Skip to main content
OpenTrials
Completed

NCT Number: NCT00284518

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Murdoch, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Botulinum toxin type A

Biological

Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.

Other names: BOTOX®

normal saline

Drug

Normal Saline (Placebo) transperineal or transrectal injection on Day 1.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2005
Primary completion
2009
Study completion
2010
First posted
Feb 1, 2006
Registry last updated
Dec 17, 2012

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.