Also known as: Oral anticholinergics
Efficacy of TENS
The primary endpoint is the change from baseline to 12 weeks in the Vancouver Nonneurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome (NLUTD/DES) Symptom Score (VSS), a validated composite score ranging from 0-54.
Time frame: baseline to completion of treatment (week 12)
Voiding Diary
frequency of voids and incontinence episodes per 24 hours
Time frame: baseline to completion of treatment (week 12)
Comparison of Uroflowmetry changes from baseline to completion of treatment (week 12)
A uroflow test will be performed at baseline and completion of the treatment to evaluate changes in uroflow patterns. Uroflowmetry measure the volume, time, and strength of urine flow and converts it into a graph so it can be compared against a normal for age and sex. It can also be used to evaluate changes in voiding patterns in the same person over time. The outcome measures will be: * Pre-void bladder volume * Post-void bladder volume * Flow Curve Pattern * Time to Max Flow * Max Flow Rate * Average Flow Rate * Voided Volume * Franco Flow Index * EMG Used: yes/no If yes: EMG lag time present: yes/no EMG activation during voiding: yes/no
Time frame: baseline to completion of treatment (week 12)
Patient Questionnaires
Questionnaires will assess treatment adherence, perceived importance of medication use, ease of treatment administration, symptom relief, quality of life, treatment preferences, and treatment tolerability. Individual questionnaire items are scored using ordinal scales ranging from 1 to 4 or 1 to 5, depending on the assessment domain. For treatment adherence and ease of use, higher scores indicate less favorable outcomes, including poorer treatment adherence and greater difficulty administering treatment. For quality of life, higher scores indicate more favorable outcomes. Higher medication-use importance scores reflect a greater preference for avoiding or reducing medication use and do not directly represent clinical improvement. The symptom relief only uses yes/no answers, so this cannot be scaled.
Time frame: baseline to completion of treatment (week 12)
No study locations are listed for this record.
Plan to share: No — This study protocol is not a multi-site study.
Start is estimated for Sep 2026; primary completion for Sep 2028, 23 months later.
Of 133 non-industry interventional studies with no phase under Urinary Bladder, Overactive, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's planned 23 months is close to that.
Counting every sponsor, half of 174 studies reached it within 19 months; a quarter within 10 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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