Benign Prostatic Hyperplasia Clinical Trial
Official title:
On Label, Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Finasteride in Patients Undergoing Transurethral Resection of the Prostate (TURP)
Verified date | November 2009 |
Source | University of Alberta |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Transurethral resection of the prostate (TURP) is a common treatment for benign prostatic
hyperplasia (BPH). A common complication of TURP is blood loss. Preliminary data suggest that
preoperative Finasteride, a 5 alpha-reductase inhibitor, may reduce blood loss during TURP.
However, no study has examined the effect of preoperative Finasteride on clinical outcomes.
The study is a randomized, double-blind, placebo-controlled trial of preoperative Finasteride
versus placebo in BPH patients undergoing TURP. Participants will be stratified by prostate
volume (30 to 65 grams versus 66 to 100 grams) and randomly assigned to preoperative
Finasteride or placebo. The primary end point is incidence of RBCT. Secondary end points are
standard units of red blood cells transfused, variables related to perioperative bleeding
(incidence of readmission, incidence of return to hospital, length of hospital stay), blood
loss, change in serum hemoglobin, change in serum hematocrit, blood loss per gram of resected
prostate tissue, operating time, change in AUA-SS, and change in HRQOL.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 2011 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. TRUS-confirmed prostate gland > 30 g, 2. 18 years of age or older, 3. fit and scheduled to receive TURP, 4. approval of the treating urologist, 5. able to understand and provide written informed consent in English Exclusion Criteria: 6. active psychiatric condition, 7. previous Finasteride use, 8. abnormal DRE, 9. PSA greater than 4.0 ng/ml, 10. current anticoagulation use (Heparin, Warfarin), 11. ESRD, 12. previous prostate or urethral surgery, 13. deemed to be a candidate for immediate surgery (within 1 week of initial evaluation). |
Country | Name | City | State |
---|---|---|---|
Canada | Alberta Urology Institute | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta | Merck Frosst Canada Ltd. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare the incidence of red blood cell transfusion after TURP in BPH patients randomized to receive preoperative Finasteride with those randomized to receive placebo. | During/post surgery | ||
Secondary | To compare standard units of red blood cells transfused, variables related to perioperative bleeding, blood loss, serum hemoglobin, serum hematocrit, blood loss per gram of resected prostate tissue, operating time, AUA-SS, HRQOL after TURP | during/post surgery |
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