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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01107392
First received: April 16, 2010
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Benign Prostatic Hyperplasia
Drug: botulinum toxin Type A
Drug: Normal saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change From Baseline in the Total International Prostate Symptom Score (IPSS) [ Time Frame: Baseline, Week 6, Week 24 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Peak Urine Flow Rate [ Time Frame: Baseline, Weeks 6, 12 and 24 ] [ Designated as safety issue: No ]
    Urinary flow was determined by uroflowmetry measured in milliliters/second (mL/sec). An increase from Baseline indicated improvement.

  • Duration of Effect [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 315
Study Start Date: August 2010
Study Completion Date: June 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01107392

Locations
United States, California
Newport Beach, California, United States
Canada, British Columbia
Surrey, British Columbia, Canada
Czech Republic
Praha, Czech Republic
France
Paris, France
Germany
Munich, Germany
Korea, Republic of
Seoul, Korea, Republic of
Philippines
Manila, Philippines
Poland
Poznan, Poland
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01107392     History of Changes
Other Study ID Numbers: 191622-100
Study First Received: April 16, 2010
Results First Received: February 24, 2014
Last Updated: February 24, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hyperplasia
Lower Urinary Tract Symptoms
Prostatic Hyperplasia
Genital Diseases, Male
Pathologic Processes
Prostatic Diseases
Signs and Symptoms
Urological Manifestations
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014