Enuresis, NocturnalNCT07015320
The Behavioral Therapy for Primary Monosymptomatic Nocturnal Enuresis
An observational study of Enuresis, Nocturnal, run by Cairo University at 1 site in Egypt.
Trial summary
A prospective randomized clinical study was conducted at Urology departments, faculties of medicine, Fayoum and Cairo Universities. All children either boys or girls between 4-4.5 years old presented with bedtime wetting despite good daytime urine control were included in the study. Read more about this study
- Who is it for?
- Ages 4 to 5 years
- Conditions the study is for
- Enuresis, Nocturnal
- What is being tested?
- urotherapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2023to 30 Dec 2024
- Phase
- Observational
- 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 4 to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: PMNE
Who may be able to join
- PMNE
Who cannot join
- neurogenic bladder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Behavioral and Alarm Therapy for Primary Monosymptomatic Nocturnal Enuresis , a Prospective Randomized Control Trial.
A prospective randomized clinical study was conducted at Urology departments, faculties of medicine, Fayoum and Cairo Universities. All children either boys or girls between 4-4.5 years old presented with bedtime wetting despite good daytime urine control were included in the study. The children who were older than 4.5 years, had daytime voiding dysfunction, had !، behavioural disorders like attention deficient and hyperactivity disorder (ADHD) or other comorbidities like diabetes mellitus (DM) or congenital abnormalities were excluded from the study. In addition, those children whom parents refused to sign the consent of participation were also excluded. 120 children with primary monosymptomatic nocturnal enuresis (PMNE) were initially included in this study and randomized into two groups according to computer generated randomization. Group A (early therapy) included initially 60 child who had done behavioural and alarm therapy from the start of the study regularly till the age of 5.5 years and Group B (deferred therapy) included 60 child who waited without therapy till age of 5 years, then they started the behavioural and alarm therapy regularly for 6 months. They were interviewed at urology clinics in Fayoum and Cairo Universities in Egypt. The behavioural therapy was in the form of prompted and scheduled voiding, regular sleep timing, fluid and caffeine restriction and avoiding the cellular phones 2 hours before bedtime. If the child had constipation, it should be treated. In addition, alarm therapy was performed in the form of awaking the child every night by his parents after 1-2 hours from deep sleep to void then continue the sleep. The parents should be informed about the importance of their psychological support I to their child by avoiding any punishment or embarrassment. Furthermore, the parents were asked to monitor their child's response by documenting the number of wet nights within the last 4 month. All children were then evaluated at the age of 5 and 5.5 years using the following outcomes through the last month before the visit: complete response (0 wet nights), > 80 % stoppage of bedwetting (< 6 wet nights), 50-80 % stoppage of bedwetting (6-15 wet nights) and < 50 % stoppage of bedwetting (> 15 wet nights).
Read the detailed description
A prospective randomized clinical study was conducted at Urology departments, faculties of medicine, Fayoum and Cairo Universities. All children either boys or girls between 4-4.5 years old presented with bedtime wetting despite good daytime urine control were included in the study. The children who were older than 4.5 years, had daytime voiding dysfunction, had behavioural disorders like attention deficient and hyperactivity disorder (ADHD) or other comorbidities like diabetes mellitus (DM) or congenital abnormalities were excluded from the study. In addition, those children whom parents refused to sign the consent of participation were also excluded. 120 children with primary monosymptomatic nocturnal enuresis (PMNE) were initially included in this study. They were randomized into two groups according to computer generated randomization. Group A (early therapy) included initially 60 child who had done behavioural and alarm therapy from the start of the study regularly till the age of 5.5 years and Group B (deferred therapy) included 60 child who waited without therapy till age of 5 years, then they started the behavioural and alarm therapy regularly for 6 months. They were interviewed at urology clinics in Fayoum and Cairo Universities in Egypt. The behavioural therapy was in the form of prompted and scheduled voiding, regular sleep timing, fluid and caffeine restriction and avoiding the cellular phones 2 hours before bedtime. If the child had constipation, it should be treated. In addition, alarm therapy was performed in the form of awaking the child every night by his parents after 1-2 hours from deep sleep to void then continue the sleep. The parents should be informed about the importance of their psychological support to their child by avoiding any punishment or embarrassment. Furthermore, the parents were asked to monitor their child's response by documenting the number of wet nights within the last 4 month. All children were then evaluated at the age of 5 and 5.5 years using the following outcomes through the last month before the visit: complete response (0 wet nights), > 80 % stoppage of bedwetting (< 6 wet nights), 50-80 % stoppage of bedwetting (6-15 wet nights) and < 50 % stoppage of bedwetting (> 15 wet nights).
- Conditions
- Enuresis, Nocturnal
- Being tested
- urotherapy, no intervention
- Keywords
- nocturnal enuresis, behavioural therapy, urotherapy
- Medical subject headings
- Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urotherapyBehavioural
prompted and scheduled voiding, regular sleep timing, fluid and caffeine restriction and avoiding the cellular phones 2 hours before bedtime. If the child had constipation, it should be treated. In addition, alarm therapy was performed in the form of awaking the child every night by his parents after 1-2 hours from deep sleep to void then continue the sleep. The parents should be informed about the importance of their psychological support to their child by avoiding any punishment or embarrassment. Furthermore, the parents were asked to monitor their child's response by documenting the number of wet nights within the last month
no interventionBehavioural
no intervention
| Study group | Role | What they receive |
|---|---|---|
| urotherapy | Not described Receives: Behavioral: urotherapy | |
| control | Not described Receives: Behavioral: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
bed wetting
complete response (0 wet nights), > 80 % stoppage of bedwetting (< 6 wet nights), 50-80 % stoppage of bedwetting (6-15 wet nights) and < 50 % stoppage of bedwetting (> 15 wet nights).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start15 Jan 2023
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enuresis, NocturnalStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelghany, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015320
- Sponsor's protocol ID
- R408
- Status last verified
- Jan 2023
- First submitted
- 30 May 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Behavioral and Alarm Therapy for Primary Monosymptomatic Nocturnal Enuresis , a Prospective Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT07015320
- Acronym / sponsor ID
- R408
- Conditions
- Enuresis, Nocturnal
- Keywords
- nocturnal enuresis, behavioural therapy, urotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 11 Jun 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.
A prospective randomized clinical study was conducted at Urology departments, faculties of medicine, Fayoum and Cairo Universities. All children either boys or girls between 4-4.5 years old presented with bedtime wetting despite good daytime urine control were included in the study. The children who were older than 4.5 years, had daytime voiding dysfunction, had !، behavioural disorders like attention deficient and hyperactivity disorder (ADHD) or other comorbidities like diabetes mellitus (DM) or congenital abnormalities were excluded from the study. In addition, those children whom parents refused to sign the consent of participation were also excluded. 120 children with primary monosymptomatic nocturnal enuresis (PMNE) were initially included in this study and randomized into two groups according to computer generated randomization. Group A (early therapy) included initially 60 child who had done behavioural and alarm therapy from the start of the study regularly till the age of 5.5 years and Group B (deferred therapy) included 60 child who waited without therapy till age of 5 years, then they started the behavioural and alarm therapy regularly for 6 months. They were interviewed at urology clinics in Fayoum and Cairo Universities in Egypt. The behavioural therapy was in the form of prompted and scheduled voiding, regular sleep timing, fluid and caffeine restriction and avoiding the cellular phones 2 hours before bedtime. If the child had constipation, it should be treated. In addition, alarm therapy was performed in the form of awaking the child every night by his parents after 1-2 hours from deep sleep to void then continue the sleep. The parents should be informed about the importance of their psychological support I to their child by avoiding any punishment or embarrassment. Furthermore, the parents were asked to monitor their child's response by documenting the number of wet nights within the last 4 month. All children were then evaluated at the age of 5 and 5.5 years using the following outcomes through the last month before the visit: complete response (0 wet nights), > 80 % stoppage of bedwetting (< 6 wet nights), 50-80 % stoppage of bedwetting (6-15 wet nights) and < 50 % stoppage of bedwetting (> 15 wet nights).
Detailed description
A prospective randomized clinical study was conducted at Urology departments, faculties of medicine, Fayoum and Cairo Universities. All children either boys or girls between 4-4.5 years old presented with bedtime wetting despite good daytime urine control were included in the study. The children who were older than 4.5 years, had daytime voiding dysfunction, had behavioural disorders like attention deficient and hyperactivity disorder (ADHD) or other comorbidities like diabetes mellitus (DM) or congenital abnormalities were excluded from the study. In addition, those children whom parents refused to sign the consent of participation were also excluded. 120 children with primary monosymptomatic nocturnal enuresis (PMNE) were initially included in this study. They were randomized into two groups according to computer generated randomization. Group A (early therapy) included initially 60 child who had done behavioural and alarm therapy from the start of the study regularly till the age of 5.5 years and Group B (deferred therapy) included 60 child who waited without therapy till age of 5 years, then they started the behavioural and alarm therapy regularly for 6 months. They were interviewed at urology clinics in Fayoum and Cairo Universities in Egypt. The behavioural therapy was in the form of prompted and scheduled voiding, regular sleep timing, fluid and caffeine restriction and avoiding the cellular phones 2 hours before bedtime. If the child had constipation, it should be treated. In addition, alarm therapy was performed in the form of awaking the child every night by his parents after 1-2 hours from deep sleep to void then continue the sleep. The parents should be informed about the importance of their psychological support to their child by avoiding any punishment or embarrassment. Furthermore, the parents were asked to monitor their child's response by documenting the number of wet nights within the last 4 month. All children were then evaluated at the age of 5 and 5.5 years using the following outcomes through the last month before the visit: complete response (0 wet nights), > 80 % stoppage of bedwetting (< 6 wet nights), 50-80 % stoppage of bedwetting (6-15 wet nights) and < 50 % stoppage of bedwetting (> 15 wet nights).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| urotherapy | – | Behavioral: urotherapy |
| control | – | Behavioral: no intervention |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- PMNE
Key inclusion criteria (1 listed)
- PMNE
Key exclusion criteria (1 listed)
- neurogenic bladder
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 |
|---|---|---|
| urotherapyprompted and scheduled voiding, regular sleep timing, fluid and caffeine restriction and avoiding the cellular phones 2 hours before bedtime. If the child had constipation, it should be treated. In addition, alarm therapy was performed in the form of awaking the child every night by his parents after 1-2 hours from deep sleep to void then continue the sleep. The parents should be informed about the importance of their psychological support to their child by avoiding any punishment or embarrassment. Furthermore, the parents were asked to monitor their child's response by documenting the number of wet nights within the last month | Behavioural | urotherapy |
| no interventionno intervention | Behavioural | control |
Primary outcome
bed wetting
Time frame: 6 months
complete response (0 wet nights), > 80 % stoppage of bedwetting (< 6 wet nights), 50-80 % stoppage of bedwetting (6-15 wet nights) and < 50 % stoppage of bedwetting (> 15 wet nights).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
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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?
An observational study of Enuresis, Nocturnal, run by Cairo 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 1 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: finished, as of the sponsor's last update on 11 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
bed wetting (time frame: 6 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 11 Jun 2025.