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)
- Conditions
- Benign prostatic hyperplasia
- Registration Number
- JPRN-UMIN000025282
- Lead Sponsor
- Clinical Research Support Center Kyushu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 170
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline to end of treatment in overactive bladder symptom score (OABSS) total score.
- Secondary Outcome Measures
Name Time Method 1) Changes in OABSS subscore (daytime frequency, night-time frequency, urgency, urgent incontinence). 2) Changes in international prostate symptom score (IPSS) total score and subscore (void, storage, postvoid, QOL). 3) Change in National Institute of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) total score and subscore (pain, urination, QOL). 4) Changes in the parameters in frequency volume chart (number of void/ 24 hour, number of night-time void, number of urgency episodes/24 hour, number of incontinence episodes/24 hour). 5) Changes in postvoid residual (PVR) volume. 6) Changes in urine volume, Qmax and Qave. 7) Frequency of adverse events.