Overactive Bladder Syndrome | NCT05151081

Studies
Overactive Bladder Syndrome

NCT05151081

Sponsor

Hisar Intercontinental Hospital

Status

Completed

Last Update Posted

Dec 9, 2021Actual

Enrollment

87Actual

Phase

Not provided

Conditions

Overactive Bladder Syndrome
Enuresis, Nocturnal

Interventions

basicly

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 3, 2020Actual

Primary Completion Date

Jul 3, 2021Actual

Completion Date

Oct 15, 2021Actual

First Submitted Date

Nov 11, 2021

First Submission Date that Met QC Criteria

Nov 25, 2021

First Posted Date

Dec 9, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2021

Last Update Posted Date

Dec 9, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Basri Cakiroglu, Ass. Prof., Hisar Intercontinental HospitalPrincipal Investigator

Lead Sponsor

Hisar Intercontinental HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

87Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Enuresis, Non-Enuresis		Patients were divided into two gruops according to whether having NE or not during childhood	Other: basicly

Interventions

Name	Type	Description	Arm Group Labels	Other Names
basicly	Other	Do not repeat information already included in arm/group descriptions.	Enuresis, Non-Enuresis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

overactive bladder syndrome
enuresis nocturna

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

up to 18 year and all sex

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Basri Cakiroglu	Hisar Intercontinental Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hisar Intercontinental Hospital		Istanbul		34768	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D053206	Nocturnal Enuresis
D053201	Urinary Bladder, Overactive

Ancestor Terms

ID	Term
D004775	Enuresis
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

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Browse Branches

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