Treatment of the Overactive Bladder Syndrome: A Delphi Study | NCT04300400

Studies
Treatment of the Overactive Bladder Syndrome: A Delphi Study

NCT04300400

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Jan 19, 2023Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Overactive Bladder Syndrome

Interventions

Delphi questionnaire

Countries

Belgium

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

Jan 2023

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

Oct 16, 2018Actual

Primary Completion Date

Jul 23, 2019Actual

Completion Date

Sep 10, 2019Actual

First Submitted Date

Feb 7, 2020

First Submission Date that Met QC Criteria

Mar 5, 2020

First Posted Date

Mar 9, 2020Actual

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

Jan 17, 2023

Last Update Posted Date

Jan 19, 2023Actual

Name	Class
Astellas Pharma Inc	INDUSTRY
Medtronic	INDUSTRY

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Idiopathic overactive bladder syndrome (iOAB) is a prevalent condition in urological practice. The variability in management between specialists and between centers remains high. Even guidelines are not always clear on the treatment management of drug therapy resistant OAB. Standardization in OAB treatment is needed.

Detailed Description

Guidelines on the overactive bladder syndrome (European Association of Urology, American Urology Association and International Consultation on Incontinence) are comparable but remain vague mainly on the level between conservative and major surgery. They do not specify combinations of medications and do not distinguish between intradetrusor botulinum toxin injections (BTX) and sacral neuromodulation (SNM) because of lack of evidence.

To reduce the variability in the treatment management of OAB, standardization is needed.

By use of a Delphi technique, the current perception of Belgian urologists towards the most appropriate treatment approach for idiopathic OAB (iOAB) was explored.

Based on these results a practical treatment algorithm for its use in daily clinical practice could be developed.

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Delphi panel		Urologists of the Belgian Working group of Functional Urology willing to participate on the Delphi project.	Other: Delphi questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Delphi questionnaire	Other	Statements on OAB topics, rated along their level of appropriateness on a scale from 1 to 9. Multiple rounds are organised to reach consensus on a topic.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Degree of consensus on the level of appropriateness	No consensus, trend towards consensus or consensus	8 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Profession: MD, Urologist
Member of the working group of Functional Urology

Exclusion Criteria:

Retirement
Non-operative as an urologist.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Belgian Urologists: members of the working group of Functional Urology.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lynn Ghijselings, MD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Ghent		Ghent	East-Flanders	9000	Belgium

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