The Relationship Between Nocturnal Enuresis And Spina Bifida Occulta

NCT ID: NCT03543995

Last Updated: 2018-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

330 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-05-15

Brief Summary

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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.

Detailed Description

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Conditions

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Enuresis, Nocturnal Spina Bifida

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Enuresis nocturna

Patients aged 6 to 15 years with at least one night-time wetting weekly

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients aged 6 to 15 years
* at least one night-time wetting weekly

Exclusion Criteria

* neurological disease,
* diabetes mellitus or insipidus,
* spinal surgery history, spina bifida skin findings,
* chronic renal insufficiency
* and secondary enuresis
Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Muhammet Fatih Kilinc

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type RESULT
PMID: 26149636 (View on PubMed)

Cakiroglu 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.

Reference Type RESULT
PMID: 25641449 (View on PubMed)

Miyazato 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.

Reference Type RESULT
PMID: 17199857 (View on PubMed)

Other Identifiers

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5520

Identifier Type: -

Identifier Source: org_study_id

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