Botox for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00529386|
Recruitment Status : Terminated
First Posted : September 14, 2007
Results First Posted : March 11, 2019
Last Update Posted : March 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostatitis Chronic Pain Syndrome||Drug: Botox||Phase 1|
This is a prospective open label study examining the efficacy and safety of intraprostatic Botox . Men with a clinical diagnosis of chronic nonbacterial prostatitis/CPPS will be treated with intraprostatic Botox™ and followed for 12 weeks (primary efficacy analyses), and 24 weeks (long term follow-up) for responders.
It is proposed that 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).
Outcome measures include Chronic Prostatitis Symptom Index (CPSI 0-35), NRS pain (0-10), Global Response Assessment (GRA) at 12 weeks. Safety to be monitored during the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Pilot Study to Evaluate the Safety and Efficacy of Botox™ for the Treatment of Men Diagnosed With Chronic Prostatitis/Chronic Pelvic Pain Syndrome|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||December 2009|
300 IU botox
Other Name: Botulinem toxin
- GRA [ Time Frame: 12 weeks ]At 12 weeks there were no GRA responders. Study stopped because of futility.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00529386
|Centre for Advanced Urological Research|
|Kingston, Ontario, Canada, K7L 3J7|
|Principal Investigator:||J. Curtis Nickel, MD FRCSC||Queen's University|