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Completed

NCT Number: NCT01107392

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

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.

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Surrey, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum Toxin Type A

Drug

botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.

Other names: BOTOX®, onabotulinumtoxinA

normal saline

Drug

Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 21, 2010
Registry last updated
May 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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