CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 134 enrolled
Drug / intervention
botulinum toxin type A (BoNT/A)drug
Likely dose
botulinum toxin type A (BoNT/A) 100 unitfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00451191
NCT00451191Phase 2Completed
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Intraprostatic Injection of Botulinum Toxin for the Management of Benign Prostatic Hyperplasia: A Randomized Phase II Trial

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Mar 23, 2007·Updated Apr 21, 2020

In Brief

A Phase 2 clinical trial evaluating botulinum toxin type A (BoNT/A) for Benign Prostatic Hyperplasia. Completed, enrolled 134 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBenign Prostatic Hyperplasia
CountriesUnited States
CollaboratorsGeorge Washington University

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 23, 2007
Enrollment StartOct 1, 2006
Primary CompletionJun 1, 2009
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 19.3 years ago

Interventions

botulinum toxin type A (BoNT/A)drug

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.