NCT00451191

Botulinum Toxin Injection for the Management of BPH

Intraprostatic Injection of Botulinum Toxin for the Management of Benign Prostatic Hyperplasia: A Randomized Phase II Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blind randomized phase II trial to determine whether two different doses of BoNT/A injection into the prostate gland demonstrate sufficient improvement in the management of lower urinary symptoms due to BPH to warrant more extensive research. Subjects will receive either a 100U or 300U dose. Participation will last 1 year.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	botulinum toxin type A (BoNT/A)	100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.

Timeline

• Start date: 2006-10-01
• Primary completion: 2009-06-01
• Completion: 2009-12-01
• First posted: 2007-03-23
• Last updated: 2020-04-21
• Results posted: 2013-06-24

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study