Clinical Trial: Botox for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Prospective Pilot Randomized Sham Controlled Study to Evaluate the Safety and Efficacy of Botox™ for the Treatment of Men Diagnosed With Chronic Prostatitis/Chroni
Brief Summary: The objective of this study is to evaluate the safety and efficacy of intraprostatic injection of Botox for the treatment of men diagnosed with chronic nonbacterial prostatitis/chronic pelvic pain syndrome (CP/CPPS).
Detailed Summary:
This is a blinded prospective randomized design comparing the efficacy and safety of intraprostatic Botox vs. intraprostatic lidocaine injection, with an optional open label extension. Men with a clinical diagnosis of chronic nonbacterial prostatitis/CPPS will be treated with intraprostatic Botox™ or 1% lidocaine and followed for 12 weeks (primary efficacy analyses), and 24 weeks (long term follow-up) for responders. An open label extension will be offered to non-responders.
A total of 40 males will be enrolled. There will be seven (7) research clinic visits and two phone contacts: Visit 1 (screening), Visit 2 (baseline/treatment), Visit 3 (2-week safety evaluation - clinic contact), Visit 4 (4-week safety evaluation - phone contact), Visit 5 (6-week interim efficacy/safety), Visit 6 (12-week primary endpoint evaluation), Visit 7 (14-week clinic follow up), Visit 8 (16 week phone contact) and Visit 9 (24-week clinic close out).
Sponsor: Queen's University
Current Primary Outcome: GRA [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Safety [ Time Frame: 12 Weeks ]
- NIH-CPSI [ Time Frame: 12 Weeks ]
Original Secondary Outcome: Same as current
Information By: Queen's University
Dates:
Date Received: September 12, 2007
Date Started: January 2006
Date Completion:
Last Updated: September 13, 2011
Last Verified: June 2009
