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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00284518
First received: January 31, 2006
Last updated: November 16, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Benign Prostatic Hyperplasia
Biological: 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, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72 [ Time Frame: Baseline, Week 72 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Peak Urine Flow Rate [ Time Frame: Baseline, Week 12, Week 72 ] [ Designated as safety issue: No ]
    Urinary flow was determined by uroflowmetry at baseline and various time-points during the study. An increase from baseline indicates improvement.

  • Change From Baseline in Total Prostate Volume [ Time Frame: Baseline, Week 12, Week 72 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Transitional Zone Prostate Volume [ Time Frame: Baseline, Week 12, Week 72 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Post-Void Residual [ Time Frame: Baseline, Week 2, Week 12, Week 72 ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain [ Time Frame: Baseline, Week 12, Week 72 ] [ Designated as safety issue: No ]
    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.


Enrollment: 380
Study Start Date: December 2005
Study Completion Date: May 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders 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
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: NCT00284518

Locations
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
Study Director: Medical Director Allergan
  More Information

No publications provided by Allergan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00284518     History of Changes
Other Study ID Numbers: 191622-517
Study First Received: January 31, 2006
Results First Received: November 16, 2012
Last Updated: November 16, 2012
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on September 22, 2014