Status:
UNKNOWN
Efficacy And Safety Of Combination Therapy For Treatment Of Overactive Bladder In Male Patients With Benign Prostatic Hyperplasia.
Lead Sponsor:
St. Joseph's Healthcare Hamilton
Conditions:
Overactive Bladder
Benign Prostatic Hyperplasia
Eligibility:
MALE
50-90 years
Phase:
PHASE4
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 patie...
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT02279615
Start Date
December 1 2021
End Date
December 1 2022
Last Update
March 19 2021
Active Locations (1)
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1
St. Joseph's Healthcare Hamilton - McMaster Institute of Urology
Hamilton, Ontario, Canada, L8N4A6