Overactive Bladder (OAB)NCT03903094
A Study on Anticholinergic Use: Attribution of Overactive Bladder (OAB) Medications to the Anticholinergic Burden
An observational study of Overactive Bladder (OAB), run by Astellas Pharma Singapore Pte. Ltd. at 2 sites in 2 countries.
Trial summary
Outpatients with at least one dispensing record of any medication will be included in the study. An index date will be assigned to each participant and prescription records for anticholinergics will be used in the study. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Overactive Bladder (OAB)
- What is being tested?
- Non-Interventional
- How many people
- 6,295,279 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 Mar 2019to 6 May 2022
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Australian and Korean with at least one prescription of any treatment between January 22, 2016 (For Korea: January 1st, 2016) and December 31, 2016 derived from country claims data.
Who may be able to join
- Have at least one dispensing of any medication between January 22, 2016 and December 31, 2016.
- Have at least one dispensing of any medication between January 1st, 2016 and December 31, 2016.
- Participant was diagnosed with OAB (ICD-10 N32.8, N31.0, N31.1, N31.2, N31.8, N31.9, N32.9, N39.8 and N39.40) at index date.
- Participant did not have dispensing record of an OAB medication during the washout period (6 months prior to the index date).
Who cannot join
- Participants who do not have a complete year of data availability in the database prior to index date.
- Have record of hospitalization on the index date.
- Participant was hospitalized on the index date.
- Participant did not have an active insurance status during the washout period or on the index date.
- Participant received onabotulinumtoxin A and/or surgical intervention as part of the OAB treatment during the washout period.
- Participant was diagnosed with stress incontinence (ICD-10 N39.3 or equivalent) or had dispensing record of medication for stress incontinence (duloxetine) during the washout period.
- Participant was diagnosed with urinary tract infection (ICD-10 N30.0 and N39.0 or equivalent) during the washout period or on the index date.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Retrospective Database Analysis of Anticholinergic Burden Among the Elderly With and Without Overactive Bladder in Australia and South Korea
Outpatients with at least one dispensing record of any medication will be included in the study. An index date will be assigned to each participant and prescription records for anticholinergics will be used in the study.
- Conditions
- Overactive Bladder (OAB)
- Being tested
- Non-Interventional
- Keywords
- anticholinergic burden, anticholinergic, overactive bladder
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
Overview of anticholinergic burden, rather than to evaluate specific drugs
| Study group | Role | What they receive |
|---|---|---|
| Subjects With Overactive Bladder Treatment | Subjects who have dispensing records for treatment of overactive bladder will be included Receives: Other: Non-Interventional | |
| Subjects Without Overactive Bladder Treatment | Subjects who do not have dispensing records for treatment of overactive bladder will be included Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anticholinergic Cognitive Burden (ACB) score
ACB will be calculated based on methodology from Campbell et al (2016). Sum (Drug A #days prescribed X ACB scale score) + (Drug B #days prescribed X ACB scale score) + (Drug X…)/Number of days with any medication prescribed. The cumulative score has a range from 0 to infinity, with higher values indicating a higher cumulative anticholinergic burden of the patient.
Measured: 100 days
Korea Specific: Percentage of Participants With any Listed Anticholinergic Use
This will be calculated as number of participants with any listed anticholinergics use divided by number of participants fulfilling the general eligibility criteria of the study (in each study dataset) multiplied by 100.
Measured: 100 days
Korea Specific: Percentage of Participants With Strong Anticholinergic Use
This will be calculated as number of participants with strong anticholinergics use divided by number of participants fulfilling the general eligibility criteria of the study (in each study dataset) multiplied by 100.
Measured: 100 days
Korea Specific: Number of Anticholinergics Dispensed per Participants
This will be calculated as total number of anticholinergics dispensed divided by number of participants fulfilling the general eligibility criteria of the study (in each study dataset) multiplied by 100.
Measured: 100 days
Korea Specific: Attribution Proportion of OAB medications to total ACB in OAB Cohort
Attribution proportion of OAB medication to total ACB will be calculated as the ratio between the sum over all OAB patients of the ACB scores of each OAB medication multiplied by the number of days supply in the numerator and the sum over all OAB patients of the ACB scores of each antimuscarinic medication multiplied by the number of days supply in the denominator.
Measured: 100 days
Secondary outcomes (1)
Median percentage of ACB score derived from overactive bladder (OAB) treatment(s) in total ACB score
The attribution of antimuscarinics for OAB treatment to entire anticholinergic exposures in OAB patients.
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start7 Mar 2019
- Primary completion6 May 2022
- Study completion6 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder (OAB)Studies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 6,295,279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Singapore Pte. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903094
- Sponsor's protocol ID
- 178-MA-3241
- Status last verified
- Oct 2024
- First submitted
- 25 Mar 2019
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Database Analysis of Anticholinergic Burden Among the Elderly With and Without Overactive Bladder in Australia and South Korea
- ClinicalTrials.gov ID
- NCT03903094
- Acronym / sponsor ID
- 178-MA-3241
- Conditions
- Overactive Bladder (OAB)
- Keywords
- anticholinergic burden, anticholinergic, overactive bladder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,295,279 participants (actual)
- Lead sponsor
- Astellas Pharma Singapore Pte. Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 6 May 2022 (actual)
- Study completion
- 6 May 2022 (actual)
- First posted
- 4 Apr 2019 (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.
Outpatients with at least one dispensing record of any medication will be included in the study. An index date will be assigned to each participant and prescription records for anticholinergics will be used in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects With Overactive Bladder Treatment | – | Other: Non-InterventionalSubjects who have dispensing records for treatment of overactive bladder will be included |
| Subjects Without Overactive Bladder Treatment | – | Other: Non-InterventionalSubjects who do not have dispensing records for treatment of overactive bladder will be included |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Australian and Korean with at least one prescription of any treatment between January 22, 2016 (For Korea: January 1st, 2016) and December 31, 2016 derived from country claims data.
Key inclusion criteria (4 listed)
- Have at least one dispensing of any medication between January 22, 2016 and December 31, 2016.
- Have at least one dispensing of any medication between January 1st, 2016 and December 31, 2016.
- Participant was diagnosed with OAB (ICD-10 N32.8, N31.0, N31.1, N31.2, N31.8, N31.9, N32.9, N39.8 and N39.40) at index date.
- Participant did not have dispensing record of an OAB medication during the washout period (6 months prior to the index date).
Key exclusion criteria (7 listed)
- Participants who do not have a complete year of data availability in the database prior to index date.
- Have record of hospitalization on the index date.
- Participant was hospitalized on the index date.
- Participant did not have an active insurance status during the washout period or on the index date.
- Participant received onabotulinumtoxin A and/or surgical intervention as part of the OAB treatment during the washout period.
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 |
|---|---|---|
| Non-InterventionalOverview of anticholinergic burden, rather than to evaluate specific drugs | Other | Subjects With Overactive Bladder Treatment, Subjects Without Overactive Bladder Treatment |
Primary outcome
Anticholinergic Cognitive Burden (ACB) score
Time frame: 100 days
ACB will be calculated based on methodology from Campbell et al (2016). Sum (Drug A #days prescribed X ACB scale score) + (Drug B #days prescribed X ACB scale score) + (Drug X…)/Number of days with any medication prescribed. The cumulative score has a range from 0 to infinity, with higher values indicating a higher cumulative anticholinergic burden of the patient.
Korea Specific: Percentage of Participants With any Listed Anticholinergic Use
Time frame: 100 days
This will be calculated as number of participants with any listed anticholinergics use divided by number of participants fulfilling the general eligibility criteria of the study (in each study dataset) multiplied by 100.
Korea Specific: Percentage of Participants With Strong Anticholinergic Use
Time frame: 100 days
This will be calculated as number of participants with strong anticholinergics use divided by number of participants fulfilling the general eligibility criteria of the study (in each study dataset) multiplied by 100.
Korea Specific: Number of Anticholinergics Dispensed per Participants
Time frame: 100 days
This will be calculated as total number of anticholinergics dispensed divided by number of participants fulfilling the general eligibility criteria of the study (in each study dataset) multiplied by 100.
Korea Specific: Attribution Proportion of OAB medications to total ACB in OAB Cohort
Time frame: 100 days
Attribution proportion of OAB medication to total ACB will be calculated as the ratio between the sum over all OAB patients of the ACB scores of each OAB medication multiplied by the number of days supply in the numerator and the sum over all OAB patients of the ACB scores of each antimuscarinic medication multiplied by the number of days supply in the denominator.
1 secondary outcome
Median percentage of ACB score derived from overactive bladder (OAB) treatment(s) in total ACB score
Time frame: 100 days
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 31 Oct 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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RELIEVE Study: NT 201 Intravesical Administration Using Vibe System (ViXe Combination Product) for the Treatment of Idiopathic Overactive Bladder
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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.
Central Contact study director
Astellas Pharma Global Development, Inc.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder (OAB), run by Astellas Pharma Singapore Pte. Ltd. at 2 sites in 2 countries.
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 4 inclusion and 7 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 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, South Korea. 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?
Anticholinergic Cognitive Burden (ACB) score (time frame: 100 days). The study lists 5 primary outcomes in all. 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 31 Oct 2024; AzTrials last refreshed its copy on 1 Nov 2026.