NCT00451191

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2006

Typical duration for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

June 24, 2013

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

2.7 years

First QC Date

March 21, 2007

Results QC Date

June 20, 2013

Last Update Submit

April 13, 2020

Conditions

Benign Prostatic Hyperplasia

Keywords

benign prostatic hyperplasiaBPHbotulinum toxinBoNT/A

Outcome Measures

Primary Outcomes (1)

  • Improvement in the AUA Symptom Score Index by 30% From Baseline Within the First 12 Weeks After Injection.

    The primary outcome was treatment success at 3 months post-treatment, defined as (1) improvement in the AUASI by at least 30% and/or (2) Qmax improvement of more than 30%, each determined from baseline to 3 months after injection. In addition, two safety criteria also had to be met; a dose failed if (1) any reported event was determined to be related to the onabotulinum toxin A injection and was considered life threatening, disabling, or fatal or (2) \>=40% of the participants reported a moderate or severe side effect related to the botulinum toxin injection.

    12 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

100 units botulinum toxin type A (BoNT/A)

Drug: botulinum toxin type A (BoNT/A)

2

ACTIVE COMPARATOR

300 units botulinum toxin type A (BoNT/A)

Drug: botulinum toxin type A (BoNT/A)

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.

Also known as: marketed in the US as BOTOX by Allergan
12

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male at least 50 years of age.
  • Voided volume =\> 125 ml.
  • Maximum urinary flow \< 15 ml/sec.
  • AUA symptom severity score =\> 8.
  • Patient signed informed consent prior to the performance of any study procedures.
  • Patient able to complete the study protocol in the opinion of the investigator.

You may not qualify if:

  • Any prior surgical intervention for BPH.
  • Current diagnosis of acute or chronic prostatitis (which may cause LUTS that mimic BPH).
  • Overactive bladder without bladder outlet obstruction.
  • Enrolled in another treatment trial for any disease within the past 30 days.
  • Men interested in future fertility.
  • Previous exposure to botulinum toxin.
  • On alpha-blocker within the past 48 hours.
  • On any 5-alpha-reductase inhibitor within the past month.
  • Post void residual \> 350 ml.
  • On phenylephrine, pseudoephedrine, imipramine, an anticholinergic, or cholinergic medication within the past 2 weeks.
  • On estrogen, androgen, any drug producing androgen suppression, or anabolic steroids within the past 4 months.
  • Clinically significant renal or hepatic impairment as determined by abnormal creatinine or AST levels (based on local institutional values).
  • Serum prostate specific antigen level \> 8 ng/ml (Hybritech). For those with a PSA between 4-8 ng/ml, the PSA elevation must be considered to be from a benign cause in the opinion of the PI. This decision can be based on PSA velocity, previous TRUS biopsy, percent free PSA, or other clinical estimations in keeping with sound urologic care.
  • Active urinary tract disease or biopsy of the prostate within the past 6 weeks.
  • Daily use of a pad or device for incontinence required.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Colorado Health Sciences Center

Denver, Colorado, 80010, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Cornell University

New York, New York, 10021, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

  • Crawford ED, Hirst K, Kusek JW, Donnell RF, Kaplan SA, McVary KT, Mynderse LA, Roehrborn CG, Smith CP, Bruskewitz R. Effects of 100 and 300 units of onabotulinum toxin A on lower urinary tract symptoms of benign prostatic hyperplasia: a phase II randomized clinical trial. J Urol. 2011 Sep;186(3):965-70. doi: 10.1016/j.juro.2011.04.062. Epub 2011 Jul 24.

    PMID: 21791356RESULT

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Botulinum Toxins, Type AincobotulinumtoxinA

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Limitations and Caveats

First, this study was not designed to compare the effect of onabotulinum toxin A to placebo. Second, we assessed our primary outcome, treatment efficacy, at 3 months post-injection. The long-term safety of this product should also be evaluated.

Results Point of Contact

Title
Kathryn Hirst, PhD, Research Professor, PI of coordinating center
Organization
George Washington University Biostatistics Center
khirst@bsc.gwu.edu
301-881-9260

Study Officials

  • Reginald Bruskewitz, MD

    University of Wisconsin, Madison

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2007

First Posted

March 23, 2007

Study Start

October 1, 2006

Primary Completion

June 1, 2009

Study Completion

December 1, 2009

Last Updated

April 21, 2020

Results First Posted

June 24, 2013

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

Data are available at the NIDDK Central Repository https://repository.niddk.nih.gov/studies/mist2/?query=mist

More information

Locations

US(7)