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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

315 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-01

Study Completion Date

2012-06-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Benign Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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botulinum toxin Type A

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

Group Type EXPERIMENTAL

botulinum toxin Type A

Intervention Type DRUG

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

Placebo (Normal saline)

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

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

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

Interventions

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botulinum toxin Type A

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

Intervention Type DRUG

Normal saline

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

Intervention Type DRUG

Other Intervention Names

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BOTOX® onabotulinumtoxinA

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No