Overactive Bladder SyndromeNCT04300400
Treatment of the Overactive Bladder Syndrome: A Delphi Study
An observational study of Overactive Bladder Syndrome, run by University Hospital, Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Overactive Bladder Syndrome
- What is being tested?
- Delphi questionnaire
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Oct 2018to 10 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Belgian Urologists: members of the working group of Functional Urology.
Who may be able to join
- Profession: MD, Urologist
- Member of the working group of Functional Urology
Who cannot join
- Retirement
- Non-operative as an urologist.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Flowchart Reflecting the Current Attitude and Approach Towards the Idiopathic Overactive Bladder Treatment in Belgium: A Delphi Study
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.
Read the 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.
- Conditions
- Overactive Bladder Syndrome
- Being tested
- Delphi questionnaire
- Keywords
- Overactive bladder Syndrome, Delphi study, Treatment algorithm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delphi questionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Delphi panel | Urologists of the Belgian Working group of Functional Urology willing to participate on the Delphi project. Receives: Other: Delphi questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of consensus on the level of appropriateness
No consensus, trend towards consensus or consensus
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start16 Oct 2018
- Primary completion23 Jul 2019
- Study completion10 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc, Medtronic
- Responsible party
- Sponsor
- Investigators
- Lynn Ghijselings, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300400
- Sponsor's protocol ID
- B670201835542
- Status last verified
- Jan 2023
- First submitted
- 7 Feb 2020
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Flowchart Reflecting the Current Attitude and Approach Towards the Idiopathic Overactive Bladder Treatment in Belgium: A Delphi Study
- ClinicalTrials.gov ID
- NCT04300400
- Acronym / sponsor ID
- B670201835542
- Conditions
- Overactive Bladder Syndrome
- Keywords
- Overactive bladder Syndrome, Delphi study, Treatment algorithm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc, Medtronic
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 23 Jul 2019 (actual)
- Study completion
- 10 Sep 2019 (actual)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Delphi panel | – | Other: Delphi questionnaireUrologists of the Belgian Working group of Functional Urology willing to participate on the Delphi project. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Belgian Urologists: members of the working group of Functional Urology.
Key inclusion criteria (2 listed)
- Profession: MD, Urologist
- Member of the working group of Functional Urology
Key exclusion criteria (2 listed)
- Retirement
- Non-operative as an urologist.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delphi questionnaireStatements 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. | Other | Delphi panel |
Primary outcome
Degree of consensus on the level of appropriateness
Time frame: 8 months
No consensus, trend towards consensus or consensus
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynn Ghijselings, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder Syndrome, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of consensus on the level of appropriateness (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.