Back to resultsH-22411: BOTOX® for Peyronie's Disease
Primary Purpose
Peyronie's Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
100 units of Botulinum Toxin Type A
Preservative free normal saline
100 units Botulinum Toxin A
Sponsored by
About this trial
This is an interventional treatment trial for Peyronie's Disease
Eligibility Criteria
Inclusion Criteria:
- Subjects with stable Peyronie's plaques.
- Males at least 18 years of age
- Must give informed consent.
Exclusion Criteria:
- Subjects in the active phase of Peyronie's disease.
- Subjects with less than 1 year history of Peyronie's disease.
- Subjects taking oral medications for Peyronie's disease which include Trental, Viagra, vitamin E, colchicines, L-arginine, and tamoxifen. There will be a 2 week wash-out period if patients are on these medications.
- Subjects with more than 1 penile plaque will be excluded from the study.
- Subjects with calcified plaques demonstrated by ultrasound will be excluded from the study.
- Known allergy or sensitivity to any components of the study medication (botulinum toxin A), anesthetics, or any other product associated with the treatment and general study procedures.
- Any medical condition or neuromuscular disorder that may put the patient at increased risk with exposure to botulinum toxin A (BTX-A), including myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis.
- Patient taking aminoglycosides or any drug known to interfere with neuromuscular transmission.
- Patient has hemophilia or other clotting factor deficiencies or disorders that cause bleeding diathesis.
- Patient must not be taking aspirin, non-steroidal anti-inflammatory drugs, or Coumadin for 7 or more days prior to Botox injection.
- Episode of unstable angina pectoris, myocardial infarction, transient ischemic attack, or cerebrovascular accident within the past 6 months.
Sites / Locations
- Baylor College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
100 units of Botulinum Toxin Type A
Normal saline
Arm Description
Injection solution will consist of 100 units of BOTOX® in 10 cc of preservative free normal saline
Injection solution will consist of 10 cc preservative free normal saline Subjects had the choice of crossing over to ARM 1 at the end of 16 weeks. Cross-over: For subjects in Arm 2, crossover to BOTOX treatment will begin after the Week 16 Visit by repeating the study schedule as for Week 0 to Week 16.
Outcomes
Primary Outcome Measures
Average Percent Change of Penile Curvature in Degrees
Measured by a protractor from pictures taken at baseline (pre-treatment screening visit) and end of treatment at week 16
*Crossover subjects were added to Experimental Group for analysis*
Negative value equates to a reduction in curvature Positive value equates to an increase in curvature
Secondary Outcome Measures
Change in Penile Blood Flow for Peak Systolic Velocity (PSV) and End-diastolic Velocity (EDV)
Results of penile doppler ultrasound from baseline/screening visit to end of treatment at week 16 will be compared.
peak systolic velocity (PSV) and end-diastolic velocity (EDV) are assessed here.
Change is calculated as week 16 values - screening visit values
Negative values are a decrease in velocity Positive values are an increase in velocity
Change in Penile Blood Flow for Diameter
Results of penile doppler ultrasound from the baseline/screening visit to end of treatment at week 16 will be compared.
Diameter is assessed here.
Change is calculated as week 16 values - screening visit values
Negative values are a decrease in diameter Positive values are an increase in diameter
Change in Penile Plaque Size
Results of ultrasound at baseline/screening visit to end of treatment at week 16 will be compared.
*Crossover subjects were added to Experimental Group for analysis*
Change is calculated as week 16 values values minus screening visit values
Increase in value equates to increased plaque size Decrease in value equates to decreased plaque size
Changes in International Index of Erectile Function Scores (IIEF)
Subject's average scores on IIEF at baseline/screening visit to end of treatment at week 16 are compared
The subscale measures self-reported erectile function. Maximum score is 30, Minimum is 0. A score of 0 is the absolute best outcome. A score of 30 is the absolute worst outcome. Erectile Function score is a summation of questions 1,2,3,4, and 15. This study is assessing their erectile function and not the other subscales.
The other subscale scores are :
Orgasmic Function (Questions 9, 10); Maximum score = 10, Minimum score = 0
Sexual Desire (Questions 11, 12); Maximum score = 10, Minimum score = 0
Intercourse Satisfaction (Questions 6, 7, 8); Maximum score = 15, Minimum score = 0
Overall Satisfaction (Question 13, 14): Maximum score = 10, Minimum score = 0
Subscales are not combined to make a total composite score.
*Crossover subjects were added to Experimental Group for analysis*
Full Information
NCT ID
NCT00812838
First Posted
December 18, 2008
Last Updated
February 3, 2020
Sponsor
Mohit Khera
Collaborators
Allergan
1. Study Identification
Unique Protocol Identification Number
NCT00812838
Brief Title
H-22411: BOTOX® for Peyronie's Disease
Official Title
The Efficacy of Botulinum Toxin Type a in Treating Peyronie's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 7, 2009 (Actual)
Primary Completion Date
February 15, 2017 (Actual)
Study Completion Date
January 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohit Khera
Collaborators
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Peyronie's disease is a condition in which a plaque, or hard lump, forms on the penis. It causes hardened tissue, pain, and an abnormal bending in the penis. These symptoms are more severe during an erection. Significant bending of the penis can result in pain, poor erections, and an inability to engage in sexual intercourse.
This disease affects about 3% of the male population. The average age of onset of this disease is 57 years old. The cause of the disease is unknown. However, many believe that it may be due to trauma to the penis (such as injury or extremely vigorous sexual activity).
Detailed Description
Treatments for this disease have been limited and often unsuccessful. The goal of treatment is to reduce pain and maintain sexual function. Oral medicines that prevent plaque formation and promote plaque breakdown have not been effective. Many patients with the disease will require injections of medicines directly into the plaque. These injections have been used for over 50 years in the treatment of major Peyronie's disease. The disease often resolves on its own without treatment. Surgery may be performed to remove hardened tissue in the penis. However, surgery is not done during the first 12 months of the disease.
There are 2 phases of the disease: the active phase and the inactive phase. The active phase usually occurs during the first 12 months of the disease. The stabilization of the plaque is known as the inactive phase. We are inviting men with stable disease to take part in this study which will test BOTOX® versus a placebo (a placebo contains no medicine).
This will be a randomized, placebo-controlled, cross-over, single-center trial. The placebo group has the option to cross over to the treatment arm (ARM 1) of the study at the end of their 16 weeks of placebo arm (ARM 2). Study drug is Botulinum toxin type A (BOTOX®). Subjects who meet the inclusion criteria for the study will be randomized to either the treatment or placebo arm.
Treatment: Injection solution will consist of 100 units of BOTOX® in 10 cc of preservative free normal saline, or
Placebo: Injection solution will consist of 10 cc preservative free normal saline.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peyronie's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
100 units of Botulinum Toxin Type A
Arm Type
Experimental
Arm Description
Injection solution will consist of 100 units of BOTOX® in 10 cc of preservative free normal saline
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
Injection solution will consist of 10 cc preservative free normal saline
Subjects had the choice of crossing over to ARM 1 at the end of 16 weeks.
Cross-over: For subjects in Arm 2, crossover to BOTOX treatment will begin after the Week 16 Visit by repeating the study schedule as for Week 0 to Week 16.
Intervention Type
Drug
Intervention Name(s)
100 units of Botulinum Toxin Type A
Other Intervention Name(s)
BOTOX®
Intervention Description
Approximately 20 to 30 injections of 100 units of BOTOX® given with a 20 gage needle directly into the penile plaque
Intervention Type
Other
Intervention Name(s)
Preservative free normal saline
Intervention Description
Approximately 20 to 30 injections of 10cc of preservative free normal saline given with a 20 gage needle directly into the penile plaque
Intervention Type
Drug
Intervention Name(s)
100 units Botulinum Toxin A
Other Intervention Name(s)
Cross-over
Intervention Description
Approximately 20 to 30 injections of 100 units of BOTOX® given with a 20 gage needle directly into the penile plaque
Primary Outcome Measure Information:
Title
Average Percent Change of Penile Curvature in Degrees
Description
Measured by a protractor from pictures taken at baseline (pre-treatment screening visit) and end of treatment at week 16
*Crossover subjects were added to Experimental Group for analysis*
Negative value equates to a reduction in curvature Positive value equates to an increase in curvature
Time Frame
Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16
Secondary Outcome Measure Information:
Title
Change in Penile Blood Flow for Peak Systolic Velocity (PSV) and End-diastolic Velocity (EDV)
Description
Results of penile doppler ultrasound from baseline/screening visit to end of treatment at week 16 will be compared.
peak systolic velocity (PSV) and end-diastolic velocity (EDV) are assessed here.
Change is calculated as week 16 values - screening visit values
Negative values are a decrease in velocity Positive values are an increase in velocity
Time Frame
Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16
Title
Change in Penile Blood Flow for Diameter
Description
Results of penile doppler ultrasound from the baseline/screening visit to end of treatment at week 16 will be compared.
Diameter is assessed here.
Change is calculated as week 16 values - screening visit values
Negative values are a decrease in diameter Positive values are an increase in diameter
Time Frame
Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16
Title
Change in Penile Plaque Size
Description
Results of ultrasound at baseline/screening visit to end of treatment at week 16 will be compared.
*Crossover subjects were added to Experimental Group for analysis*
Change is calculated as week 16 values values minus screening visit values
Increase in value equates to increased plaque size Decrease in value equates to decreased plaque size
Time Frame
Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16
Title
Changes in International Index of Erectile Function Scores (IIEF)
Description
Subject's average scores on IIEF at baseline/screening visit to end of treatment at week 16 are compared
The subscale measures self-reported erectile function. Maximum score is 30, Minimum is 0. A score of 0 is the absolute best outcome. A score of 30 is the absolute worst outcome. Erectile Function score is a summation of questions 1,2,3,4, and 15. This study is assessing their erectile function and not the other subscales.
The other subscale scores are :
Orgasmic Function (Questions 9, 10); Maximum score = 10, Minimum score = 0
Sexual Desire (Questions 11, 12); Maximum score = 10, Minimum score = 0
Intercourse Satisfaction (Questions 6, 7, 8); Maximum score = 15, Minimum score = 0
Overall Satisfaction (Question 13, 14): Maximum score = 10, Minimum score = 0
Subscales are not combined to make a total composite score.
*Crossover subjects were added to Experimental Group for analysis*
Time Frame
Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with stable Peyronie's plaques.
Males at least 18 years of age
Must give informed consent.
Exclusion Criteria:
Subjects in the active phase of Peyronie's disease.
Subjects with less than 1 year history of Peyronie's disease.
Subjects taking oral medications for Peyronie's disease which include Trental, Viagra, vitamin E, colchicines, L-arginine, and tamoxifen. There will be a 2 week wash-out period if patients are on these medications.
Subjects with more than 1 penile plaque will be excluded from the study.
Subjects with calcified plaques demonstrated by ultrasound will be excluded from the study.
Known allergy or sensitivity to any components of the study medication (botulinum toxin A), anesthetics, or any other product associated with the treatment and general study procedures.
Any medical condition or neuromuscular disorder that may put the patient at increased risk with exposure to botulinum toxin A (BTX-A), including myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis.
Patient taking aminoglycosides or any drug known to interfere with neuromuscular transmission.
Patient has hemophilia or other clotting factor deficiencies or disorders that cause bleeding diathesis.
Patient must not be taking aspirin, non-steroidal anti-inflammatory drugs, or Coumadin for 7 or more days prior to Botox injection.
Episode of unstable angina pectoris, myocardial infarction, transient ischemic attack, or cerebrovascular accident within the past 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohit Khera, MD, MBA
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be published in aggregate.
Citations:
PubMed Identifier
15247734
Citation
Khera M, Boone TB, Smith CP. Botulinum toxin type A: a novel approach to the treatment of recurrent urethral strictures. J Urol. 2004 Aug;172(2):574-5. doi: 10.1097/01.ju.0000130652.27541.22. No abstract available.
Results Reference
background
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H-22411: BOTOX® for Peyronie's Disease
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