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 25, 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|