Skip to content

Local Injection of Botulinium Toxin-A in Children With Dysfunctional Voiding or Refractory Nocturnal Eneuresis

Evaluation of Local Injection of Botulinium Toxin-A in Children With Dysfunctional Voiding or Refractory Nocturnal Eneuresis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07523477
Enrollment
64
Registered
2026-04-13
Start date
2025-06-01
Completion date
2026-12-01
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Botulinium Toxin-A, Children, Dysfunctional Voiding, Local Injection, Refractory Nocturnal Eneuresis

Brief summary

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

DRUGBotulinium Toxin-A

Patients will be injected with botulinium toxin-A

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Success rate24 hours postoperativelySuccess rate regarding improvement of clinical symptoms will be recorded.

Secondary

MeasureTime frameDescription
Incidence of complications24 hours postoperativelyIncidence of complications will be recorded.

Countries

Egypt

Contacts

CONTACTAhmad M Shalaby, MBBCH
Ahmed.m.shalaby97@gmail.com00201021847979

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026