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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05151081
Other study ID # 2020/04
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 3, 2020
Est. completion date October 15, 2021

Study information

Verified date November 2021
Source Hisar Intercontinental Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

A prospective randomized study is a study based on basic urological data. This study aims to evaluate the effect of NE in patients diagnosed with OAB.


Recruitment information / eligibility

Status Completed
Enrollment 87
Est. completion date October 15, 2021
Est. primary completion date July 3, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - overactive bladder syndrome - enuresis nocturna Exclusion Criteria: - diabetes mellitus, - neurological diseases - bladder outlet obstruction, - active urinary system infection

Study Design


Intervention

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

Locations

Country Name City State
Turkey Hisar Intercontinental Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Hisar Intercontinental Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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