Status:
COMPLETED
Effect of Dutasteride on Bladder Wall Hypertrophy in Patients With Benign Prostatic Obstruction
Lead Sponsor:
Samsung Medical Center
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
50-79 years
Phase:
PHASE4
Brief Summary
Increased bladder mass occurs as a consequence of bladder outlet obstruction in animals and patients, and relief of bladder outlet obstruction reverses an increased bladder mass. Whether increased bla...
Detailed Description
1 Objective 1.1 Primary Objective: To explore the efficacy of Dutasteride in reducing bladder wall hypertrophy from baseline to 6 months of treatment in male patients with benign prostatic obstructio...
Eligibility Criteria
Inclusion
- Age≥50 and \<80 years old
- Presence of LUTS for at least 3 months
- IPSS≥15
- Bladder outlet obstruction confirmed by pressure-flow study (BOOI \> 20)
- Prostate volume measured by TRUS ≥ 30ml and \< 100ml
- Able to comply with the prescribed treatment protocol and evaluations.
Exclusion
- Patients with neurogenic voiding disorders
- Patients with prostate or bladder cancer
- Patients underwent urethral, prostate or bladder neck surgery
- Patients with urethral stricture or bladder neck contracture
- Serum PSA≥4ng/ml (if the patient confirmed as no malignancy by prostate biopsy can be included).
- Patients who medicated with 5ARI within 6 months
- Patients who do not agree with the informed consent
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00827814
Start Date
June 1 2006
End Date
April 1 2009
Last Update
June 11 2009
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 135-710