Oxybutynin versus posterior tibial nerve stimulation for children with idiopathic overactive bladder
Comparative Study of the Efficacy of Treatment of Idiopathic Overactive Bladder (OAB) in Children: Oxybutynine vs. Transcutaneous Neurostimulation
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 6 Years to 16 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT07030803 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Amiens
- CHRU Amiens — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Elodie Haraux, Pr
- Email: Haraux.elodie@chu-amiens.fr
- Phone: 33+322836787
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.