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

Allergan

Status and phase: Completed; Phase 2

Conditions: Benign Prostatic Hyperplasia

Treatments: Biological: botulinum toxin Type A; Drug: normal saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00284518

191622-517

Details and patient eligibility

About

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.

Enrollment: 380 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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380 participants in 4 patient groups, including a placebo group

botulinum toxin Type A 300 U

Experimental group

Description:

Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.

Treatment:

Biological: botulinum toxin Type A

botulinum toxin Type A 200 U

Experimental group

Description:

Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.

Treatment:

Biological: botulinum toxin Type A

botulinum toxin Type A 100 U

Experimental group

Description:

Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.

Treatment:

Biological: botulinum toxin Type A

Placebo (Normal Saline)

Placebo Comparator group

Description:

Placebo (Normal Saline) transperineal or transrectal injection on Day 1.

Treatment:

Drug: normal saline