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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04300400
Other study ID # B670201835542
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 16, 2018
Est. completion date September 10, 2019

Study information

Verified date January 2023
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date September 10, 2019
Est. primary completion date July 23, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Profession: MD, Urologist - Member of the working group of Functional Urology Exclusion Criteria: - Retirement - Non-operative as an urologist.

Study Design


Intervention

Other:
Delphi questionnaire
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.

Locations

Country Name City State
Belgium University Hospital Ghent Ghent East-Flanders

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Ghent Astellas Pharma Inc, Medtronic

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Degree of consensus on the level of appropriateness No consensus, trend towards consensus or consensus 8 months
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