Local Injection of Botulinium Toxin-A in Children With Dysfunctional Voiding or Refractory Nocturnal Eneuresis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Botulinium Toxin-A.
- Who it may be relevant to
- Registry conditions: Local Injection, Botulinium Toxin-A, Children, Dysfunctional Voiding. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Local Injection of Botulinium Toxin-A in Children With Dysfunctional Voiding or Refractory Nocturnal Eneuresis
Overview
The aim of this study is to evaluate the outcome of botulinum toxin A (BTX-A) injection for management of children with : A-Dysfunctional voiding who are not responding to traditional treatment. B-Refractory nocturnal enuresis.
Detailed description
Dysfunctional voiding (DV) is a habitual voiding disorder caused by involuntary contraction or non relaxation of the external urethral sphincter (EUS) during voiding.
This contraction causes high post void residuals (PVR), The disorder can occur at any age. In young children it often presents as urinary incontinence, nocturnal enuresis, or recurrent urinary tract infections (UTIs).
Nocturnal enuresis (NE) is common, affecting 15-20 % of children by five years old, and 8-10 % of children by eight years old.
Refractory nocturnal enuresis is defined as monosymptomatic nocturnal enuresis (bedwetting without daytime urinary symptoms) that persists despite at least 3-6 months of appropriate and compliant first line therapy.
Botulinum toxin has been found to inhibit the release of a number of neurotransmitters (including acetylcholine, adenosine triphosphate, and neuropeptides such as substance P) and to down regulate the expression of purinergic and capsaicin receptors on afferent neurons within the bladder.
Interventions
- Drug Botulinium Toxin-A
Patients will be injected with botulinium toxin-A
Primary outcome measures
- Success rate [Time frame: 24 hours postoperatively]
Secondary outcome measures (1)
- Incidence of complications [Time frame: 24 hours postoperatively]
Eligibility 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Tanta University — Tanta
Identifiers
NCT: NCT07523477 · 36264MS952/5/25