A pilot study of the generic drug of Tamsulosin Hydrochloride to evaluate the efficacy for benign prostatic hyperplasia patients with dysuria.
- Conditions
- benign prostatic hyperplasia
- Registration Number
- JPRN-UMIN000003907
- Lead Sponsor
- PO MINS
- Brief Summary
The I-PSS and the QOL score were significantly decreased after 4 weeks dosing of Restream®. And the safety profile was similar to that of the original drug. These results confirmed that 4 weeks treatment by the generic drug of Tamsulosin Hydrochloride, Restream®OD tablet, would be effective and be safety for BPH with moderate to severe dysuria.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 20
Not provided
1) Patients who treated by medicine that has androgenic hormone within 4 weeks before IC. 2) Patients with cases or suspicion of prostatic cancer 3) Patients with suspicion of neurogenic bladder 4) Patients with urethral stricture 5) Patients with chronic bacterial prostatitis or active urinary tract infection 6) Past history of surgery or invasive therapy for BPH. 7) Irradiation for pelvic area within 1 year prior to IC. 8) Patients with any disease that induce dysuria (such as bladder neck contracture or urolithiasis) 9) Patients with cardiovascular disease. 10) Patients with serious disease or impairment of liver, kidney and blood 11) patients who are participated in any clinical studies within 3 months prior to the study 12) Patients who are judged inappropriate for the clinical trial by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method international prostate symptom score : I-PSS QOL score
- Secondary Outcome Measures
Name Time Method roflowmetry (if available at the study site) Safety(vital, labo test, AEs) Drug compliance