None listed
Conditions
Interventions
Drug : [arm1] alfuzosin HCl 10mg q.d. 12weeks
propiverine HCl 10mg q.d. 12weeks
[arm2] alfuzosin HCl 10mg q.d. 12weeks
propiverine HCl placebo 10mg q.d. 12weeks
Sponsors
Inha University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. signed Informed consent form 2. Male aged more than 45 3. IPSS more than 12 4. Enlarged prostate on DRE 5. Symptoms of urinary urgency with voiding 3/day 6. Symptoms of urinary frequency (8 micturitions per 24 hours) 7. Symptoms of LUTS more than 3 months 8. understanding and agreed the purpose of trial
Exclusion criteria
Exclusion criteria: 1. Total daily urine volume of > 3000 ml 2. Initial RU more than 150ml 3. Significant hepatic or renal disease (twice the upper limit of the reference ranges for serum concentrations of AST [SGOT], ALT [SGPT], alkaline phosphatase or creatinine) 4. Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention 5. Symptomatic acute urinary tract infection (UTI) during the run-in period 6. Recurrent UTIs defined as having been treated for symptomatic UTIs > 4 times in the last year 7. Diagnosed or suspected interstitial cystitis 8. Clinically significant hematuria or hematuria secondary to malignant disease. 9. PSA more than 10ng/dl (can include PSA between 4 and 10 if biopsy is negative) 10. Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with any anticholinergic drugs other than randomized trial drug 11. Receipt of any electrostimulation or bladder training within the 14 days before randomization, or expected to start such treatment during the study 12. An indwelling catheter or practicing intermittent self-catheterization 13. Use of any investigational drug within 2 months preceding the start of the study 14. Patients with chronic constipation or history of severe constipation 15. Patients who have bladder cancer or prostate cancer 16. History of bladder and prostate surgery 17. suspicious prostatitis 18. suspicious neurogenic bladder 19. Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| urgency episodes with voiding | — |
Secondary
| Measure | Time frame |
|---|---|
| urgency episodes without voiding ;number of total voiding;number of total urgency;number of nocturia;voided volume of one time;IPSS score;OABSS score;OABqSF score;Global Impression of improvement score;uroflowmetry and PVR ;Incidence of acute urinary retention requiring catheterization;Voiding difficulties requiring study medication to be discontinued;Incidence and severity of adverse events;Incidence and reason of withdrawals | — |
Countries
Korea, Republic of
Contacts
Public ContactWonhee Park
Inha University Hospital
Outcome results
None listed