Botox for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

Chronic Pain Syndrome Clinical Trial

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

Status Terminated

Clinical Trial 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).

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain Syndrome
• Pelvic Pain
• Prostatitis
• Somatoform Disorders
• Syndrome

• NCT number: NCT00529386
• Study type: Interventional
• Source: Queen's University
• Status: Terminated
• Phase: Phase 1
• Start date: January 2006
• Completion date: December 2009