NCT01566292

Intraprostatic Botulinum Toxin Type "A" Injection in Patients With Benign Prostatic Hyperplasia and Unsatisfactory Response to Medical Therapy

Intraprostatic Botulinum Toxin Type "A" Injection in Patients With Benign Prostatic Hyperplasia and Unsatisfactory Response to Medical Therapy: a Randomised, Double-blind, Controlled Trial Using Subjective and Objective Outcomes

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: Male
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The injection of botulinum neurotoxin A into the prostate represents an alternative, minimal invasive treatment in patient with lower urinary tract symptoms (LUTS) associated to benign prostatic hyperplasia (BPH). Objective: To evaluate the effectiveness of BTA in treating patients with symptomatic BPH and unsatisfactory response to combined medical therapy.

Conditions

• Benign Prostatic Hyperplasia (BPH)
• Benign Prostatic Enlargement (BPE)

Interventions

Type	Name	Description
DRUG	BOTOX	Botulinum Toxin type A, 200-300 UI dilued in 6 ml of saline solution

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-09-01
• First posted: 2012-03-29
• Last updated: 2012-03-29

Locations

1 site across 1 country: Italy