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

Benign Prostatic Hyperplasia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00284518
• Other study ID #: 191622-517
• Status: Completed
• Phase: Phase 2
• First received: January 31, 2006
• Last updated: November 16, 2012
• Start date: December 2005
• Est. completion date: May 2010

Study information

• Verified date: November 2012
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: May 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

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

Drug:
• normal saline
Normal Saline (Placebo) transperineal or transrectal injection on Day 1.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

Australia,  Austria,  Canada,  Czech Republic,  France,  Germany,  Italy,  Korea, Republic of,  Slovakia,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain	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.	Baseline, Week 12, Week 72	No
Primary	Change From Baseline in International Prostate Symptom Score (IPSS) at 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.	Baseline, Week 12	No
Secondary	Change From Baseline in International Prostate Symptom Score (IPSS) at 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.	Baseline, Week 72	No
Secondary	Change From Baseline in Peak Urine Flow Rate	Urinary flow was determined by uroflowmetry at baseline and various time-points during the study. An increase from baseline indicates improvement.	Baseline, Week 12, Week 72	No
Secondary	Change From Baseline in Total Prostate Volume	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.	Baseline, Week 12, Week 72	No
Secondary	Change From Baseline in Transitional Zone Prostate Volume	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.	Baseline, Week 12, Week 72	No
Secondary	Change From Baseline in Post-Void Residual	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.	Baseline, Week 2, Week 12, Week 72	No