Safety and Efficacy of Botulinum Toxin Type A to Treat Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

April 29, 2019 updated by: Allergan
This study will evaluate the safety and efficacy of intraprostatic administration of botulinum toxin Type A (BOTOX®) compared with placebo to treat urinary tract symptoms due to benign prostatic hyperplasia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

315

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Clinical enlargement of the prostate gland
  • Body weight ≥ 50 kg or 110 lbs

Exclusion Criteria:

  • History of chronic prostatitis
  • History of two or more urinary tract infections in the past year or one in the last 6 months
  • History of bladder stones
  • History of previous prostate surgery
  • History of bladder cancer or prostate cancer
  • Any previous or current usage of botulinum toxin therapy of any serotype for any urological condition
  • Botulinum toxin therapy of any serotype for any non-urological condition or usage (e.g., cosmetic) during the previous 12 weeks prior to study entry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: botulinum toxin Type A
botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
Drug: botulinum toxin Type A
botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
Other Names:
  • BOTOX®
  • onabotulinumtoxinA
Placebo Comparator: Placebo (Normal saline)
Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
Drug: Normal saline
Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Week 12
Time Frame: Baseline, Week 12
IPSS is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consisted of seven items. The patient evaluated their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score ranged from 0 (no symptoms) to 35 (most severe symptoms). A negative change from Baseline indicated improvement.
Baseline, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Total International Prostate Symptom Score (IPSS)
Time Frame: Baseline, Week 6, Week 24
IPSS is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consisted of seven items. The patient evaluated their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score ranged from 0 (no symptoms) to 35 (most severe symptoms). A negative change from Baseline indicated improvement.
Baseline, Week 6, Week 24
Change From Baseline in Peak Urine Flow Rate
Time Frame: Baseline, Weeks 6, 12 and 24
Urinary flow was determined by uroflowmetry measured in milliliters/second (mL/sec). An increase from Baseline indicated improvement.
Baseline, Weeks 6, 12 and 24
Duration of Effect
Time Frame: 24 Weeks
Duration of effect was calculated from the time of the first follow-up visit with a ≥ 4-point reduction from Baseline in IPSS to the next visit when the IPSS change from Baseline was < 4-points.
24 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2010

Primary Completion (Actual)

March 16, 2012

Study Completion (Actual)

June 8, 2012

Study Registration Dates

First Submitted

April 16, 2010

First Submitted That Met QC Criteria

April 19, 2010

First Posted (Estimate)

April 21, 2010

Study Record Updates

Last Update Posted (Actual)

May 3, 2019

Last Update Submitted That Met QC Criteria

April 29, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 191622-100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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