Sathyamurthy Arunaa, Ramesh Babu, Ramasundaram Madhu, Sambandan Kumaravel
Sacral TENS was associated with higher response rates and fewer adverse effects than oxybutynin in this cohort supporting its role as an effective and well-tolerated therapeutic option for pediatric OAB. Further larger trials are warranted.
AIMS: The aim of this RCT is to compare the efficacy of sacral transcutaneous electrical nerve stimulation (TENS) with oxybutynin in children with overactive bladder (OAB), focusing on subjective & objective treatment response, adverse effects, and relapse rates.
MATERIALS AND METHODS: In this prospective randomized controlled study, 82 children aged 5-18 years with refractory OAB were randomized to receive either sacral TENS (30 sessions; 20 min each (10 Hz) daily; for 4 weeks) or oral oxybutynin (0.2 mg/kg/day for 4 weeks). Outcomes were assessed using subjective response categories based on bladder diaries and objective measures including the Overactive Bladder Index (OABI) and Dysfunctional Voiding Symptom Score (DVSS). Adverse effects and relapse during 6-12 months of follow-up were recorded.
RESULTS: There was no significant difference between age/sex distributions between the groups. Median follow-up was 9 (6-12) months. Complete response was significantly higher with TENS than oxybutynin (68.3% vs. 31.7%; OR 4.63, 95% CI 1.8-11.7; p = 0.001). Mean improvement in OABI (4.6 ± 1.4 vs. 3.7 ± 1.0; p = 0.001) and DVSS (8.8 ± 1.5 vs. 5.7 ± 1.3; p = 0.001) favored TENS. Adverse effects (4.9% vs. 46.3%) and relapse rates (7.3% vs. 29.3%) were significantly lower with TENS.
CONCLUSION: Sacral TENS was associated with higher response rates and fewer adverse effects than oxybutynin in this cohort supporting its role as an effective and well-tolerated therapeutic option for pediatric OAB. Further larger trials are warranted.