Enuresis, NocturnalNCT03543995
The Relationship Between Nocturnal Enuresis And Spina Bifida Occulta
An observational study of Enuresis, Nocturnal and Spina Bifida, run by Ankara Training and Research Hospital.
Trial summary
It is claimed that SBO may be responsible for bladder dysfunction in patients without known neurological disease. Subsequently, it was reported that the frequency of SBO in NE cases was higher than normal children. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Enuresis, Nocturnal, Spina Bifida
- How many people
- 330 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 15 May 2018
- How long will I take part?
- 3 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 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients aged 6 to 15 years who were admitted to an urology outpatient clinics with at least one night-time wetting weekly, were included in this prospective study. The control group consisted of patients who were admitted to the urology outpatient clinic with a complaint of abdominal or lateral pain, who had no NE and had a direct abdominal x-ray examination. The patients who were selected as the control group had night wetness questioned and the dysfunctional voiding symptom score (DVSS) form was completed. Those who had night wetting, neurological disease or diabetes mellitus were not included in the control group.
Who may be able to join
- Patients aged 6 to 15 years
- at least one night-time wetting weekly
Who cannot join
- neurological disease,
- diabetes mellitus or insipidus,
- spinal surgery history, spina bifida skin findings,
- chronic renal insufficiency
- and secondary enuresis
About this study
Official title: The Relationship Between Nocturnal Enuresis And Spina Bifida Occulta: A Prospective Controlled Trial
It is claimed that SBO may be responsible for bladder dysfunction in patients without known neurological disease. Subsequently, it was reported that the frequency of SBO in NE cases was higher than normal children. However, in controlled trials, SBO frequency was not different in NE patients compared to the normal population. Conversely, the incidence of dysfunctional bladder in the presence of SBO in NE patients was found to be higher and the response to treatment was worse than in non-SBO patients.
The present study aimed to determine whether the frequency of SBO in patients with NE was higher than in healthy subjects, the effect of SBO on the severity of LUTS and whether treatment response of primary NE patients changed in the presence of SBO.
- Conditions
- Enuresis, Nocturnal, Spina Bifida
- Keywords
- lower urinary tract symptoms, nocturnal enuresis, spina bifida occulta, treatment response
- Medical subject headings
- Nocturnal Enuresis, Spinal Dysraphism, Lower Urinary Tract Symptoms, Spina Bifida Occulta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Enuresis nocturna | Patients aged 6 to 15 years with at least one night-time wetting weekly | |
| Normal population | Patients who were admitted to the urology clinic with a complaint of abdominal or lateral pain, who had no NE and had a direct abdominal x-ray examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dry bed days
Patients were called for check-up one and three months later. When waking in the morning they were given a form to mark as dry or wet, and dry bed days were examined at check-up.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start1 Jan 2017
- Primary completion31 Dec 2017
- Study completion15 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Enuresis, NocturnalStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 330 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammet Fatih Kilinc, Ankara Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543995
- Sponsor's protocol ID
- 5520
- Status last verified
- May 2018
- First submitted
- 22 May 2018
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kurt O, Yazici CM, Paketci C. Nocturnal enuresis with spina bifida occulta: Does it interfere behavioral management success? Int Urol Nephrol. 2015 Sep;47(9):1485-91. doi: 10.1007/s11255-015-1047-4. Epub 2015 Jul 7.
PubMed 26149636Cakiroglu B, Tas T, Eyyupoglu SE, Hazar AI, Can Balci MB, Nas Y, Yilmazer F, Aksoy SH. The adverse influence of spina bifida occulta on the medical treatment outcome of primary monosymptomatic nocturnal enuresis. Arch Ital Urol Androl. 2014 Dec 30;86(4):270-3. doi: 10.4081/aiua.2014.4.270.
PubMed 25641449Miyazato M, Sugaya K, Nishijima S, Owan T, Ogawa Y. Location of spina bifida occulta and ultrasonographic bladder abnormalities predict the outcome of treatment for primary nocturnal enuresis in children. Int J Urol. 2007 Jan;14(1):33-8. doi: 10.1111/j.1442-2042.2006.01666.x.
PubMed 17199857
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Nocturnal Enuresis And Spina Bifida Occulta: A Prospective Controlled Trial
- ClinicalTrials.gov ID
- NCT03543995
- Acronym / sponsor ID
- 5520
- Conditions
- Enuresis, Nocturnal, Spina Bifida
- Keywords
- lower urinary tract symptoms, nocturnal enuresis, spina bifida occulta, treatment response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 15 May 2018 (actual)
- First posted
- 1 Jun 2018 (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.
It is claimed that SBO may be responsible for bladder dysfunction in patients without known neurological disease. Subsequently, it was reported that the frequency of SBO in NE cases was higher than normal children. However, in controlled trials, SBO frequency was not different in NE patients compared to the normal population. Conversely, the incidence of dysfunctional bladder in the presence of SBO in NE patients was found to be higher and the response to treatment was worse than in non-SBO patients.
The present study aimed to determine whether the frequency of SBO in patients with NE was higher than in healthy subjects, the effect of SBO on the severity of LUTS and whether treatment response of primary NE patients changed in the presence of SBO.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enuresis nocturna | – | –Patients aged 6 to 15 years with at least one night-time wetting weekly |
| Normal population | – | –Patients who were admitted to the urology clinic with a complaint of abdominal or lateral pain, who had no NE and had a direct abdominal x-ray examination |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients aged 6 to 15 years who were admitted to an urology outpatient clinics with at least one night-time wetting weekly, were included in this prospective study. The control group consisted of patients who were admitted to the urology outpatient clinic with a complaint of abdominal or lateral pain, who had no NE and had a direct abdominal x-ray examination. The patients who were selected as the control group had night wetness questioned and the dysfunctional voiding symptom score (DVSS) form was completed. Those who had night wetting, neurological disease or diabetes mellitus were not included in the control group.
Key inclusion criteria (2 listed)
- Patients aged 6 to 15 years
- at least one night-time wetting weekly
Key exclusion criteria (5 listed)
- neurological disease,
- diabetes mellitus or insipidus,
- spinal surgery history, spina bifida skin findings,
- chronic renal insufficiency
- and secondary enuresis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dry bed days
Time frame: 3 months
Patients were called for check-up one and three months later. When waking in the morning they were given a form to mark as dry or wet, and dry bed days were examined at check-up.
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 1 Jun 2018.
- Results publication: PubMed 26149636Kurt O, Yazici CM, Paketci C. Nocturnal enuresis with spina bifida occulta: Does it interfere behavioral management success? Int Urol Nephrol. 2015 Sep;47(9):1485-91. doi: 10.1007/s11255-015-1047-4. Epub 2015 Jul 7.
- Results publication: PubMed 25641449Cakiroglu B, Tas T, Eyyupoglu SE, Hazar AI, Can Balci MB, Nas Y, Yilmazer F, Aksoy SH. The adverse influence of spina bifida occulta on the medical treatment outcome of primary monosymptomatic nocturnal enuresis. Arch Ital Urol Androl. 2014 Dec 30;86(4):270-3. doi: 10.4081/aiua.2014.4.270.
- Results publication: PubMed 17199857Miyazato M, Sugaya K, Nishijima S, Owan T, Ogawa Y. Location of spina bifida occulta and ultrasonographic bladder abnormalities predict the outcome of treatment for primary nocturnal enuresis in children. Int J Urol. 2007 Jan;14(1):33-8. doi: 10.1111/j.1442-2042.2006.01666.x.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Enuresis, Nocturnal and Spina Bifida, run by Ankara Training and Research Hospital.
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 2 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: finished, as of the sponsor's last update on 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Dry bed days (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03543995, which also lists 3 linked publications.
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 1 Jun 2018.