Overactive Bladder SyndromeNCT03536494
Effectiveness of a Structured Intervention to Optimize the Use of Mirabegron
A study testing Review the use of mirabegron and its discontinuation in people with Overactive Bladder Syndrome, run by Catalan Institute of Health.
Trial summary
This study was a multicentre, quasi-experimental design, controlled, before-and-after trial to estimate the effectiveness related to the review of mirabegron use and, if appropriate, its discontinuation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder Syndrome
- What is being tested?
- Review the use of mirabegron and its discontinuation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,932 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2017
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years with mirabegron prescription. The prescription could be performed by a hospital or primary care doctor.
Who cannot join
- Patients under 18 years
About this study
Official title: Effectiveness of a Structured Intervention to Optimize Both the Use of Mirabegron, a β3 Receptor Agonist, and Facilitate Its Discontinuation: a Quasi-experimental Study
This study was a multicentre, quasi-experimental design, controlled, before-and-after trial to estimate the effectiveness related to the review of mirabegron use and, if appropriate, its discontinuation.
Intervention group: Patients with mirabegron prescription assigned to any of the 17 primary health care centers (PHC) located in the northern area of Barcelona.
Read more
Control group: All the other patients assigned to any of the other 34 health care centers in Barcelona belonging to the Catalan Institut of Health (CIH).
The structured intervention included initiatives with general practitioners and urologists/gynaecologists, management support from health care authorities, and monthly feed-back monitoring to general practitioners (GPs).
The follow-up period was 12 months, from January 1st to December 31st, 2017.
Read the detailed description
A quasi-experimental design with before/after measurement and a control group was used.
The objective was to identify the effectiveness of a training activity on the review of treatments. In addition, it was proposed to establish the duration of medication in real clinical practice, and its prevalence of use before and after the intervention.
Control group: Usual care
Intervention:
- Initiatives for healthcare professionals: information and training with written material, in an diagram format, distributed to all general practitioners.
- Initiatives for specialized hospital care: information regarding the intervention for urologists and gynaecologists.
- Management support with the definition of a structured strategy for all the addresses of the PHC and GPs.
- Monthly monitoring of the intervention (feed-back to all GPs).
The intervention consisted of: a) meetings with all the directors of the PHC; b) informative meetings and sessions in the PHC; c) distribution of the diagram to all the GPs; d) lists of patients with treatment provided periodically from the medication area; and e) review of the treatments by the GPs.
If considered appropriate, and with the consent of the patient, the medication was withdrawn.
A pharmacist and a clinical pharmacologist acted as consultants in case of any doubts regarding specific patients.
- Conditions
- Overactive Bladder Syndrome
- Being tested
- Review the use of mirabegron and its discontinuation
- Keywords
- Overactive bladder, Mirabegron, Persistence, Patient-Centered Care, Inappropriate prescribing, Discontinuation
- 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.
Review the use of mirabegron and its discontinuationBehavioural
A structured intervention was designed consisting of four major sections:
- General practitioners: information and training with written material and patient-centred prescribing.
- Specialized hospital care: information regarding the intervention for urologists and gynaecologists.
- Management support with the definition of a structured strategy.
- Monthly monitoring of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Mirabegron intervention | Experimental | Review the use of mirabegron and its discontinuation Receives: Behavioral: Review the use of mirabegron and its discontinuation |
| Control group | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of the number of participants with treatment
The percentage of change from baseline of the number of participants with treatment at 3, 6, 9 and 12 months with respect to basal values (day 0)
Measured: Data will be collected prospectively at five points in time: Day 0; Month 3 after inclusion; Month 6 after inclusion; Month 9 after inclusion; Month 12 after inclusion
Secondary outcomes (2)
Change from baseline of the duration of treatment at 3, 6, 9, and 12 months with respect to basal values (day 0)
Time from treatment commencement to discontinuation in real clinical practice
Measured: Data will be collected prospectively at five points in time: Day 0; Month 3 after inclusion; Month 6 after inclusion; Month 9 after inclusion; Month 12 after inclusion
Prevalence of patients with treatment
Number of participants with treatment before and after the intervention per 1000 patients >64 years of age attended in 1 year
Measured: Data will be collected prospectively at two points in time: Day 0, Month 12 after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start1 Jan 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Overactive Bladder SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group: Patients with mirabegron prescription from 1st January 2017 to 31st December 2017 assigned to any of the 17 urban primary health care centers located in the northern area of Barcelona belong to the Catalan Institute of Health (CIH). Control group (CG): All the other patients with mirabegron prescription assigned to any of the other 34 PHC located in Barcelona belonging to the CIH.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,932 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catalan Institute of Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eladio Fernandez Liz, Catalan Institute of Health
- Investigators
- Eladio Fernández-Liz, PhD, Principal investigator, PharmacistPedro Vivó Tristante, Physician, Study director, Director. Primary Health Care Center Montcada i ReixacAntonio Aranzana Martínez, Physician, Study chair, Director. Primary Health Care Center Rio de JaneiroMª Estrella Barceló Colomer, Physician, Study chair, Clinical PharmacologistJosé Ossó Rebull, Physician, Study chair, Director. Primary Health Care Center Sant AndreuMaría José López-Dolcet, Physician, Study chair, Director. Primary Health Care Center Service Muntanya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536494
- Sponsor's protocol ID
- ICS-MIR-2018-01
- Status last verified
- Nov 2018
- First submitted
- 23 Apr 2018
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006 Dec;50(6):1306-14; discussion 1314-5. doi: 10.1016/j.eururo.2006.09.019. Epub 2006 Oct 2.
PubMed 17049716Reeve E, Gnjidic D, Long J, Hilmer S. A systematic review of the emerging de fi nition of 'deprescribing' with network analysis: implications for future research and clinical practice. Br J Clin Pharmacol. 2015 Dec;80(6):1254-68. doi: 10.1111/bcp.12732.
PubMed 27006985Scott IA, Hilmer SN, Reeve E, Potter K, Le Couteur D, Rigby D, Gnjidic D, Del Mar CB, Roughead EE, Page A, Jansen J, Martin JH. Reducing inappropriate polypharmacy: the process of deprescribing. JAMA Intern Med. 2015 May;175(5):827-34. doi: 10.1001/jamainternmed.2015.0324.
PubMed 25798731Wagg A, Franks B, Ramos B, Berner T. Persistence and adherence with the new beta-3 receptor agonist, mirabegron, versus antimuscarinics in overactive bladder: Early experience in Canada. Can Urol Assoc J. 2015 Sep-Oct;9(9-10):343-50. doi: 10.5489/cuaj.3098.
PubMed 26644809Chapple CR, Cruz F, Deffieux X, Milani AL, Arlandis S, Artibani W, Bauer RM, Burkhard F, Cardozo L, Castro-Diaz D, Cornu JN, Deprest J, Gunnemann A, Gyhagen M, Heesakkers J, Koelbl H, MacNeil S, Naumann G, Roovers JWR, Salvatore S, Sievert KD, Tarcan T, Van der Aa F, Montorsi F, Wirth M, Abdel-Fattah M. Consensus Statement of the European Urology Association and the European Urogynaecological Association on the Use of Implanted Materials for Treating Pelvic Organ Prolapse and Stress Urinary Incontinence. Eur Urol. 2017 Sep;72(3):424-431. doi: 10.1016/j.eururo.2017.03.048. Epub 2017 Apr 14.
PubMed 28413126Wagg AS, Foley S, Peters J, Nazir J, Kool-Houweling L, Scrine L. Persistence and adherence with mirabegron vs antimuscarinics in overactive bladder: Retrospective analysis of a UK General Practice prescription database. Int J Clin Pract. 2017 Oct;71(10). doi: 10.1111/ijcp.12996. Epub 2017 Sep 14.
PubMed 28906080Duckett J, Balachandran A. Tolerability and persistence in a large, prospective case series of women prescribed mirabegron. Int Urogynecol J. 2016 Aug;27(8):1163-7. doi: 10.1007/s00192-016-2945-4. Epub 2016 Jan 23.
PubMed 26803838
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Structured Intervention to Optimize Both the Use of Mirabegron, a β3 Receptor Agonist, and Facilitate Its Discontinuation: a Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT03536494
- Acronym / sponsor ID
- ICS-MIR-2018-01
- Conditions
- Overactive Bladder Syndrome
- Keywords
- Overactive bladder, Mirabegron, Persistence, Patient-Centered Care, Inappropriate prescribing, Discontinuation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,932 participants (actual)
- Lead sponsor
- Catalan Institute of HealthOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 24 May 2018 (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.
This study was a multicentre, quasi-experimental design, controlled, before-and-after trial to estimate the effectiveness related to the review of mirabegron use and, if appropriate, its discontinuation.
Intervention group: Patients with mirabegron prescription assigned to any of the 17 primary health care centers (PHC) located in the northern area of Barcelona.
Control group: All the other patients assigned to any of the other 34 health care centers in Barcelona belonging to the Catalan Institut of Health (CIH).
The structured intervention included initiatives with general practitioners and urologists/gynaecologists, management support from health care authorities, and monthly feed-back monitoring to general practitioners (GPs).
The follow-up period was 12 months, from January 1st to December 31st, 2017.
Detailed description
A quasi-experimental design with before/after measurement and a control group was used.
The objective was to identify the effectiveness of a training activity on the review of treatments. In addition, it was proposed to establish the duration of medication in real clinical practice, and its prevalence of use before and after the intervention.
Control group: Usual care
Intervention:
- Initiatives for healthcare professionals: information and training with written material, in an diagram format, distributed to all general practitioners.
- Initiatives for specialized hospital care: information regarding the intervention for urologists and gynaecologists.
- Management support with the definition of a structured strategy for all the addresses of the PHC and GPs.
- Monthly monitoring of the intervention (feed-back to all GPs).
The intervention consisted of: a) meetings with all the directors of the PHC; b) informative meetings and sessions in the PHC; c) distribution of the diagram to all the GPs; d) lists of patients with treatment provided periodically from the medication area; and e) review of the treatments by the GPs.
If considered appropriate, and with the consent of the patient, the medication was withdrawn.
A pharmacist and a clinical pharmacologist acted as consultants in case of any doubts regarding specific patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Intervention group: Patients with mirabegron prescription from 1st January 2017 to 31st December 2017 assigned to any of the 17 urban primary health care centers located in the northern area of Barcelona belong to the Catalan Institute of Health (CIH). Control group (CG): All the other patients with mirabegron prescription assigned to any of the other 34 PHC located in Barcelona belonging to the CIH.
| Arm | Type | Receives |
|---|---|---|
| Mirabegron intervention | Experimental | Behavioral: Review the use of mirabegron and its discontinuationReview the use of mirabegron and its discontinuation |
| Control group | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients ≥ 18 years with mirabegron prescription. The prescription could be performed by a hospital or primary care doctor.
Key exclusion criteria (1 listed)
- Patients under 18 years
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 |
|---|---|---|
| Review the use of mirabegron and its discontinuationA structured intervention was designed consisting of four major sections: * General practitioners: information and training with written material and patient-centred prescribing. * Specialized hospital care: information regarding the intervention for urologists and gynaecologists. * Management support with the definition of a structured strategy. * Monthly monitoring of the intervention. | Behavioural | Mirabegron intervention |
Primary outcome
Change from baseline of the number of participants with treatment
Time frame: Data will be collected prospectively at five points in time: Day 0; Month 3 after inclusion; Month 6 after inclusion; Month 9 after inclusion; Month 12 after inclusion
The percentage of change from baseline of the number of participants with treatment at 3, 6, 9 and 12 months with respect to basal values (day 0)
2 secondary outcomes
Change from baseline of the duration of treatment at 3, 6, 9, and 12 months with respect to basal values (day 0)
Time frame: Data will be collected prospectively at five points in time: Day 0; Month 3 after inclusion; Month 6 after inclusion; Month 9 after inclusion; Month 12 after inclusion
Prevalence of patients with treatment
Time frame: Data will be collected prospectively at two points in time: Day 0, Month 12 after inclusion
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 7 Nov 2018.
- Results publication: PubMed 17049716Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006 Dec;50(6):1306-14; discussion 1314-5. doi: 10.1016/j.eururo.2006.09.019. Epub 2006 Oct 2.
- Results publication: PubMed 27006985Reeve E, Gnjidic D, Long J, Hilmer S. A systematic review of the emerging de fi nition of 'deprescribing' with network analysis: implications for future research and clinical practice. Br J Clin Pharmacol. 2015 Dec;80(6):1254-68. doi: 10.1111/bcp.12732.
- Results publication: PubMed 25798731Scott IA, Hilmer SN, Reeve E, Potter K, Le Couteur D, Rigby D, Gnjidic D, Del Mar CB, Roughead EE, Page A, Jansen J, Martin JH. Reducing inappropriate polypharmacy: the process of deprescribing. JAMA Intern Med. 2015 May;175(5):827-34. doi: 10.1001/jamainternmed.2015.0324.
- Results publication: PubMed 26644809Wagg A, Franks B, Ramos B, Berner T. Persistence and adherence with the new beta-3 receptor agonist, mirabegron, versus antimuscarinics in overactive bladder: Early experience in Canada. Can Urol Assoc J. 2015 Sep-Oct;9(9-10):343-50. doi: 10.5489/cuaj.3098.
- Results publication: PubMed 28413126Chapple CR, Cruz F, Deffieux X, Milani AL, Arlandis S, Artibani W, Bauer RM, Burkhard F, Cardozo L, Castro-Diaz D, Cornu JN, Deprest J, Gunnemann A, Gyhagen M, Heesakkers J, Koelbl H, MacNeil S, Naumann G, Roovers JWR, Salvatore S, Sievert KD, Tarcan T, Van der Aa F, Montorsi F, Wirth M, Abdel-Fattah M. Consensus Statement of the European Urology Association and the European Urogynaecological Association on the Use of Implanted Materials for Treating Pelvic Organ Prolapse and Stress Urinary Incontinence. Eur Urol. 2017 Sep;72(3):424-431. doi: 10.1016/j.eururo.2017.03.048. Epub 2017 Apr 14.
- Results publication: PubMed 28906080Wagg AS, Foley S, Peters J, Nazir J, Kool-Houweling L, Scrine L. Persistence and adherence with mirabegron vs antimuscarinics in overactive bladder: Retrospective analysis of a UK General Practice prescription database. Int J Clin Pract. 2017 Oct;71(10). doi: 10.1111/ijcp.12996. Epub 2017 Sep 14.
- Results publication: PubMed 26803838Duckett J, Balachandran A. Tolerability and persistence in a large, prospective case series of women prescribed mirabegron. Int Urogynecol J. 2016 Aug;27(8):1163-7. doi: 10.1007/s00192-016-2945-4. Epub 2016 Jan 23.
- Individual participant dataSharing planned: Undecided
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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.
Eladio Fernández-Liz, PhD principal investigator
Pharmacist
Pedro Vivó Tristante, Physician study director
Director. Primary Health Care Center Montcada i Reixac
Antonio Aranzana Martínez, Physician study chair
Director. Primary Health Care Center Rio de Janeiro
Questions about this trial
What is this clinical trial studying?
A study testing Review the use of mirabegron and its discontinuation in people with Overactive Bladder Syndrome, run by Catalan Institute of Health.
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 1 inclusion and 1 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 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from baseline of the number of participants with treatment (time frame: Data will be collected prospectively at five points in time: Day 0; Month 3 after inclusion; Month 6 after inclusion; Month 9 after inclusion; Month 12 after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03536494, which also lists 7 linked publications.
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 7 Nov 2018.