NCT05151081

Brief Summary

Purpose: A lot of etiological factors related to overactive bladder (OAB) has been investigated. However, the role of primary nocturnal enuresis (NE), which is characterized with childhood night time incontinence, in the etiology of OAB is controversial. This study aims to evaluate the effect of NE in patients diagnosed with OAB. Metod Between january-september 2021, the data of patients who applied to the urology outpatientclinic with OAB symptoms were collected. Patients with a history of chronic systemic disease, previous medical treatment for OAB and who did not accept to join the study were excluded. According to the diagnosis of childhood NE, patients were divided into two groups. Demographic data hav been recorded. Frequency of incontinence, number of day time void and nocturia were evaluated according to a 3 day voiding diary. Inaddition, max. Urinary flowr atio (Qmax), bladder Wall thickness and postvoid residual volüme rates were determined using uroflowmetry and pelvic ultrasound.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

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

February 3, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2021

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
Last Updated

December 9, 2021

Status Verified

November 1, 2021

Enrollment Period

1.4 years

First QC Date

November 11, 2021

Last Update Submit

November 25, 2021

Conditions

Keywords

Overactive bladderEnuresis nocturnatreatmentetiology

Outcome Measures

Primary Outcomes (1)

  • A diagnose of childhood NE in OAB patients can cause more severe semptomatologic progression

    This study aims to evaluate the effect of NE in patients diagnosed with OAB.Definition of NE is urinary incontinence in children over the age of 5 during sleep ,as defined by International Children's Continence Society. Overactive Bladder Symptom Score (OABSS) questionnaire were used for the assessment of OAB. OABSS is an questionnaire ,consisting of 4 questions, was prepared by Homma et al. in 2006

    1 years

Study Arms (1)

Enuresis, Non-Enuresis

Patients were divided into two gruops according to whether having NE or not during childhood

Other: basicly

Interventions

basiclyOTHER

Do not repeat information already included in arm/group descriptions.

Enuresis, Non-Enuresis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

up to 18 year and all sex

You may qualify if:

  • overactive bladder syndrome
  • enuresis nocturna

You may not qualify if:

  • diabetes mellitus,
  • neurological diseases
  • bladder outlet obstruction,
  • active urinary system infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hisar Intercontinental Hospital

Istanbul, 34768, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Nocturnal EnuresisUrinary Bladder, Overactive

Condition Hierarchy (Ancestors)

EnuresisUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBehavioral SymptomsBehaviorElimination DisordersMental DisordersUrinary Bladder DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Basri Cakiroglu

    Hisar Intercontinental Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof.

Study Record Dates

First Submitted

November 11, 2021

First Posted

December 9, 2021

Study Start

February 3, 2020

Primary Completion

July 3, 2021

Study Completion

October 15, 2021

Last Updated

December 9, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations