Benign Prostatic Hyperplasia
Conditions
Interventions
Chlormadinone Acetate(CMA) One year 25 mg per time 2 times per day
Sponsors
Kobe University Graduate of Medicine
Shakaihoken Kobe Central Hospital Kobe City Medical Center West Hospital Miki City Hospital Shinko Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: The BPH patient whose curative effect by DUT was insufficient for one year or more. (Patients who has provided written informed consent) In addition, the criteria of insufficiency are as followed; prostate gland volume > 30cc, IPSS > 8, QOL score > 2, and rate of maximum urine flow < 15 mL/s.
Exclusion criteria
Exclusion criteria: 1)Patients with suspected prostate cancer by PSA or DRE. 2)Patients with suspected Neurogenic Bladder. 3)Patients with urethral stricture. 4)Patients who gave radiotherapy in the pelvis. 5)Patients with chronic urinary tract infection, active cystitis interstitial. 6)Patients with serious liver damage / liver disease. 7)Patients with heart disease, renal disease or Anamnesis. 8)Diabetic 9)Patients was deemed by the physician as inappropriate to attend.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction rate of Prostate Volume | — |
Secondary
| Measure | Time frame |
|---|---|
| International Prostatic Symptom Score (I-PSS), QOL-Score, maximum urinary flow rate, residual urine volume, blood test(AST, ALT, blood glucose), Adversed Event, tumor marker(serum PSA), free Testosterone | — |
Countries
Japan
Outcome results
None listed