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.

Sponsors

Lead Sponsor: St. Joseph's Healthcare Hamilton

Source St. Joseph's Healthcare Hamilton
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.

Overall Status Not yet recruiting
Start Date 2021-12-01
Completion Date 2022-12-01
Primary Completion Date 2022-12-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
International Prostate Symptom Score (IPSS) Treatment period: 4 weeks
Quality of Life Score (QoLS) Treatment period: 4 weeks
Overactive Bladder Symptom Score (OABSS) Treatment period: 4 weeks
Secondary Outcome
Measure Time Frame
Adverse Events Timeline: 4 weeks
Enrollment 200
Condition
Intervention

Intervention Type: Drug

Intervention Name: Mirabegron

Description: 50mg of mirabegron per day will be given.

Arm Group Label: Treatment Group

Other Name: Myrbetriq

Intervention Type: Drug

Intervention Name: Tamsulosin

Description: 0.4mg of flomax per day.

Other Name: Flomax

Eligibility

Criteria:

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

Gender:

Male

Minimum Age:

50 Years

Maximum Age:

90 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Anil Kapoor, MD, FRCSC Principal Investigator McMaster University
Overall Contact

Last Name: Taehyoung Lee, MD, PGY4

Phone: 905-522-1155

Phone Ext.: 36188

Email: [email protected]

Location
Facility: St. Joseph's Healthcare Hamilton - McMaster Institute of Urology
Location Countries

Canada

Verification Date

2021-03-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: St. Joseph's Healthcare Hamilton

Investigator Full Name: Anil Kapoor

Investigator Title: MD, FRCSC

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Treatment Group

Type: Active Comparator

Description: (Mirabegron + Tamsulosin)

Label: Control Group

Type: Placebo Comparator

Description: (Placebo + Tamsulosin)

Study Design Info

Allocation: Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

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