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

NCT01107392 | Completed Phase 2 Results

• 1 other identifier: 191622-100
• Study Type: interventional
• Target: 315
• Locations: 8 countries
• Sites: 8

Brief 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.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change From Baseline in the Total International Prostate Symptom Score (IPSS)

  Baseline, Week 6, Week 24

• Change From Baseline in Peak Urine Flow Rate

  Baseline, Weeks 6, 12 and 24

• Duration of Effect

  24 Weeks

Study Arms (2)

botulinum toxin Type A

EXPERIMENTAL

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

Drug: botulinum toxin Type A

Placebo (Normal saline)

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

botulinum toxin Type A DRUG

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

Also known as: BOTOX®, onabotulinumtoxinA

botulinum toxin Type A

Normal saline DRUG

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

Placebo (Normal saline)

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical enlargement of the prostate gland
• Body weight ≥ 50 kg or 110 lbs

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (8)

Unknown Facility

Newport Beach, California, United States

Location

Unknown Facility

Surrey, British Columbia, Canada

Location

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Munich, Germany

Location

Unknown Facility

Manila, Philippines

Location

Unknown Facility

Poznan, Poland

Location

Unknown Facility

Seoul, South Korea

Location

Related 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.

  PMID: 24508634 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Botulinum Toxins, Type A; Saline Solution

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2010
• First Posted: April 21, 2010
• Study Start: August 1, 2010
• Primary Completion: March 16, 2012
• Study Completion: June 8, 2012
• Last Updated: May 3, 2019
• Results First Posted: April 4, 2014

Record last verified: 2019-04

Locations

PL (1); CA (1); PH (1); US (1); CZ (1); KR (1); FR (1); DE (1)