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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: March 14, 2013
Last verified: March 2013
History of Changes
  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:

MedlinePlus related topics: Botox
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Severity of Benign Prostatic Hyperplasia (BPH) symptoms as measured by the International Prostate Symptom Score questionnaire [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peak Urinary Flow Rate [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

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 200 U equally divided and administered to each lateral prostatic lobe
 Drug: botulinum toxin type A
botulinum toxin type A total dose of 200 U equally divided and administered to each lateral prostatic lobe
Other Name: BOTOX®
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
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
Last Updated: March 14, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 22, 2013