NCT00529386

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Queen's University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Prostatitis
• Chronic Pain Syndrome

Interventions

Type	Name	Description
DRUG	Botox	300 units

Timeline

• Start date: 2006-01-01
• Primary completion: 2009-09-01
• Completion: 2009-12-01
• First posted: 2007-09-14
• Last updated: 2019-03-25
• Results posted: 2019-03-11

Locations

1 site across 1 country: Canada