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

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Joseph's Healthcare Hamilton
• Treatments: Mirabegron; Tamsulosin

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