Local botulinum toxin‑A injections for children with dysfunctional voiding or persistent bedwetting
Evaluation of Local Injection of Botulinium Toxin-A in Children With Dysfunctional Voiding or Refractory Nocturnal Eneuresis
This will try a local injection of botulinum toxin‑A to see if it helps children with dysfunctional voiding or persistent nighttime bedwetting who haven't improved with standard treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia) |
| Trial ID | NCT07523477 on ClinicalTrials.gov |
What this trial studies
This interventional protocol delivers botulinum toxin‑A injections to the lower urinary tract of children with dysfunctional voiding or refractory monosymptomatic nocturnal enuresis who have not responded to conventional therapy. The procedure is performed under anesthesia and excludes children with bleeding disorders, neuromuscular disease, active urinary infection, or those unfit for anesthesia. Botulinum toxin‑A acts by inhibiting neurotransmitter release and modulating sensory receptors in the bladder and urethral sphincter to reduce involuntary contractions and improve emptying. The trial is conducted at Tanta University in Tanta, El‑Gharbia, Egypt.
Who should consider this trial
Good fit: Children under 18 with dysfunctional voiding or refractory nocturnal enuresis who have not improved with standard treatments and who are medically fit for anesthesia may be eligible.
Not a fit: Children with bleeding disorders, neuromuscular diseases (e.g., myasthenia gravis), active urinary tract infection, or those unfit for anesthesia are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the injections could reduce involuntary sphincter contractions and bedwetting episodes, lowering post‑void residuals and improving daytime and nighttime urinary control.
How similar studies have performed: Botulinum toxin‑A has shown symptomatic benefit in other pediatric bladder and sphincter dysfunction studies, though data specifically for refractory nocturnal enuresis are more limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children \< 18 years. * Both sexes. * Patients with refractory nocturnal enuresis or dysfunctional voiding who are not responding to the traditional treatment. Exclusion Criteria: * Bleeding disorders. * Neuromusclar disorder(e.g.,Myasthenia gravis). * Patients who are not fit for anaesthesia. * Active urinary tract infection (UTI).
Where this trial is running
Tanta, El-Gharbia
- Tanta University — Tanta, El-Gharbia, Egypt (Recruiting)
Study contacts
- Study coordinator: Ahmad M Shalaby, MBBCH
- Email: Ahmed.m.shalaby97@gmail.com
- Phone: 00201021847979
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.