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

April 5, 2026 updated by: Ahmad Mohamed Elsaied Shalaby, Tanta University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • El-Gharbia
      • Tanta, El-Gharbia, Egypt, 31527
        • Recruiting
        • Tanta University
        • Contact:
        • Sub-Investigator:
          • Osama M ElGamal, MD
        • Sub-Investigator:
          • Mohamed A Omar, MD
        • Sub-Investigator:
          • Mohamed I Elmaadawy, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Children with refractory nocturnal enuresis or dysfunctional voiding.
Drug: Botulinium Toxin-A
Patients will be injected with botulinium toxin-A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate
Time Frame: 24 hours postoperatively
Success rate regarding improvement of clinical symptoms will be recorded.
24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of complications
Time Frame: 24 hours postoperatively
Incidence of complications will be recorded.
24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 5, 2026

First Submitted That Met QC Criteria

April 5, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 5, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 36264MS952/5/25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Children

Clinical Trials on Botulinium Toxin-A

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe