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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
380
Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.
Normal Saline (Placebo) transperineal or transrectal injection on Day 1.
Unnamed facility
Murdoch, Australia
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Vienna, Austria
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Victoria, British Columbia, Canada
Unnamed facility
Olomouc, Czechia
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.
Time frame: Baseline, Week 12
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.
Time frame: Baseline, Week 72
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.
Time frame: Baseline, Week 12, Week 72
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.
Time frame: Baseline, Week 12, Week 72
Change From Baseline in Transitional Zone Prostate Volume
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Unnamed facility
Paris, France
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Braunschweig, Germany
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Perugia, Italy
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Martin, Slovakia
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Seoul, South Korea
Unnamed facility
Taipei, Taiwan
...and 1 more locations
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.
Time frame: Baseline, Week 12, Week 72
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.
Time frame: Baseline, Week 2, Week 12, Week 72