Intracavernosal Injection of Botulinum Toxin Type A (50 and 100 Unit) in the Treatment of Erectile Dysfunction
Primary Purpose
Erectile Dysfunction, Botulinum Toxin
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
saline injection
Botulinum toxin type A 50 units
Botulinum toxin type A 100 units
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction
Eligibility Criteria
Inclusion Criteria:
- Age between 40 to 70 years. Vascular ED proved by penile duplex. Unable to develop erections sufficient for intercourse. A "No" response on Sexual encounter profile questions (SEP 2 & 3) Failing to respond to first line and second line treatments for Erectile Dysfunction with surgery as the only remaining treatment option.
Exclusion Criteria:
- Significant cardiovascular disease interfering with sexual activity Any history of an unstable medical or psychiatric condition Any presence of penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair erectile function.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Group C
Arm Description
The control group: received an IC 1 ml saline injection one day after the penile Doppler/trimix test.
The treatment group B: received a single IC injection of BTX-A 50 units one day after the penile Doppler/trimix test.
The treatment group C: intervention: received a single IC injection of BTX-A 100 units one day after the penile Doppler/trimix test.
Outcomes
Primary Outcome Measures
Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF)
Changes in the Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) between treatment periods and baseline in different study arms. the score as follow:
> 7 severe dysfunction 7-12 Moderate dysfunction
13-18 Mild to moderate dysfunction
19-24 Mild dysfunction
25-30 No dysfunction
the Sexual Event Profile (SEP) scores
Changes in the Sexual Event Profile (SEP) scores between treatment periods and baseline in different study arms by a <yes or no> response .
Global Assessment Questionnaire (GAQ) scores
Changes in the Global Assessment Questionnaire (GAQ) scores between treatment periods in different study arms by a <yes or no> response
Cavernosal artery peak systolic and end diastolic velocities
Change in Peak systolic velocity in the Cavernosal arteries, on color Doppler examination, in the patient and control groups.
Secondary Outcome Measures
Full Information
NCT ID
NCT03355963
First Posted
November 13, 2017
Last Updated
November 24, 2019
Sponsor
Benha University
Collaborators
Cairo University
1. Study Identification
Unique Protocol Identification Number
NCT03355963
Brief Title
Intracavernosal Injection of Botulinum Toxin Type A (50 and 100 Unit) in the Treatment of Erectile Dysfunction
Official Title
Comparative Study Between Intracavernosal Injection of Botulinum Toxin Type A (50 and 100 Unit) Efficacy and Durability in the Treatment of Vascular Erectile Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 12, 2016 (Actual)
Primary Completion Date
January 25, 2019 (Actual)
Study Completion Date
February 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
Collaborators
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
purpose: The aim of this study is to compare the safety, efficacy and durability of different doses of BTX-A (50 and 100 unit) in the treatment of Vasculogenic Erectile Dysfunction after failure of other ICI therapy.
Patients and Methods: This study will be conducted on 200 patients diagnosed as vascular erectile dysfunction by penile color Doppler not responding to medical and injection therapy presenting to Urology department and outpatient clinic at Benha University Hospital, Andrology, Sexology & STD's outpatient clinic, Kasr El Aini Hospitals, Cairo University.(multicentric study).
A- Inclusion criteria:
Age between 40 to 70 years.
Vascular ED proved by penile duplex.
Unable to develop erections sufficient for intercourse.
A "No" response on Sexual encounter profile questions (SEP 2 & 3)
Failing to respond to first line and second line treatments for Erectile Dysfunction with surgery as the only remaining treatment option.
B-Exclusion criteria:
Significant cardiovascular disease interfering with sexual activity
Any history of an unstable medical or psychiatric condition
Any presence of penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair erectile function.
patients will be simply randomized into 3 equal groups, one control group and two treatment groups. Ethics committee approval and informed consent were obtained.
Detailed Description
introduction: Evidence has been arising suggesting that Botulinum toxin type A (BTX-A) injections can relax smooth muscles fibers in the treatment of obesity and Detrusor muscle over-activity, similar effect on cavernosal smooth muscles would help in the treatment of erectile dysfunction (ED) resistant to oral and intracavernous (IC) therapy, thus avoiding surgical treatment options.
patient and methods: All patients will perform penile color Doppler evaluation to confirm a vascular etiology, a trimix solution (PGE1 10 ug + Phentolamine 1 mg + Papaverine 30 mg) was injected IC during the penile Doppler study.
The control group: received an IC 1 ml saline injection one day after the penile Doppler/trimix test.
The treatment group B: received a single IC injection of BTX-A 50 units one day after the penile Doppler/trimix test.
The treatment group C: received a single IC injection of BTX-A 100 units one day after the penile Doppler/trimix test.
Assessment for all groups was done by penile color Doppler exam, Sexual Health Inventory for men (SHIM), Sexual Encounter Profile questions 2 and 3 (SEP 2 & SEP 3), and the global assessment question (GAQ) were completed pre-treatment and 2 weeks after treatment also, 3 and 6 months after treatment.
Procedure:
At least 1 day after the penile color Doppler test, the patient is placed in the supine position flaccid and stretched penile length and girth would be measured from tip of the penis to the pubic bone will be done. A rubber band will be applied to the base of the penis. The skin will be prepped with alcohol swabs followed by the IC injection of 50 units of BTX-A for patients in treatment group B and 100 units of BTX-A for patients in treatment group C with direct pressure will be applied for 2 minutes. The rubber band will be removed after 15 minutes.
Patients and controls will fill the Sexual Health Inventory for men (SHIM) questionnaire and answer the ,Sexual Encounter Profile questions 2 and 3 (SEP 2 & SEP 3), and the global assessment question (GAQ) before and 2 weeks, 3 months and 6 months after treatment .
The rational for selecting the minimum 2-weeks waiting period is to give a chance for the BTX-A to reach its maximum effect. Possible Risks include pain and prolonged erections, also 3 months and 6 months after treatment do detect safety, efficacy and durability.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction, Botulinum Toxin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Placebo Comparator
Arm Description
The control group: received an IC 1 ml saline injection one day after the penile Doppler/trimix test.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
The treatment group B: received a single IC injection of BTX-A 50 units one day after the penile Doppler/trimix test.
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
The treatment group C:
intervention: received a single IC injection of BTX-A 100 units one day after the penile Doppler/trimix test.
Intervention Type
Other
Intervention Name(s)
saline injection
Other Intervention Name(s)
group A (control group)
Intervention Description
The control group: received an IC 1 ml saline injection one day after the penile Doppler/trimix test.
Intervention Type
Biological
Intervention Name(s)
Botulinum toxin type A 50 units
Other Intervention Name(s)
group B
Intervention Description
The treatment group B: received a single IC injection of BTX-A 50 units one day after the penile Doppler/trimix test.
Intervention Type
Biological
Intervention Name(s)
Botulinum toxin type A 100 units
Other Intervention Name(s)
group C
Intervention Description
The treatment group C: received a single IC injection of BTX-A 100 units one day after the penile Doppler/trimix test.
Primary Outcome Measure Information:
Title
Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF)
Description
Changes in the Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) between treatment periods and baseline in different study arms. the score as follow:
> 7 severe dysfunction 7-12 Moderate dysfunction
13-18 Mild to moderate dysfunction
19-24 Mild dysfunction
25-30 No dysfunction
Time Frame
pre-treatment and 2 weeks after treatment also, 3 and 6 months after treatment
Title
the Sexual Event Profile (SEP) scores
Description
Changes in the Sexual Event Profile (SEP) scores between treatment periods and baseline in different study arms by a <yes or no> response .
Time Frame
baseline, 2 weeks post treatment , 3, and 6 months post treatment
Title
Global Assessment Questionnaire (GAQ) scores
Description
Changes in the Global Assessment Questionnaire (GAQ) scores between treatment periods in different study arms by a <yes or no> response
Time Frame
baseline, 2 weeks post treatment , 3, and 6 months post treatment
Title
Cavernosal artery peak systolic and end diastolic velocities
Description
Change in Peak systolic velocity in the Cavernosal arteries, on color Doppler examination, in the patient and control groups.
Time Frame
baseline, 2 weeks post treatment , 3, and 6 months post treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 40 to 70 years. Vascular ED proved by penile duplex. Unable to develop erections sufficient for intercourse. A "No" response on Sexual encounter profile questions (SEP 2 & 3) Failing to respond to first line and second line treatments for Erectile Dysfunction with surgery as the only remaining treatment option.
Exclusion Criteria:
Significant cardiovascular disease interfering with sexual activity Any history of an unstable medical or psychiatric condition Any presence of penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair erectile function.
12. IPD Sharing Statement
Learn more about this trial
Intracavernosal Injection of Botulinum Toxin Type A (50 and 100 Unit) in the Treatment of Erectile Dysfunction
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