Benign prostatic hyperplasia
Conditions
Interventions
Tadalafil monotherapy group: Group A Tadalafil at the dose of 5mg is orally administered once daily after breakfast for 12 weeks.
Tadalafil/mirabegron combination therapy group: Group B Tadalafil
Sponsors
Clinical Research Support Center Kyushu
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Male patients with BPH. 2) Patients who meet the following criteria even after administering tadalafil 5mg/day for more than 8 weeks: OABSS total score >3 Urgency > once/week (OABSS urgency score >= 2) 3) Aged >=50 years and < 90 years 4) Patients who are able to give informed consent. 5) Patients from whom we have received written consent.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to end of treatment in overactive bladder symptom score (OABSS) total score. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactTomonori Yamanishi
Dokkyo Medical University Department of Urology and Neurology, Continence Center
Outcome results
None listed