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NCT Number: NCT07523477

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.

Recruiting

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location status: Recruiting

Location contact

Ahmad M Shalaby, MBBCH

CONTACT

[email protected]

00201021847979

Mohamed A Omar, MD

SUB_INVESTIGATOR

Mohamed I Elmaadawy, MD

SUB_INVESTIGATOR

Osama M ElGamal, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Botulinium Toxin-A

Drug

Patients will be injected with botulinium toxin-A

Primary outcomes

  1. Success rate

    Time frame: 24 hours postoperatively

    Success rate regarding improvement of clinical symptoms will be recorded.

Secondary outcomes

  1. Incidence of complications

    Time frame: 24 hours postoperatively

    Incidence of complications will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmad M Shalaby, MBBCH

CONTACT

[email protected]

00201021847979

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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