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

Condition(s) targeted: Benign Prostatic Hyperplasia

Intervention: botulinum toxin Type A (Biological); botulinum toxin Type A (Biological); botulinum toxin Type A (Biological); Placebo (Biological)

Phase: Phase 2

Status: Recruiting

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan

Overall contact:
Allergan Inc, Email: clinicaltrials@allergan.com

The purpose of this study is 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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: International Prostate Symptom Score

Secondary outcome:

Peak urine flow rate

Post Void Residual

Quality of Life questionnaires

Sexual Function questionnaire

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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

Allergan Inc, Email: clinicaltrials@allergan.com

Murdoch, Australia; Recruiting

Vienna, Austria; Recruiting

Olomouc, Czech Republic; Recruiting

Paris Cedex 13, France; Recruiting

Braunschweig, Germany; Recruiting

Perugia, Italy; Recruiting

Seoul, Korea, Republic of; Recruiting

Martin, Slovakia; Recruiting

Taipei, Taiwan; Recruiting

London, United Kingdom; Not yet recruiting

Victoria, British Columbia, Canada; Recruiting

Starting date: December 2005
Ending date: June 2011
Last updated: November 14, 2008