The Relationship Between Nocturnal Enuresis And Spina Bifida Occulta

Spina Bifida Clinical Trial

Official title:

The Relationship Between Nocturnal Enuresis And Spina Bifida Occulta: A Prospective Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03543995
• Other study ID #: 5520
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: May 15, 2018

Study information

• Verified date: May 2018
• Source: Ankara Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: May 15, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Enuresis, Nocturnal
• Nocturnal Enuresis
• Spina Bifida
• Spinal Dysraphism
• Urinary Incontinence

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Training and Research Hospital

References & Publications (3)

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):2 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months