Voiding DysfunctionNCT07067957
Prevalence of Functional Lower Urinary Tract Voiding Dysfunction in School-Aged Children
An observational study of Voiding Dysfunction and Urinary Incontinence, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to investigate the prevalence of voiding disorders and the related risk factors for the primary school-age children in El Ghrbia Government Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Voiding Dysfunction, Urinary Incontinence, Urination Disorders
- What is being tested?
- Arabic Dysfunctional Voiding Symptom Score Questionnaire (DVSS)
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2025to 30 Nov 2025
- Phase
- Observational
- 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 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: School-aged children (4-14 years) attending primary schools in El Gharbia Governorate, Egypt, during the study period.
Who may be able to join
- Children aged 4-14 years old in our locality.
Who cannot join
- Children with known anatomical anomalies of urinary tract
- Children with known neurological anomalies (spinal dysraphism, multiple sclerosis, lumbar or spinal neuritis……… etc)
- Children with history of back or lower urinary tract trauma
- Parents who refuse participation
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
Tanta University
Tanta, El-Gharbia, 31527
Mohamed I Elmaadawy, MD, 00201060245430, Mohamed.elmaadawy@med.tanta.edu.eg
About this study
The aim of this study is to investigate the prevalence of voiding disorders and the related risk factors for the primary school-age children in El Ghrbia Government
Read the detailed description
Lower urinary tract dysfunction (LUTD) is classified as a storage and voiding symptoms. Storage symptoms are increased or decreased urinary frequency, urinary incontinence, urinary urgency, and nocturia. Voiding symptoms are classified as hesitation, straining, weak stream, and intermittency. Other symptoms are holding maneuvers, feeling of incomplete emptying, postmicturition dribble, and genital and lower urinary tract pain. Constipation and/or fecal incontinence are closely related to LUTD, among children over 5 years due to functional or nonorganic causes.
The exact prevalence of the lower urinary tract dysfunction (LUTD) is unknown, approximately 20% to 30% of children in the world have symptoms associated with voiding disorders. In epidemiological studies, this ratio is between 2.1% and 19.2% in school-age children.Due to the modern lifestyle, the prevalence increases secondary to changes in toilet training and habits.
- Conditions
- Voiding Dysfunction, Urinary Incontinence, Urination Disorders, Lower Urinary Tract Symptoms, Pediatrics, Constipation
- Being tested
- Arabic Dysfunctional Voiding Symptom Score Questionnaire (DVSS)
- Medical subject headings
- Urinary Incontinence, Urination Disorders, Lower Urinary Tract Symptoms, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arabic Dysfunctional Voiding Symptom Score Questionnaire (DVSS)Other
A validated Arabic version of the Dysfunctional Voiding Symptom Score Questionnaire (DVSS) questionnaire will be used to screen children for symptoms of lower urinary tract dysfunction. It includes 10 items assessing urinary and bowel habits.
| Study group | Role | What they receive |
|---|---|---|
| Study group | School-aged Children Receives: Other: Arabic Dysfunctional Voiding Symptom Score Questionnaire (DVSS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Voiding Dysfunction
Prevalence of Voiding Dysfunction Among School-Aged Children will be Measured using the validated Arabic version of the Dysfunctional Voiding Symptom Score (DVSS). Children with a score above the diagnostic threshold will be considered as having voiding dysfunction.
Measured: 1 Hour after completion of the questionnaire
Secondary outcomes (1)
Frequency of Constipation in Children With Voiding Dysfunction
Constipation history will be identified through the Dysfunctional Voiding Symptom Score (DVSS) questionnaire and confirmed during clinical evaluation.
Measured: 1 Hour after completion of the questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start10 Jul 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voiding DysfunctionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ibrahim Ahmed Elmaadawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067957
- Sponsor's protocol ID
- 36264PR1073/1/25
- Status last verified
- Jul 2025
- First submitted
- 6 Jul 2025
- Last updated
- 16 Jul 2025
- 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 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Functional Lower Urinary Tract Voiding Dysfunction in School-Aged Children
- ClinicalTrials.gov ID
- NCT07067957
- Acronym / sponsor ID
- 36264PR1073/1/25
- Conditions
- Voiding Dysfunction, Urinary Incontinence, Urination Disorders, Lower Urinary Tract Symptoms, Pediatrics, Constipation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Jul 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 16 Jul 2025 (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 investigate the prevalence of voiding disorders and the related risk factors for the primary school-age children in El Ghrbia Government
Detailed description
Lower urinary tract dysfunction (LUTD) is classified as a storage and voiding symptoms. Storage symptoms are increased or decreased urinary frequency, urinary incontinence, urinary urgency, and nocturia. Voiding symptoms are classified as hesitation, straining, weak stream, and intermittency. Other symptoms are holding maneuvers, feeling of incomplete emptying, postmicturition dribble, and genital and lower urinary tract pain. Constipation and/or fecal incontinence are closely related to LUTD, among children over 5 years due to functional or nonorganic causes.
The exact prevalence of the lower urinary tract dysfunction (LUTD) is unknown, approximately 20% to 30% of children in the world have symptoms associated with voiding disorders. In epidemiological studies, this ratio is between 2.1% and 19.2% in school-age children.Due to the modern lifestyle, the prevalence increases secondary to changes in toilet training and habits.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Arabic Dysfunctional Voiding Symptom Score Questionnaire (DVSS)School-aged Children |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- School-aged children (4-14 years) attending primary schools in El Gharbia Governorate, Egypt, during the study period.
Key inclusion criteria (1 listed)
- Children aged 4-14 years old in our locality.
Key exclusion criteria (4 listed)
- Children with known anatomical anomalies of urinary tract
- Children with known neurological anomalies (spinal dysraphism, multiple sclerosis, lumbar or spinal neuritis……… etc)
- Children with history of back or lower urinary tract trauma
- Parents who refuse participation
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 |
|---|---|---|
| Arabic Dysfunctional Voiding Symptom Score Questionnaire (DVSS)A validated Arabic version of the Dysfunctional Voiding Symptom Score Questionnaire (DVSS) questionnaire will be used to screen children for symptoms of lower urinary tract dysfunction. It includes 10 items assessing urinary and bowel habits. | Other | Study group |
Primary outcome
Prevalence of Voiding Dysfunction
Time frame: 1 Hour after completion of the questionnaire
Prevalence of Voiding Dysfunction Among School-Aged Children will be Measured using the validated Arabic version of the Dysfunctional Voiding Symptom Score (DVSS). Children with a score above the diagnostic threshold will be considered as having voiding dysfunction.
1 secondary outcome
Frequency of Constipation in Children With Voiding Dysfunction
Time frame: 1 Hour after completion of the questionnaire
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 16 Jul 2025.
- 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?
An observational study of Voiding Dysfunction and Urinary Incontinence, 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 1 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: opening soon, as of the sponsor's last update on 16 Jul 2025. 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 Mohamed I Elmaadawy, MD (00201060245430, Mohamed.elmaadawy@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Voiding Dysfunction (time frame: 1 Hour after completion of the questionnaire). 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 16 Jul 2025.