Nocturnal EnuresisNCT06285006
Desmopressin Monotherapy for Monosymptomatic Nocturnal Enuresis
A study testing Desmopressin in people with Nocturnal Enuresis, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Nocturnal Enuresis (NE) is defined as the involuntary passage of urine during sleep past the age of usual control, which is considered a developmental age of 5 to 7 years. NE is a common problem that causes distress to both children and their families. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Nocturnal Enuresis
- What is being tested?
- Desmopressin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Feb 2024to 12 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- School age group (from 7 to 14 years)
- Primary monosymptomatic nocturnal enuresis
Who cannot join
- Patients with one or more of the following will be excluded from the study.
- Diurnal enuresis
- Urinary tract infection within the preceding 3 months
- Diabetes mellitus
- History of renal disease, hypertension or genitourinary abnormality, neurological disease, or psychological disease.
- Post-micturition residual urine >1/3 expected bladder capacity.
- Each patient will be subjected to the following.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alazhar university
Asyut, 11884
Omnia Nassar, Dr, 01010112054, omnianassar835@gmail.com
Hosny Elmasry, Prof, 01010112054, omnianassar835@gmail.com
About this study
Official title: Predictors of Success and Relapse After Desmopressin Monotherapy for Monosymptomatic Nocturnal Enuresis
Nocturnal Enuresis (NE) is defined as the involuntary passage of urine during sleep past the age of usual control, which is considered a developmental age of 5 to 7 years.
NE is a common problem that causes distress to both children and their families. It has an adverse impact on behavior and social life, affects self-esteem, and can result in poor emotional well-being. In Egypt, the prevalence of NE in primary school children is about 15.4%. The family history was seen to have had a markedly significant impact on the occurrence of NE in the studied children. The mainstay of treatment is urotherapy with information and psychoeducation about normal lower urinary tract function, the underlying cause of MNE, disturbed bladder dysfunction in the child with NMNE, and instructions about therapeutic strategies. Alarm therapy and desmopressin are effective in randomized trials. Children with NMNE first need treatment of the underlying daytime functional bladder problem before treatment of nocturnal enuresis.
- Conditions
- Nocturnal Enuresis
- Being tested
- Desmopressin
- Keywords
- Nocturnal enuresis, Desmopressin, Monotherapy
- Medical subject headings
- Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesmopressinDrug
Desmopressin is a synthetic analogue of ADH released by the posterior pituitary gland that reduces urine production by increasing water reabsorption by the collecting tubules.
| Study group | Role | What they receive |
|---|---|---|
| Desmopressin | Experimental | Desmopressin is a synthetic analogue of ADH released by the posterior pituitary gland that reduces urine production by increasing water reabsorption by the collecting tubules. Receives: Drug: Desmopressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of episodes per week after desmopressin treatment
Patients will be evaluate by no. of episodes per week after desmopressin treatment.
Measured: After the end of the treatment for one month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start23 Feb 2024
- Primary completion1 May 2024 (estimated)
- Study completion12 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nocturnal EnuresisStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hosny Mohamed Ahmed Elmasry, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285006
- Sponsor's protocol ID
- MScAZASTPED025/23/202/12/2021
- Status last verified
- Apr 2024
- First submitted
- 22 Feb 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Success and Relapse After Desmopressin Monotherapy for Monosymptomatic Nocturnal Enuresis
- ClinicalTrials.gov ID
- NCT06285006
- Acronym / sponsor ID
- MScAZASTPED025/23/202/12/2021
- Conditions
- Nocturnal Enuresis
- Keywords
- Nocturnal enuresis, Desmopressin, Monotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 12 May 2024 (estimated)
- First posted
- 29 Feb 2024 (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.
Nocturnal Enuresis (NE) is defined as the involuntary passage of urine during sleep past the age of usual control, which is considered a developmental age of 5 to 7 years.
NE is a common problem that causes distress to both children and their families. It has an adverse impact on behavior and social life, affects self-esteem, and can result in poor emotional well-being. In Egypt, the prevalence of NE in primary school children is about 15.4%. The family history was seen to have had a markedly significant impact on the occurrence of NE in the studied children. The mainstay of treatment is urotherapy with information and psychoeducation about normal lower urinary tract function, the underlying cause of MNE, disturbed bladder dysfunction in the child with NMNE, and instructions about therapeutic strategies. Alarm therapy and desmopressin are effective in randomized trials. Children with NMNE first need treatment of the underlying daytime functional bladder problem before treatment of nocturnal enuresis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Desmopressin | Experimental | Drug: DesmopressinDesmopressin is a synthetic analogue of ADH released by the posterior pituitary gland that reduces urine production by increasing water reabsorption by the collecting tubules. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- School age group (from 7 to 14 years)
- Primary monosymptomatic nocturnal enuresis
Key exclusion criteria (7 listed)
- Patients with one or more of the following will be excluded from the study.
- Diurnal enuresis
- Urinary tract infection within the preceding 3 months
- Diabetes mellitus
- History of renal disease, hypertension or genitourinary abnormality, neurological disease, or psychological disease.
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 |
|---|---|---|
| DesmopressinDesmopressin is a synthetic analogue of ADH released by the posterior pituitary gland that reduces urine production by increasing water reabsorption by the collecting tubules. | Drug | Desmopressin |
Primary outcome
The number of episodes per week after desmopressin treatment
Time frame: After the end of the treatment for one month.
Patients will be evaluate by no. of episodes per week after desmopressin treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desmopressin in people with Nocturnal Enuresis, run by Al-Azhar 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 23 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omnia Nassar, Dr (01010112054, omnianassar835@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of episodes per week after desmopressin treatment (time frame: After the end of the treatment for one month.). 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 23 Apr 2024.