Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00274417
Status:
UNKNOWN
Last Update Posted:
2007-04-18
First Post:
2006-01-09
Brief Title:
Dutasteride for Improving Peri-Operative and Long-Term Outcomes of Photoselective Vaporization of the Prostate DOP
Sponsor:
Urology of Virginia
Organization:
Urology of Virginia
Study Overview
Official Title:
A Randomized Placebo-Controlled Double-Blind Study of the Use of Dutasteride for Improving Peri-Operative and Long-Term Outcomes of Photoselective Vaporization of the Prostate DOP Study
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is for individuals electing to have GreenLight Photoselective Vaporization of the Prostate PVP to treat symptoms from an enlarged prostate gland The purpose of this research study is to evaluate the safety and effectiveness of the medication dutasteride as compared to placebo an inactive substance for improving surgical and long-term outcomes of PVP Dutasteride is approved by the United States Food and Drug Administration FDA for the treatment of symptoms from an enlarged prostate gland The use of dutasteride to improve the outcomes of PVP is investigational The study will last for approximately 15 months and will involve 6 visits
Detailed Description:
The purpose of the study is to assess the effects of dutasteride on the outcomes and QoL of patients undergoing GreenLight Photoselective Vaporization of the Prostate PVP is a growing outpatient surgical treatment for BPH The addition of dutasteride may potentially improve both the short and long term outcomes Use peri-operatively may improve visibility during surgery shorten operative time lessen bleeding both intra and post-operatively and hasten post-op recovery Continued use long-term 12 months following the procedure may improve overall symptomatic scores as combination therapy with PVP The addition of dutasteride to PVP may decrease the occasional occurrence of continued post-op irritative symptoms and lessen the likelihood of the need for re-catheterization with overall improvement in quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None