EnuresisNCT05190601
Uroflowmetry in Children With Enuresis Nocturnal
An observational study of Enuresis, run by Hisar Intercontinental Hospital at 1 site in Turkey (Türkiye).
Trial summary
Background: Enuresis nocturna is an important social and psychological problem in children. Uroflowmetry is an important test used to investigate lower urinary tract symptoms.. Objective:To evaluate the uroflowmetry (UFM) results of children with nocturnal enuresis (NE). Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Enuresis
- What is being tested?
- uroflowmetry
- Type of treatment
- Medical device
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 11 Dec 2021
- How long will I take part?
- 18 Months
- 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 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pediatric,primary monosymptomatic enuresis nocturna, 6-16 years, without comorbidity
Who may be able to join
- Primer monosymptomatic enuresis nocturna
Who cannot join
- Urinary infectious Diabetes Spina bifida, Epispadias, Hipospadias VUR Extrophia Vesica Epilepsy Cerebral Palsy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hisar Intercontinental Hospital
Istanbul, 34768
About this study
Official title: How Valuable is Uroflowmetry in Children With Enuresis Nocturnal?
Background: Enuresis nocturna is an important social and psychological problem in children. Uroflowmetry is an important test used to investigate lower urinary tract symptoms..
Objective:To evaluate the uroflowmetry (UFM) results of children with nocturnal enuresis (NE).
Read more
Method:
The uroflowmetry findings of healthy and visualized children without any urinary symptoms and who were prospectively admitted to the urology and pediatric surgery outpatient clinic with the complaint of Enuresis nocturna between January 2020 and July 2021 were compared. Information (anamnesis, physical examination, radiology results and laboratory tests) and uroflowmetry results of NE and healthy children included in the study were recorded.
Read the detailed description
SMale and Female,
- Conditions
- Enuresis
- Being tested
- uroflowmetry
- Keywords
- enuresis nocturna, uroflowmetry, child
- Medical subject headings
- Enuresis, Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uroflowmetryDevice
Qmax(ml/s),Qav(ml/s),Volume (ml)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Enuresis nocturna with children Receives: Device: uroflowmetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
uroflowmetry
ml/s
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start1 Jan 2020
- Primary completion30 Jul 2021
- Study completion11 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Hisar Intercontinental Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basri Cakiroglu, Hisar Intercontinental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190601
- Sponsor's protocol ID
- 14.102021/1600
- Status last verified
- Dec 2021
- First submitted
- 11 Dec 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Valuable is Uroflowmetry in Children With Enuresis Nocturnal?
- ClinicalTrials.gov ID
- NCT05190601
- Acronym / sponsor ID
- 14.102021/1600
- Conditions
- Enuresis
- Keywords
- enuresis nocturna, uroflowmetry, child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Hisar Intercontinental HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 11 Dec 2021 (actual)
- First posted
- 13 Jan 2022 (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.
Background: Enuresis nocturna is an important social and psychological problem in children. Uroflowmetry is an important test used to investigate lower urinary tract symptoms..
Objective:To evaluate the uroflowmetry (UFM) results of children with nocturnal enuresis (NE).
Method:
The uroflowmetry findings of healthy and visualized children without any urinary symptoms and who were prospectively admitted to the urology and pediatric surgery outpatient clinic with the complaint of Enuresis nocturna between January 2020 and July 2021 were compared. Information (anamnesis, physical examination, radiology results and laboratory tests) and uroflowmetry results of NE and healthy children included in the study were recorded.
Detailed description
SMale and Female,
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: uroflowmetryEnuresis nocturna with children |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pediatric,primary monosymptomatic enuresis nocturna, 6-16 years, without comorbidity
Key inclusion criteria (1 listed)
- Primer monosymptomatic enuresis nocturna
Key exclusion criteria (1 listed)
- Urinary infectious Diabetes Spina bifida, Epispadias, Hipospadias VUR Extrophia Vesica Epilepsy Cerebral Palsy
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 |
|---|---|---|
| uroflowmetryQmax(ml/s),Qav(ml/s),Volume (ml) | Device | Group 1 |
Primary outcome
uroflowmetry
Time frame: 2 years
ml/s
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 13 Jan 2022.
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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, run by Hisar Intercontinental Hospital at 1 site in Turkey (Türkiye).
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 13 Jan 2022. 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 Turkey (Türkiye). 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?
uroflowmetry (time frame: 2 years). 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 13 Jan 2022.