Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00529386
Status:
TERMINATED
Last Update Posted:
2019-03-25
First Post:
2007-09-12
Brief Title:
Botox for Chronic ProstatitisChronic Pelvic Pain Syndrome CPCPPS
Sponsor:
Queens University
Organization:
Queens University
Study Overview
Official Title:
A Prospective Pilot Study to Evaluate the Safety and Efficacy of Botox for the Treatment of Men Diagnosed With Chronic ProstatitisChronic Pelvic Pain Syndrome
Status:
TERMINATED
Status Verified Date:
2019-03
Last Known Status:
None
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:
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 prostatitischronic pelvic pain syndrome CPCPPS
Detailed Description:
This is a prospective open label study examining the efficacy and safety of intraprostatic Botox Men with a clinical diagnosis of chronic nonbacterial prostatitisCPPS 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 baselinetreatment Visit 3 2-week safety evaluation - clinic contact Visit 4 4-week safety evaluation - phone contact Visit 5 6-week interim efficacysafety 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
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 baselinetreatment Visit 3 2-week safety evaluation - clinic contact Visit 4 4-week safety evaluation - phone contact Visit 5 6-week interim efficacysafety 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None