NCT07523477

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress62%
Jun 2025Dec 2026

Study Start

First participant enrolled

June 1, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

April 5, 2026

Last Update Submit

April 5, 2026

Conditions

Local InjectionChildrenRefractory Nocturnal EneuresisBotulinium Toxin-ADysfunctional Voiding

Outcome Measures

Primary Outcomes (1)

  • Success rate

    Success rate regarding improvement of clinical symptoms will be recorded.

    24 hours postoperatively

Secondary Outcomes (1)

  • Incidence of complications

    24 hours postoperatively

Study Arms (1)

Study group

EXPERIMENTAL

Children with refractory nocturnal enuresis or dysfunctional voiding.

Drug: Botulinium Toxin-A

Interventions

Botulinium Toxin-ADRUG

Patients will be injected with botulinium toxin-A

Study group

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children \< 18 years.
  • Both sexes.
  • Patients with refractory nocturnal enuresis or dysfunctional voiding who are not responding to the traditional treatment.

You may not qualify if:

  • Bleeding disorders.
  • Neuromusclar disorder(e.g.,Myasthenia gravis).
  • Patients who are not fit for anaesthesia.
  • Active urinary tract infection (UTI).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

Central Study Contacts

Ahmad M Shalaby, MBBCH

CONTACT

00201021847979Ahmed.m.shalaby97@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Urology, Tanta University, Tanta, Egypt

Study Record Dates

First Submitted

April 5, 2026

First Posted

April 13, 2026

Study Start

June 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations

EG(1)