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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00284518
Recruitment Status : Completed
First Posted : February 1, 2006
Results First Posted : December 17, 2012
Last Update Posted : December 17, 2012
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
The purpose of this study was to determine the safety and effectiveness of different doses of botulinum toxin Type A in treating lower urinary tract symptoms due to benign prostatic hyperplasia.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Biological: botulinum toxin Type A Drug: normal saline Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : December 2005
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: botulinum toxin Type A 300 U
Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
 Biological: botulinum toxin Type A
Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.
Other Name: BOTOX®
Experimental: botulinum toxin Type A 200 U
Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
 Biological: botulinum toxin Type A
Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.
Other Name: BOTOX®
Experimental: botulinum toxin Type A 100 U
Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
 Biological: botulinum toxin Type A
Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.
Other Name: BOTOX®
Placebo Comparator: Placebo (Normal Saline)
Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
 Drug: normal saline
Normal Saline (Placebo) transperineal or transrectal injection on Day 1.


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12 [ Time Frame: Baseline, Week 12 ]
    The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.


Secondary Outcome Measures :
  1. Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72 [ Time Frame: Baseline, Week 72 ]
    The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.

  2. Change From Baseline in Peak Urine Flow Rate [ Time Frame: Baseline, Week 12, Week 72 ]
    Urinary flow was determined by uroflowmetry at baseline and various time-points during the study. An increase from baseline indicates improvement.

  3. Change From Baseline in Total Prostate Volume [ Time Frame: Baseline, Week 12, Week 72 ]
    Measurement of the prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.

  4. Change From Baseline in Transitional Zone Prostate Volume [ Time Frame: Baseline, Week 12, Week 72 ]
    Measurement of the transitional zone prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.

  5. Change From Baseline in Post-Void Residual [ Time Frame: Baseline, Week 2, Week 12, Week 72 ]
    Post-void residual urine volume was assessed by bladder scan or ultrasound on all participants at baseline and various time-points during the study. After voiding, any residual urine volume in the bladder was measured. A negative change from baseline indicates improvement.


Other Outcome Measures:
  1. Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain [ Time Frame: Baseline, Week 12, Week 72 ]
    The IIEF is a 15-item questionnaire filled out by the patient to assess erectile function over the past 4 weeks that contains five domains. The score for the erectile function domain is the sum of scores for Questions 1, 2, 3, 4, 5 and 15 for a total possible score of 1 to 30. A higher score indicates a better outcome. A positive change from baseline indicates improvement.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Lower urinary tract symptoms due to benign prostatic hyperplasia
  • Enlarged prostate volume by rectal ultrasound

Exclusion Criteria:

  • Previous prostate surgery
  • Previous or current diagnosis of prostate cancer
  • Use of other medications for the treatment of prostatic hyperplasia
  • Urinary tract infection
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284518


Locations
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Australia
Murdoch, Australia
Austria
Vienna, Austria
Canada, British Columbia
Victoria, British Columbia, Canada
Czech Republic
Olomouc, Czech Republic
France
Paris Cedex 13, France
Germany
Braunschweig, Germany
Italy
Perugia, Italy
Korea, Republic of
Seoul, Korea, Republic of
Slovakia
Martin, Slovakia
Taiwan
Taipei, Taiwan
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00284518    
Other Study ID Numbers: 191622-517
First Posted: February 1, 2006    Key Record Dates
Results First Posted: December 17, 2012
Last Update Posted: December 17, 2012
Last Verified: November 2012
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents