NCT03543995

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 1, 2018

Completed
Last Updated

June 1, 2018

Status Verified

May 1, 2018

Enrollment Period

12 months

First QC Date

May 22, 2018

Last Update Submit

May 31, 2018

Conditions

Keywords

lower urinary tract symptomsnocturnal enuresisspina bifida occultatreatment response

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Nocturnal EnuresisSpinal DysraphismLower Urinary Tract SymptomsSpina Bifida Occulta

Condition Hierarchy (Ancestors)

EnuresisUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBehavioral SymptomsBehaviorElimination DisordersMental DisordersNeural Tube DefectsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 22, 2018

First Posted

June 1, 2018

Study Start

January 1, 2017

Primary Completion

December 31, 2017

Study Completion

May 15, 2018

Last Updated

June 1, 2018

Record last verified: 2018-05