Primary Monosymptomatic Nocturnal EnuresisNCT07776977
Bedtime Device Restriction and Desmopressin in PMNE.
A study testing Desmopressin and Bedtime digital-device restriction in people with Primary Monosymptomatic Nocturnal Enuresis, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This randomized controlled trial will evaluate whether restricting bedtime digital-device use improves the response to desmopressin in children with primary monosymptomatic nocturnal enuresis. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Primary Monosymptomatic Nocturnal Enuresis
- What is being tested?
- Desmopressin and Bedtime digital-device restriction
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2026to Jul 2027
- 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 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6-14 years.
- Diagnosis of PMNE (≥2 wet nights/week for ≥6 months, no daytime symptoms, no prior sustained dryness >6 months).
- Willingness to take oral desmopressin nightly for 8 weeks.
- Parent/guardian able to monitor and report screen time and wet nights.
- Written informed consent from parent/guardian and assent from child (if age-appropriate).
Who cannot join
- Secondary enuresis or non-monosymptomatic enuresis (daytime incontinence, urgency, frequency).
- Known organic causes (e.g., diabetes mellitus, urinary tract anomalies, neurological disorders).
- Current use of other enuresis treatments (alarms, anticholinergics, imipramine) within 4 weeks prior to enrollment.
- Severe sleep disorders (e.g., obstructive sleep apnea) or psychiatric conditions affecting compliance.
- Inability to comply with study procedures or follow-up.
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
Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
Cairo
Abul-fotouh Ahmed, +201001066756, abulfotouhahmed@yahoo.com
About this study
Official title: Effect of Bedtime Digital-Device Restriction on the Therapeutic Response to Desmopressin in Children With Primary Monosymptomatic Nocturnal Enuresis: A Randomized Controlled Trial
This randomized controlled trial will evaluate whether restricting bedtime digital-device use improves the response to desmopressin in children with primary monosymptomatic nocturnal enuresis. Participants will receive desmopressin for 8 weeks and will be assigned to either bedtime device restriction or usual screen habits.
Read the detailed description
This is a prospective, parallel-group, open-label randomized controlled trial conducted at Al-Hussein and Sayed Galal Hospitals, Al-Azhar University, Cairo, Egypt. Children aged 6-14 years with primary monosymptomatic nocturnal enuresis will be enrolled and randomized 1:1 to receive desmopressin plus bedtime digital-device restriction or desmopressin with no restriction.
The intervention group will avoid digital devices, including smartphones, tablets, televisions, computers, and video games, for at least 60 minutes before habitual bedtime. The control group will continue the usual screen habits. All participants will receive oral desmopressin at bedtime for 8 weeks, with dose adjustment allowed according to clinical response.
The primary outcome is the proportion of participants achieving full response, defined as no more than 1 wet night during the last 2 weeks of treatment. Secondary outcomes include reduction in wet nights per week, partial response rate, sleep quality, adherence, and relapse 4 weeks after treatment discontinuation. Baseline demographic, clinical, and sleep-related data will also be collected to explore predictors of treatment response.
- Being tested
- Desmopressin, Bedtime digital-device restriction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesmopressinDrug
Oral desmopressin administered at bedtime for 8 weeks for treatment of primary monosymptomatic nocturnal enuresis.
Bedtime digital-device restrictionBehavioural
Restriction of digital-device use, including smartphones, tablets, televisions, computers, and video games, for at least 60 minutes before habitual bedtime during the 8-week treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Desmopressin plus bedtime device restriction | Experimental | Participants will receive oral desmopressin at bedtime for 8 weeks and will avoid digital-device use, including smartphones, tablets, televisions, computers, and video games, for at least 60 minutes before habitual bedtime. Receives: Drug: Desmopressin; Behavioral: Bedtime digital-device restriction |
| Desmopressin only | Active comparator | Participants will receive oral desmopressin at bedtime for 8 weeks and will continue their usual bedtime digital-device habits without restriction. Receives: Drug: Desmopressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Full Response Rate
Proportion of participants achieving full response, defined as no more than 1 wet night during the last 2 weeks of the 8-week treatment period.
Measured: Week 8, based on the final 2 weeks of treatment
Secondary outcomes (5)
Change in Wet Nights per Week
Change from baseline in the average number of wet nights per week, calculated from the participant's wet-night diary.
Measured: Baseline to Week 8
Relapse Rate After Treatment
Proportion of participants with recurrence of at least 2 wet nights per week after stopping treatment.
Measured: 4 weeks after treatment discontinuation.
Adherence to Bedtime Device Restriction
Proportion of nights in which participants in the intervention group avoided digital-device use for at least 60 minutes before bedtime, based on parental log.
Measured: During the 8-week treatment period
Desmopressin Adherence
Proportion of prescribed desmopressin doses taken during the 8-week treatment period, based on parental report and pill count.
Measured: During the 8-week treatment period.
Adverse Effects of Desmopressin
Proportion of participants experiencing adverse effects related to desmopressin, including headache, nausea, vomiting, hyponatremia symptoms, excessive thirst, fluid retention, or any other treatment-emergent adverse event.
Measured: During the 8-week treatment period and 4 weeks after treatment discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start20 Aug 2026
- Primary completionMay 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Monosymptomatic 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abul-fotouh Ahmed, Al-Azhar University
- Investigators
- Abul-fotouh Ahmed, Principal investigator, Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776977
- Sponsor's protocol ID
- UroAzhar_10_026
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bedtime Digital-Device Restriction on the Therapeutic Response to Desmopressin in Children With Primary Monosymptomatic Nocturnal Enuresis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07776977
- Acronym / sponsor ID
- UroAzhar_10_026
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 20 Aug 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 20 Aug 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.
This randomized controlled trial will evaluate whether restricting bedtime digital-device use improves the response to desmopressin in children with primary monosymptomatic nocturnal enuresis. Participants will receive desmopressin for 8 weeks and will be assigned to either bedtime device restriction or usual screen habits.
Detailed description
This is a prospective, parallel-group, open-label randomized controlled trial conducted at Al-Hussein and Sayed Galal Hospitals, Al-Azhar University, Cairo, Egypt. Children aged 6-14 years with primary monosymptomatic nocturnal enuresis will be enrolled and randomized 1:1 to receive desmopressin plus bedtime digital-device restriction or desmopressin with no restriction.
The intervention group will avoid digital devices, including smartphones, tablets, televisions, computers, and video games, for at least 60 minutes before habitual bedtime. The control group will continue the usual screen habits. All participants will receive oral desmopressin at bedtime for 8 weeks, with dose adjustment allowed according to clinical response.
The primary outcome is the proportion of participants achieving full response, defined as no more than 1 wet night during the last 2 weeks of treatment. Secondary outcomes include reduction in wet nights per week, partial response rate, sleep quality, adherence, and relapse 4 weeks after treatment discontinuation. Baseline demographic, clinical, and sleep-related data will also be collected to explore predictors of treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desmopressin plus bedtime device restriction | Experimental | Drug: Desmopressin, Behavioral: Bedtime digital-device restrictionParticipants will receive oral desmopressin at bedtime for 8 weeks and will avoid digital-device use, including smartphones, tablets, televisions, computers, and video games, for at least 60 minutes before habitual bedtime. |
| Desmopressin only | Active comparator | Drug: DesmopressinParticipants will receive oral desmopressin at bedtime for 8 weeks and will continue their usual bedtime digital-device habits without restriction. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 6-14 years.
- Diagnosis of PMNE (≥2 wet nights/week for ≥6 months, no daytime symptoms, no prior sustained dryness >6 months).
- Willingness to take oral desmopressin nightly for 8 weeks.
- Parent/guardian able to monitor and report screen time and wet nights.
- Written informed consent from parent/guardian and assent from child (if age-appropriate).
Key exclusion criteria (5 listed)
- Secondary enuresis or non-monosymptomatic enuresis (daytime incontinence, urgency, frequency).
- Known organic causes (e.g., diabetes mellitus, urinary tract anomalies, neurological disorders).
- Current use of other enuresis treatments (alarms, anticholinergics, imipramine) within 4 weeks prior to enrollment.
- Severe sleep disorders (e.g., obstructive sleep apnea) or psychiatric conditions affecting compliance.
- Inability to comply with study procedures or follow-up.
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 |
|---|---|---|
| DesmopressinOral desmopressin administered at bedtime for 8 weeks for treatment of primary monosymptomatic nocturnal enuresis. | Drug | Desmopressin only, Desmopressin plus bedtime device restriction |
| Bedtime digital-device restrictionRestriction of digital-device use, including smartphones, tablets, televisions, computers, and video games, for at least 60 minutes before habitual bedtime during the 8-week treatment period. | Behavioural | Desmopressin plus bedtime device restriction |
Primary outcome
Full Response Rate
Time frame: Week 8, based on the final 2 weeks of treatment
Proportion of participants achieving full response, defined as no more than 1 wet night during the last 2 weeks of the 8-week treatment period.
5 secondary outcomes
Change in Wet Nights per Week
Time frame: Baseline to Week 8
Relapse Rate After Treatment
Time frame: 4 weeks after treatment discontinuation.
Adherence to Bedtime Device Restriction
Time frame: During the 8-week treatment period
Desmopressin Adherence
Time frame: During the 8-week treatment period.
Adverse Effects of Desmopressin
Time frame: During the 8-week treatment period and 4 weeks after treatment discontinuation
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 24 Aug 2026.
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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.
Abul-fotouh Ahmed principal investigator
Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
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 and Bedtime digital-device restriction in people with Primary Monosymptomatic 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 5 inclusion and 5 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 24 Aug 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 Abul-fotouh Ahmed (+201001066756, abulfotouhahmed@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Full Response Rate (time frame: Week 8, based on the final 2 weeks of treatment). 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 24 Aug 2026.