The effect of screen time on nighttime urinary incontinence
| ISRCTN | ISRCTN15760867 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15760867 |
- Submission date
- 14/05/2022
- Registration date
- 23/05/2022
- Last edited
- 22/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Bladder and nighttime bed wetting (nocturnal enuresis) are common problems in children. The aim of this study is to investigate if there is a relationship between screen time and the severity of primary monosymptomatic (meaning patients who have never been consistently dry at night) nocturnal enuresis (PMNE) and treatment success.
Who can participate?
Children and adolescents aged from 6 to 18 years
What does the study involve?
Patients with PMNE are randomly allocated to one of two groups and both groups are given treatment. One group is requested to reduce daily screen time to less than 60 minutes and the other group is given unrestricted screen time.
What are the possible benefits and risks of participating
Participants are expected to benefit from reduced screen time by progressing in various developmental stages, including emotional, cognitive, behavioral, and sleep quality.
There are no known risks to participants.
Where is the study run from?
Afyonkarahisar Health Sciences University Hospital
When is the study starting and how long is it expected to run for?
February 2021 to October 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Arif Demirbas
demirbas-arif@hotmail.com
Contact information
Principal Investigator
Afyonkarahisar Health Sciences University
Department of Urology
Dörtyol 2070
Sokak NO:3/4
03030
Afyonkarahisar Merkez/Afyonkarahisar
03100
Türkiye
 ORCID ID |
0000-0003-4984-3722 |
|---|---|
| Phone | +90 532 250 00 72 |
| demirbas-arif@hotmail.com |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | The effect of screen time on the presentation and treatment of primary monosymptomatic nocturnal enuresis |
| Study acronym | SToPMNE |
| Study objectives | We aimed to investigate if there was any relationship between screen time and the severity of primary monosymptomatic nocturnal enuresis and treatment success |
| Ethics approval(s) | Approved 05/03/2021, Afyonkarahisar Health Sciences University Clinical Research Ethics Committee (Dörtyol, 2070. Sokak NO:3/4. 03030 Afyonkarahisar Merkez/Afyonkarahisar, Turkey; +90 272 246 33 01; klinikarastirmalar@afsu.edu.tr), ref: 2011-KAEK-2/198 |
| Health condition(s) or problem(s) studied | Primary monosymptomatic enuresis |
| Intervention | 1. After a diagnosis of primary monosymptomatic nocturnal enuresis, classified as mild (1-2 wet nights/week), moderate (3-5 wet nights/week) and severe (6-7 wet nights/week), patients were separated by the amount of screen time: Group 1. < 120 min mean screen time/day Group 2. > 120 min mean screen time/day 2. For treatment response, patients were randomly assigned to treatment: Group 3. Patients were administered 120 µg desmopressin melt (DeM) and, in addition to supportive treatment, were requested to reduce daily screen time to < 60 mins Group 4. Patients were given 120 µg DeM and supportive treatment was recommended with no restriction of screen time 3. Patients who reduced their screen time to less than 60 minutes were followed for 3 months. 4. Patients without recurrence, defined by one or more night-time bed wetting events in month 4, received further recommendations and terminated the trial. 5. Patients with recurrence were re-evaluated and treatment was planned. Treatment of other patients who did not benefit from treatment and behavioral adjustments continued. 6. The groups were statistically compared in respect of descriptive data, response to treatment, and recurrence. |
| Intervention type | Behavioural |
| Primary outcome measure | Treatment response measured by the dryness of a child’s sleeping quarters recorded daily on waking, defined as a full response at 100% dryness, a partial response at 50-99% dryness, or a failure at <50% dryness at month 3. Patients in groups 3 and 4 with a full response had their DeM treatment terminated and recurrence, defined by one or more night-time bed wetting events in month 4, was determined at a follow-up visit at the end of month 4. |
| Secondary outcome measures | Late recurrence, defined by one or more night-time bed wetting events from month 4 and measured daily on waking, was recorded at a 6-month long-term follow-up visit. |
| Overall study start date | 01/02/2021 |
| Completion date | 15/10/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 75 |
| Total final enrolment | 71 |
| Key inclusion criteria | 1. Aged 6 to 18 years 2. Diagnosed as primary monosymptomatic enuresis nocturna as a result of history, physical examination and routine tests 3. Have not had an operation due to urinary system pathologies before 4. A body mass index below the 95th percentile 5. Screen exposure of different durations 6. Caregivers or patients who can keep a voiding diary, nighttime bedwetting chart |
| Key exclusion criteria | 1. A diagnosis with secondary enuresis and non-monosymptomatic nocturnal enuresis 2. Previously treated for nocturnal enuresis 3. Neurological disease, obstructive respiratory diseases and diabetes mellitus 4. Previously diagnosed neurogenic bladder, vesicoureteral reflux, urinary system stone disease 5. Previous surgery due to urinary pathology 6. A body mass index above the 95th percentile 7. Caregivers or patients who cannot keep a voiding diary, nighttime bedwetting chart |
| Date of first enrolment | 15/03/2021 |
| Date of final enrolment | 15/06/2021 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Sokak No.3/4
A block
03030
Afyonkarahisar Merkez
Afyonkarahisar
03100
Türkiye
Sponsor information
University/education
Dörtyol 2070
Sokak NO:3/4
03030
Afyonkarahisar Merkez/Afyonkarahisar
03100
Türkiye
| Phone | +90 272 246 33 35 |
|---|---|
| bilgi@afsu.edu.tr | |
| Website | https://afsu.edu.tr/ |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/07/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer- reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study are/will be available upon reasonable request from Hacer Gizem Gerçek, gizem.gercek@afsu.edu.tr |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 17/02/2023 | 22/02/2023 | Yes | No |
Editorial Notes
22/02/2023: Publication reference added.
20/05/2022: Trial's existence was confirmed by Afyonkarahisar Health Sciences University Clinical Research Ethics Committee.
