Skip to content

Efficacy And Safety Of Combination Therapy For Treatment Of Overactive Bladder In Male Patients With Benign Prostatic Hyperplasia.

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.

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02279615
Enrollment
200
Registered
2014-10-31
Start date
2021-12-31
Completion date
2022-12-31
Last updated
2021-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia, Overactive Bladder

Keywords

Overactive Bladder, Benign Prostatic Hyperplasia, Combination Therapy, β3-Adrenoceptor Agonist, Mirabegron, Myrbetriq, α-Adrenoceptor Antagonist, Tamsulosin, Flomax

Brief 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.

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.

Interventions

DRUGMirabegron

50mg of mirabegron per day will be given.

DRUGTamsulosin

0.4mg of flomax per day.

Sponsors

St. Joseph's Healthcare Hamilton
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
50 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
International Prostate Symptom Score (IPSS)Treatment period: 4 weeksMeasured before and after combination therapy.
Quality of Life Score (QoLS)Treatment period: 4 weeksMeasured before and after combination therapy
Overactive Bladder Symptom Score (OABSS)Treatment period: 4 weeksMeasured before and after combination therapy

Secondary

MeasureTime frameDescription
Adverse EventsTimeline: 4 weeksMeasured during treatment of combination therapy.

Countries

Canada

Contacts

Primary ContactTaehyoung Lee, MD, PGY4
taehyoung.lee@medportal.ca905-522-1155
Backup ContactCamilla Tajzler, BA, CCRA
tajzlec@mcmaster.ca905-522-1155

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026