Nocturnal EnuresisNCT06185361
Selective Serotonin Reuptake Inhibitors, Fluoxetine Versus the Standard Oral Desmopressin for Management of Mono-symptomatic Nocturnal Enuresis.
A study testing Fluoxetine 20 MG and Desmopressin in people with Nocturnal Enuresis and Enuresis, run by Fayoum University Hospital at 1 site in Egypt.
Trial summary
To determine whether there is a role for the selective serotonin reuptake inhibitors fluoxetine versus desmopressin in the treatment of nocturnal enuresis in children who have not responded to standard nonpharmacological urotherapy, and whether there are side effects involved. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Nocturnal Enuresis, Enuresis, Enuresis, Nocturnal
- What is being tested?
- Fluoxetine 20 MG and Desmopressin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 1 Mar 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ≥ 7 years
- Severe enuresis with at least (50%) seven wet nights out of 14
- Failed treatment
- The enuresis alarm was either ineffective or considered impractical due to the family circumstances.
Who cannot join
- Underlying renal, urologic, neurologic, endocrinologic, or cardiac conditions
- Patients with psychiatric disorders and behavioral disorders including depression, attention-deficit/hyperactivity disorder.
- Untreated constipation
- Contraindications to fluoxetine or desmopressin treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Selective Serotonin Reuptake Inhibitors, Fluoxetine Versus the Standard Oral Desmopressin for Management of Mono-symptomatic Nocturnal Enuresis. A Randomised Controlled Trial
To determine whether there is a role for the selective serotonin reuptake inhibitors fluoxetine versus desmopressin in the treatment of nocturnal enuresis in children who have not responded to standard nonpharmacological urotherapy, and whether there are side effects involved.
- Conditions
- Nocturnal Enuresis, Enuresis, Enuresis, Nocturnal
- Being tested
- Fluoxetine 20 MG, Desmopressin
- Medical subject headings
- Nocturnal Enuresis, Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoxetine 20 MGDrug
fluoxetine
DesmopressinDrug
desmopressin
| Study group | Role | What they receive |
|---|---|---|
| fluoxetine | Active comparator | selective serotonin reuptake inhibitors fluoxetine 20 mg for 12 weeks Receives: Drug: Fluoxetine 20 MG |
| desmopressin | Active comparator | 0.2 mg desmopressin tablet for 12 weeks Receives: Drug: Desmopressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The children will be non-responders, partial responders, or full responders to therapy
The standardization of terminology of lower urinary tract function in children and adolescents: Update report from the standardization committee of the International Children's Continence Society "ICCS definitions" (i.e., if the reduction of enuresis frequency was below or above 50% or 90%, respectively)
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start1 Dec 2022
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 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.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hesham Abdel Azim El Helaly, Fayoum University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185361
- Sponsor's protocol ID
- Nocturnal Enuresis
- Status last verified
- Dec 2023
- First submitted
- 15 Dec 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Serotonin Reuptake Inhibitors, Fluoxetine Versus the Standard Oral Desmopressin for Management of Mono-symptomatic Nocturnal Enuresis. A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06185361
- Acronym / sponsor ID
- Nocturnal Enuresis
- Conditions
- Nocturnal Enuresis, Enuresis, Enuresis, Nocturnal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 29 Dec 2023 (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.
To determine whether there is a role for the selective serotonin reuptake inhibitors fluoxetine versus desmopressin in the treatment of nocturnal enuresis in children who have not responded to standard nonpharmacological urotherapy, and whether there are side effects involved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fluoxetine | Active comparator | Drug: Fluoxetine 20 MGselective serotonin reuptake inhibitors fluoxetine 20 mg for 12 weeks |
| desmopressin | Active comparator | Drug: Desmopressin0.2 mg desmopressin tablet for 12 weeks |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age ≥ 7 years
- Severe enuresis with at least (50%) seven wet nights out of 14
- Failed treatment
- The enuresis alarm was either ineffective or considered impractical due to the family circumstances.
Key exclusion criteria (4 listed)
- Underlying renal, urologic, neurologic, endocrinologic, or cardiac conditions
- Patients with psychiatric disorders and behavioral disorders including depression, attention-deficit/hyperactivity disorder.
- Untreated constipation
- Contraindications to fluoxetine or desmopressin treatment
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 |
|---|---|---|
| Fluoxetine 20 MGfluoxetine | Drug | fluoxetine |
| Desmopressindesmopressin | Drug | desmopressin |
Primary outcome
The children will be non-responders, partial responders, or full responders to therapy
Time frame: three months
The standardization of terminology of lower urinary tract function in children and adolescents: Update report from the standardization committee of the International Children's Continence Society "ICCS definitions" (i.e., if the reduction of enuresis frequency was below or above 50% or 90%, respectively)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoxetine 20 MG and Desmopressin in people with Nocturnal Enuresis and Enuresis, run by Fayoum University Hospital 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 4 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: status not confirmed, as of the sponsor's last update on 29 Dec 2023. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The children will be non-responders, partial responders, or full responders to therapy (time frame: three months). 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 29 Dec 2023.