Status:
TERMINATED
Photodynamic Therapy (PDT) for Lower Urinary Tract Symptoms (PLUS)
Lead Sponsor:
QLT Inc.
Conditions:
Prostatic Hyperplasia
Eligibility:
MALE
21+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if transurethral photodynamic therapy with lemuteporfin has a therapeutic effect on lower urinary tract symptoms due to an enlarged prostate. Photodynamic th...
Detailed Description
This is a multi-center, randomized, sham-controlled, double-blind, dose-finding study in parallel groups of subjects with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH)....
Eligibility Criteria
Inclusion
- Men 21 years of age and older.
- Subjects with LUTS due to BPH with AUA SI scores of 13 and over and Qmax between 5 and 15 mL/sec.
- Subjects with urethral treatment length of at least 25 mm.
Exclusion
- Subjects who have had previous minimally invasive or surgical treatment for BPH.
- Subjects who have unsuitable prostate dimensions.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00116571
Start Date
May 1 2005
End Date
December 1 2006
Last Update
October 3 2006
Active Locations (9)
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1
San Bernardino Urological Associates
San Bernardino, California, United States, 92404
2
Regional Urology, LLC
Shreveport, Louisiana, United States, 71106
3
Drs Werner, Murdock & Francis PA Urology Associates
Greenbelt, Maryland, United States, 20770
4
Lawrenceville Urology
Lawrenceville, New Jersey, United States, 08648