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

Benign Prostatic Hyperplasia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01107392
• Other study ID #: 191622-100
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2010
• Est. completion date: June 8, 2012

Study information

• Verified date: April 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: June 8, 2012
• Est. primary completion date: March 16, 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Drug:
• botulinum toxin Type A
botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
• Normal saline
Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  France,  Germany,  Korea, Republic of,  Philippines,  Poland, 

References & Publications (1)

McVary KT, Roehrborn CG, Chartier-Kastler E, Efros M, Bugarin D, Chen R, Patel A, Haag-Molkenteller C. A multicenter, randomized, double-blind, placebo controlled study of onabotulinumtoxinA 200 U to treat lower urinary tract symptoms in men with benign prostatic hyperplasia. J Urol. 2014 Jul;192(1):150-6. doi: 10.1016/j.juro.2014.02.004. Epub 2014 Feb 7. Erratum in: J Urol. 2015 Jan;193(1):374. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Total International Prostate Symptom Score (IPSS) at 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.	Baseline, Week 12
Secondary	Change From Baseline in the Total International Prostate Symptom Score (IPSS)	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.	Baseline, Week 6, Week 24
Secondary	Change From Baseline in Peak Urine Flow Rate	Urinary flow was determined by uroflowmetry measured in milliliters/second (mL/sec). An increase from Baseline indicated improvement.	Baseline, Weeks 6, 12 and 24
Secondary	Duration of Effect	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.	24 Weeks