Overactive BladderPhase 4NCT02279615
Efficacy And Safety Of Combination Therapy For Treatment Of Overactive Bladder In Male Patients With Benign Prostatic Hyperplasia.
A Phase 4 study testing Mirabegron and Tamsulosin in people with Overactive Bladder and Benign Prostatic Hyperplasia, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
The purpose of this study is to investigate the safety and efficacy of combination therapy involving β3-adrenoceptor agonist, mirabegron, and α-blockers for the treatment of OAB symptoms in male patients with BPH. Read more about this study
- Who is it for?
- Ages 50 to 90 years, men only
- Conditions the study is for
- Overactive Bladder, Benign Prostatic Hyperplasia
- What is being tested?
- Mirabegron and Tamsulosin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2021to Dec 2022
- Phase
- Phase 4
- 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 50 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients over the age of 50
- Clinical BPH on stable dose of alpha-blocker therapy for more than 1 month
- OAB symptoms (frequency, urgency, nocturia, urgency incontinence)
Who cannot join
- Post-void residual (PVR) > 200mL
- Active, culture-proven urinary tract infection
- Acute/chronic prostatitis
- Previous lower urinary tract malignancy (i.e. bladder, prostate malignancy)
- History of cystolithiasis
- Previous pelvic surgery (i.e. prostatectomy, cystectomy, recent pelvic/endourologic instrumentation including cystoscopy, nephroscopy, ureteral stent insertion, Transrectal Ultrasound (TRUS) biopsy)
- Previous pelvic radiation
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Joseph's Healthcare Hamilton - McMaster Institute of Urology
Hamilton, Ontario, L8N4A6
About this study
Official title: EFFICACY AND SAFETY OF COMBINATION THERAPY WITH β3-ADRENOCEPTOR AGONIST (MIRABEGRON) AND α-ADRENOCEPTOR ANTAGONIST (TAMSULOSIN) FOR TREATMENT OF OVERACTIVE BLADDER IN MALE PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA.
The purpose of this study is to investigate the safety and efficacy of combination therapy involving β3-adrenoceptor agonist, mirabegron, and α-blockers for the treatment of OAB symptoms in male patients with BPH.
Read the detailed description
Mirabegron (MyrbetriqTM, Astellas Pharma Inc.) is a drug that is approved by the FDA for the treatment of overactive bladder (OAB) with symptoms of urinary frequency, urgency and urgency incontinence. Multiple studies have shown that this drug also has the potential to improve patient tolerability, compliance and subsequent patient quality of life without inducing unfavourable adverse events commonly associated with antimuscarinic medications. These adverse events include, but are not limited to, dry mouth, constipation, confusion, and acute urinary retention (AUR).
Studies now have shown that mirabegron may also provide an effective treatment option for OAB in men with benign prostatic hyperplasia (BPH) without inducing the above mentioned adverse events. This study will look at the combination therapy of Mirabegron and Tamsulosin, versus Tamsulosin and placebo alone to prove that this treatment (Mirabegron and Tamsulosin) is effective for those men who suffer from both overactive bladder along with benign prostatic hyperplasia.
- Conditions
- Overactive Bladder, Benign Prostatic Hyperplasia
- Being tested
- Mirabegron, Tamsulosin
- Keywords
- Overactive Bladder, Benign Prostatic Hyperplasia, Combination Therapy, β3-Adrenoceptor Agonist, Mirabegron, Myrbetriq, α-Adrenoceptor Antagonist, Tamsulosin, Flomax
- Medical subject headings
- Urinary Bladder, Overactive, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirabegronDrug
Also called Myrbetriq
50mg of mirabegron per day will be given.
TamsulosinDrug
Also called Flomax
0.4mg of flomax per day.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Active comparator | (Mirabegron + Tamsulosin) Receives: Drug: Mirabegron; Drug: Tamsulosin |
| Control Group | Placebo comparator | (Placebo + Tamsulosin) Receives: Drug: Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptom Score (IPSS)
Measured before and after combination therapy.
Measured: Treatment period: 4 weeks
Quality of Life Score (QoLS)
Measured before and after combination therapy
Measured: Treatment period: 4 weeks
Overactive Bladder Symptom Score (OABSS)
Measured before and after combination therapy
Measured: Treatment period: 4 weeks
Secondary outcomes (1)
Adverse Events
Measured during treatment of combination therapy.
Measured: Timeline: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startDec 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anil Kapoor, St. Joseph's Healthcare Hamilton
- Investigators
- Anil Kapoor, MD, FRCSC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279615
- Sponsor's protocol ID
- MIRTAM-2014OB
- Status last verified
- Mar 2021
- First submitted
- 10 Oct 2014
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFICACY AND SAFETY OF COMBINATION THERAPY WITH β3-ADRENOCEPTOR AGONIST (MIRABEGRON) AND α-ADRENOCEPTOR ANTAGONIST (TAMSULOSIN) FOR TREATMENT OF OVERACTIVE BLADDER IN MALE PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA.
- ClinicalTrials.gov ID
- NCT02279615
- Acronym / sponsor ID
- MIRTAM-2014OB
- Conditions
- Overactive Bladder, Benign Prostatic Hyperplasia
- Keywords
- Overactive Bladder, Benign Prostatic Hyperplasia, Combination Therapy, β3-Adrenoceptor Agonist, Mirabegron, Myrbetriq, α-Adrenoceptor Antagonist, Tamsulosin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 31 Oct 2014 (estimated)
- 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.
The purpose of this study is to investigate the safety and efficacy of combination therapy involving β3-adrenoceptor agonist, mirabegron, and α-blockers for the treatment of OAB symptoms in male patients with BPH.
Detailed description
Mirabegron (MyrbetriqTM, Astellas Pharma Inc.) is a drug that is approved by the FDA for the treatment of overactive bladder (OAB) with symptoms of urinary frequency, urgency and urgency incontinence. Multiple studies have shown that this drug also has the potential to improve patient tolerability, compliance and subsequent patient quality of life without inducing unfavourable adverse events commonly associated with antimuscarinic medications. These adverse events include, but are not limited to, dry mouth, constipation, confusion, and acute urinary retention (AUR).
Studies now have shown that mirabegron may also provide an effective treatment option for OAB in men with benign prostatic hyperplasia (BPH) without inducing the above mentioned adverse events. This study will look at the combination therapy of Mirabegron and Tamsulosin, versus Tamsulosin and placebo alone to prove that this treatment (Mirabegron and Tamsulosin) is effective for those men who suffer from both overactive bladder along with benign prostatic hyperplasia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Active comparator | Drug: Mirabegron, Drug: Tamsulosin(Mirabegron + Tamsulosin) |
| Control Group | Placebo comparator | Drug: Tamsulosin(Placebo + Tamsulosin) |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male patients over the age of 50
- Clinical BPH on stable dose of alpha-blocker therapy for more than 1 month
- OAB symptoms (frequency, urgency, nocturia, urgency incontinence)
Key exclusion criteria (7 listed)
- Post-void residual (PVR) > 200mL
- Active, culture-proven urinary tract infection
- Acute/chronic prostatitis
- Previous lower urinary tract malignancy (i.e. bladder, prostate malignancy)
- History of cystolithiasis
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 |
|---|---|---|
| MirabegronAlso: Myrbetriq50mg of mirabegron per day will be given. | Drug | Treatment Group |
| TamsulosinAlso: Flomax0.4mg of flomax per day. | Drug | Control Group, Treatment Group |
Primary outcome
International Prostate Symptom Score (IPSS)
Time frame: Treatment period: 4 weeks
Measured before and after combination therapy.
Quality of Life Score (QoLS)
Time frame: Treatment period: 4 weeks
Measured before and after combination therapy
Overactive Bladder Symptom Score (OABSS)
Time frame: Treatment period: 4 weeks
Measured before and after combination therapy
1 secondary outcome
Adverse Events
Time frame: Timeline: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
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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.
Anil Kapoor, MD, FRCSC principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mirabegron and Tamsulosin in people with Overactive Bladder and Benign Prostatic Hyperplasia, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
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 3 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: status not confirmed, as of the sponsor's last update on 19 Mar 2021. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Taehyoung Lee, MD, PGY4 (905-522-1155 ext. 36188, taehyoung.lee@medportal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Prostate Symptom Score (IPSS) (time frame: Treatment period: 4 weeks). The study lists 3 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 19 Mar 2021.