Comparative Study of the Efficacy of Treatment of Idiopathic Overactive Bladder (OAB) in Children: Oxybutynine vs. Transcutaneous Neurostimulation

Launched by CENTRE HOSPITALIER UNIVERSITAIRE, AMIENS · Jun 12, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at two ways to treat children with a condition called idiopathic overactive bladder (OAB), which means their bladder is very active without any known infection or nerve problems causing it. The study compares a common medication called oxybutynin with a newer treatment called posterior tibial nerve stimulation (PTNS), a type of gentle electrical stimulation applied near the ankle to help calm the bladder. The goal is to see if PTNS works just as well and is as easy to tolerate as the medication after three months of treatment.

Children aged 6 to 16 who have symptoms like frequent urination, sudden urges to go, daytime urine leakage, or waking up at night to urinate may be able to join the study. Before starting, they’ll have tried basic bladder training techniques for at least a month. If eligible, participants will be randomly assigned to either take the medication or receive the nerve stimulation treatment. Throughout the study, doctors will monitor how well the treatment works, any side effects, and how well the child follows the treatment plan. Families interested in this study should know that it aims to find effective, safe options to improve children’s bladder control and quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients aged 6 to 16 years
• • Showing signs of OAB (pollakiuria (\> 8 micturitions/d and/or urgenturia(\>x2/week) and/or daytime urine leakage (1/d) and/or nocturia x2/night)
• • No treatment for more than 3 months
• • Urotherapy rules followed for at least 1 month
• • Beneficiary of a social security plan
• • Signature of consent by parents/legal guardian(s) and child's agreement
• Exclusion Criteria:
• • Neurological cause of bladder dysfunction,
• • History of pelvic surgery,
• • Significant post-micturition residual (\> 10% of micturition),
• • Recurrent urinary tract infections (\> 3) in the 6 months prior to inclusion or urinary tract infection at inclusion.
• • Pregnant or breast-feeding adolescents
• • Severe constipation resistant to treatment (Rome IV),
• • Contraindication to oxybutynin
• • Contraindication to the use of TENS (Urostim)