Local InjectionNCT07523477
Local Injection of Botulinium Toxin-A in Children With Dysfunctional Voiding or Refractory Nocturnal Eneuresis
A study testing Botulinium Toxin-A in people with Local Injection and Botulinium Toxin-A, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Local Injection, Botulinium Toxin-A, Children
- What is being tested?
- Botulinium Toxin-A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children < 18 years.
- Both sexes.
- Patients with refractory nocturnal enuresis or dysfunctional voiding who are not responding to the traditional treatment.
Who cannot join
- Bleeding disorders.
- Neuromusclar disorder(e.g.,Myasthenia gravis).
- Patients who are not fit for anaesthesia.
- Active urinary tract infection (UTI).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Ahmad M Shalaby, MBBCH, 00201021847979, Ahmed.m.shalaby97@gmail.com
Osama M ElGamal, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Local Injection, Botulinium Toxin-A, Children, Dysfunctional Voiding, Refractory Nocturnal Eneuresis
- Being tested
- Botulinium Toxin-A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinium Toxin-ADrug
Patients will be injected with botulinium toxin-A
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Children with refractory nocturnal enuresis or dysfunctional voiding. Receives: Drug: Botulinium Toxin-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
Success rate regarding improvement of clinical symptoms will be recorded.
Measured: 24 hours postoperatively
Secondary outcomes (1)
Incidence of complications
Incidence of complications will be recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Jun 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local InjectionStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Mohamed Elsaied Shalaby, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523477
- Sponsor's protocol ID
- 36264MS952/5/25
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Local Injection of Botulinium Toxin-A in Children With Dysfunctional Voiding or Refractory Nocturnal Eneuresis
- ClinicalTrials.gov ID
- NCT07523477
- Acronym / sponsor ID
- 36264MS952/5/25
- Conditions
- Local Injection, Botulinium Toxin-A, Children, Dysfunctional Voiding, Refractory Nocturnal Eneuresis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: Botulinium Toxin-AChildren with refractory nocturnal enuresis or dysfunctional voiding. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children < 18 years.
- Both sexes.
- Patients with refractory nocturnal enuresis or dysfunctional voiding who are not responding to the traditional treatment.
Key exclusion criteria (4 listed)
- Bleeding disorders.
- Neuromusclar disorder(e.g.,Myasthenia gravis).
- Patients who are not fit for anaesthesia.
- Active urinary tract infection (UTI).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinium Toxin-APatients will be injected with botulinium toxin-A | Drug | Study group |
Primary outcome
Success rate
Time frame: 24 hours postoperatively
Success rate regarding improvement of clinical symptoms will be recorded.
1 secondary outcome
Incidence of complications
Time frame: 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinium Toxin-A in people with Local Injection and Botulinium Toxin-A, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmad M Shalaby, MBBCH (00201021847979, Ahmed.m.shalaby97@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.