Oxybutynin versus posterior tibial nerve stimulation for children with idiopathic overactive bladder
Official title: Comparative Study of the Efficacy of Treatment of Idiopathic Overactive Bladder (OAB) in Children: Oxybutynine vs. Transcutaneous Neurostimulation
Run by Centre Hospitalier Universitaire, Amiens · NCT07030803 · Data updated 2026-11-12
This trial will test whether weekly posterior tibial nerve stimulation works as well as daily oxybutynin for treating idiopathic overactive bladder in children aged 6–16.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 16 Years |
| Sex | All |
| Enrollment | 124 (estimated) |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Status | Recruiting |
| Started | November 5, 2025 |
| Main results expected | March 2029 |
| Study ends | March 2029 |
| Registry record updated | November 18, 2025 |
| Trial ID | NCT07030803 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 6 to 16 with idiopathic overactive bladder who have followed urotherapy for at least one month and have not had active treatment in the prior three months are ideal candidates.
✕Probably not a fit
Children with neurological bladder causes, significant post-void residuals, recurrent urinary tract infections, recent pelvic surgery, severe treatment-resistant constipation, pregnancy/breastfeeding, or contraindications to oxybutynin or TENS are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Children who still have overactive bladder after at least one month of urotherapy will be randomly assigned to receive either oral oxybutynin or posterior tibial nerve stimulation using the Urostim device. The trial is designed as a non-inferiority comparison over three months of treatment to see if nerve stimulation provides similar symptom control to the reference drug. Prior to randomization, infectious, urological, and neurological causes are excluded and standard urotherapy instructions are reinforced. Outcomes will focus on urinary frequency, urgency, daytime leakage, and tolerability of the two approaches.
Why it matters
Potential benefit: If successful, children could have an effective non-drug option that may avoid anticholinergic side effects while controlling symptoms.
How similar studies have gone: Small studies and clinical use support posterior tibial nerve stimulation in children, but high-quality head-to-head trials versus oxybutynin have been lacking until now.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
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CHRU Amiens
Amiens, France Recruiting
Study contacts
- Study coordinator: Elodie Haraux, Pr
- Email: Haraux.elodie@chu-amiens.fr
- Phone: 33+322836787
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.