A randomized controlled study of the efficacy of Tadalafil monotherapy versus combination of Tadalafil and mirabegron for the treatment of overactive bladder (OAB) associated with benign prostatic hyperplasia (BPH) - CONTACT Study

Clinical Research Support Center Kyushu0 sites170 target enrollmentDecember 15, 2016

Overview

No summary available.

Registry

who.int

Start Date

December 15, 2016

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

Male

Sponsor

Clinical Research Support Center Kyushu

•1\) Patients with a history of hypersensitivity to tadalafil or mirabegron 2\) Medication with anti\-cholinergics, cholinergics,beta\-agonists or antagonists, alpha\-blocker and any other agents for treating pollakisuria/urinary incontinence during 8 weeks prior to the study. (Eligible if the medication was discontinued before tadalafil administration (before 8 weeks or more).5 alpha\-reductase inhibitors or anti\-androgen drugs can be included if they were administered \> 6months and the patients had stable condition). 3\) History or current condition of urinary retention or severe difficulty of urination 4\) Patients with cancer in the part of lower urinary tract such as prostate or bladder, neurogenic bladder, urethra stricture, chronic bacterial prostatitis, symptomatic urinary tract infection, urinary tract stones and interstitial cystitis 5\) Patients with serious cardiac disorder, serious cerebrovascular disease, serious liver dysfunction and serious kidney dysfunction 6\) Qmax \< 5 mL/sec 7\) Postvoid residual volume (PVR) \>150 mL 8\) Any other patients who are regarded as unsuitable for this study by the investigator.