Botulinum Toxin Injection for the Management of BPH

PHASE2CompletedINTERVENTIONAL
Enrollment

134

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

June 30, 2009

Study Completion Date

December 31, 2009

Conditions
Benign Prostatic Hyperplasia
Interventions
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.

Trial Locations (7)

10021

Cornell University, New York

53226

Medical College of Wisconsin, Milwaukee

55905

Mayo Clinic, Rochester

60611

Northwestern University, Chicago

75390

University of Texas Southwestern Medical Center, Dallas

77030

Baylor College of Medicine, Houston

80010

University of Colorado Health Sciences Center, Denver

All Listed Sponsors
collaborator

George Washington University

OTHER

lead

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

NCT00451191 - Botulinum Toxin Injection for the Management of BPH | Biotech Hunter | Biotech Hunter