Safety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary Symptoms Due to Benign Prostatic Hyperplasia
This study has been completed.
Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00284518
First received: January 31, 2006
Last updated: November 16, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Benign Prostatic Hyperplasia |
Biological: botulinum toxin Type A Drug: normal saline |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Allergan:
Primary Outcome Measures:
- Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.
Secondary Outcome Measures:
- Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72 [ Time Frame: Baseline, Week 72 ] [ Designated as safety issue: No ]The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consists of seven items. The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms). A negative change from baseline indicates improvement.
- Change From Baseline in Peak Urine Flow Rate [ Time Frame: Baseline, Week 12, Week 72 ] [ Designated as safety issue: No ]Urinary flow was determined by uroflowmetry at baseline and various time-points during the study. An increase from baseline indicates improvement.
- Change From Baseline in Total Prostate Volume [ Time Frame: Baseline, Week 12, Week 72 ] [ Designated as safety issue: No ]Measurement of the prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.
- Change From Baseline in Transitional Zone Prostate Volume [ Time Frame: Baseline, Week 12, Week 72 ] [ Designated as safety issue: No ]Measurement of the transitional zone prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study. The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523. A negative change from baseline indicates improvement.
- Change From Baseline in Post-Void Residual [ Time Frame: Baseline, Week 2, Week 12, Week 72 ] [ Designated as safety issue: No ]Post-void residual urine volume was assessed by bladder scan or ultrasound on all participants at baseline and various time-points during the study. After voiding, any residual urine volume in the bladder was measured. A negative change from baseline indicates improvement.
Other Outcome Measures:
- Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain [ Time Frame: Baseline, Week 12, Week 72 ] [ Designated as safety issue: No ]The IIEF is a 15-item questionnaire filled out by the patient to assess erectile function over the past 4 weeks that contains five domains. The score for the erectile function domain is the sum of scores for Questions 1, 2, 3, 4, 5 and 15 for a total possible score of 1 to 30. A higher score indicates a better outcome. A positive change from baseline indicates improvement.
| Enrollment: | 380 |
| Study Start Date: | December 2005 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: botulinum toxin Type A 300 U
Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
|
Biological: botulinum toxin Type A
Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.
Other Name: BOTOX®
|
|
Experimental: botulinum toxin Type A 200 U
Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
|
Biological: botulinum toxin Type A
Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.
Other Name: BOTOX®
|
|
Experimental: botulinum toxin Type A 100 U
Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
|
Biological: botulinum toxin Type A
Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.
Other Name: BOTOX®
|
|
Placebo Comparator: Placebo (Normal Saline)
Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
|
Drug: normal saline
Normal Saline (Placebo) transperineal or transrectal injection on Day 1.
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00284518
Locations
| Australia | |
| Murdoch, Australia | |
| Austria | |
| Vienna, Austria | |
| Canada, British Columbia | |
| Victoria, British Columbia, Canada | |
| Czech Republic | |
| Olomouc, Czech Republic | |
| France | |
| Paris Cedex 13, France | |
| Germany | |
| Braunschweig, Germany | |
| Italy | |
| Perugia, Italy | |
| Korea, Republic of | |
| Seoul, Korea, Republic of | |
| Slovakia | |
| Martin, Slovakia | |
| Taiwan | |
| Taipei, Taiwan | |
| United Kingdom | |
| London, United Kingdom | |
Sponsors and Collaborators
Allergan
Investigators
| Study Director: | Medical Director | Allergan |
More Information
No publications provided by Allergan
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Allergan |
| ClinicalTrials.gov Identifier: | NCT00284518 History of Changes |
| Other Study ID Numbers: | 191622-517 |
| Study First Received: | January 31, 2006 |
| Results First Received: | November 16, 2012 |
| Last Updated: | November 16, 2012 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Prostatic Hyperplasia Hyperplasia Prostatic Diseases Genital Diseases, Male Pathologic Processes Botulinum Toxins, Type A Botulinum Toxins |
Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013