Conditions: Benign Prostatic Hyperplasia
Keywords: benign prostatic hyperplasia BPH botulinum toxin BoNT/A
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 134
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 100 units botulinum toxin type A (BoNT/A) arm 2: 300 units botulinum toxin type A (BoNT/A)

Interventions: intervention 1: botulinum toxin type A (BoNT/A)
Intervention descriptions: intervention 1: 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.

Protocol document: