Eficacy of Intracavernosal Injections of 50 units versus 100 units Abo botulinum toxinA (Dysport®) in vasculogenic Erectile Dysfunction with Phosphosdiesterase Type 5 Inhibitors resistant
Eficacy of Intracavernosal Injections of 50 units versus 100 units Abo botulinum toxinA (Dysport®) in vasculogenic Erectile Dysfunction with Phosphosdiesterase Type 5 Inhibitors resistant
Design
Clinical trial without control group with two parallel group, blinded outcomes assessment, with simple randomization, design for 20 patients, phase 2-3.
Settings and conduct
In this study, out patients who refer to Imam Khomeini hospital in Ahvaz that were qualified for this study got comforted with IIEF, SHIM score, Erection hardness score and Doppler Sonography with Papaverine injection. Then patients were divided into two groups. One group was treated with a single dose of 50 units Dysport and the other group was treated with a single dose of 100 units. Only the person who injected the drug knows the dosage of Dysport while sonographist, person who have collected the data and patients don't know about the dosage.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 40 to 70 years of age, erectile dysfunction confirmed with colour Doppler sonography and failure to response to first line treatments.
exclusion criteria: cardiovascular diseases that interfere with erectile function,unstable physical and psychological situations,anatomical abnormality of penis,hormonal disorder and history of spinal cord surgery or radical pelvic surgery.
Intervention groups
Patients with 5 phosphodiesterase inhibitor resistant Vasculogenic erectile dysfunction (arterial insufficiency) confirmed by Doppler Sonography with Papaverine injection
Main outcome variables
In this study, we evaluate the success rate of this method in patient with first lines resistant erectile dysfunction and based on the results of this study we can use new and safe line for these patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201119049439N1
Registration date:2020-12-10, 1399/09/20
Registration timing:prospective
Last update:2020-12-10, 1399/09/20
Update count:0
Registration date
2020-12-10, 1399/09/20
Registrant information
Name
sajad moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3292 3985
Email address
sajadsamyar1365@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
2020-12-21, 1399/10/01
Actual recruitment end date
2021-04-21, 1400/02/01
Trial completion date
2021-04-21, 1400/02/01
Scientific title
Eficacy of Intracavernosal Injections of 50 units versus 100 units Abo botulinum toxinA (Dysport®) in vasculogenic Erectile Dysfunction with Phosphosdiesterase Type 5 Inhibitors resistant
Public title
Efficacy of Dysport on erectile dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
40 to 70 years of age
Erectile Dysfunction proved by colour doppler sonography
Failure to response to first lines treatments
Exclusion criteria:
significant cardiovascular diseases that interfere with erectile function
History of unstable physical and psychological situations
Anatomical abnormalities of the penis
Hormonal disorders
History of spinal cord or pelvic radical surgery
Age
From 40 years old to 70 years old
Gender
Male
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
Randomized
Randomization description
In this study randomization performed with simple randomization, personal,with statistical software usage.
Blinding (investigator's opinion)
Double blinded
Blinding description
Only drug injector knows the drug dosage. Sonographist, the person who collects the data and the patient don't know the dosage.
Placebo
Not used
Assignment
Parallel
Other design features
Patients in two groups received the same intervention (drug injection) but with two different dosages.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan center of Ahvaz university of medical sciences
Street address
Imam Khomeini hospital, Azadegan street
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Approval date
2020-11-17, 1399/08/27
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1399.105
Health conditions studied
1
Description of health condition studied
Erectile dysfunction
ICD-10 code
N52.9
ICD-10 code description
Male erectile dysfunction, unspecified
Primary outcomes
1
Description
peak systolic velocity in cavernosal artery
Timepoint
Before and after Intracavernosal injection of 50 and 100 units Dysport
Method of measurement
Sonography
2
Description
end diastolic velocity in cavernosal artery
Timepoint
Before and after Intracavernosal injection of 50 and 100 units Dysport
Method of measurement
Sonography
3
Description
International Index of Erectile Function(IIEF)
Timepoint
Before and after Intracavernosal injection of 50 and 100 units Dysport
Method of measurement
Questionnaire
4
Description
Sexual Health Inventory for Men(SHIM SCORE)
Timepoint
Before and after Intracavernosal injection of 50 and 100 units Dysport
Method of measurement
Questionnaire
5
Description
Erection Hardness Score
Timepoint
Before and after Intracavernosal injection of 50 and 100 units Dysport
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group1: qualified patients that have vasculogenic erectile dysfunction confirmed by Doppler sonography will be affected with 50 units intracavernosal Dysport injection.
Category
Treatment - Drugs
2
Description
Intervention Group2: qualified patients that have vasculogenic erectile dysfunction confirmed by Doppler sonography will be affected with 100 units intracavernosal Dysport injection.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital in Ahvaz
Full name of responsible person
Dinyar Khazaeli
Street address
Azadegan street, Imam khomeini hospital
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2818
Email
himam@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dinyar Khazaeli
Street address
Ahvaz university of medical science in Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 1968
Email
fmedicine@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sajad Moradi
Position
Resident of urology
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
No. 68, second Left street, Phase 3 street, Melat alley.
City
Ahvaz
Province
Khouzestan
Postal code
6164883384
Phone
+98 61 3292 3985
Email
sajadsamyar1365@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dinyar khazaeli
Position
Urologist
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Azadegan street,Imam Khomeini hospital in
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2818
Email
Khazaeli_dinyar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sajad Moradi
Position
Resident of urology
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
No. 68, second Left street, Phase 3 street, Mellat alley.
City
Ahvaz
Province
Khouzestan
Postal code
6164883384
Phone
+98 61 3292 3985
Email
sajadsamyar1365@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after anonymising the patients.
When the data will become available and for how long
Access period will start after publishing the results.
To whom data/document is available
Everybody
Under which criteria data/document could be used
There is no barrier to access.
From where data/document is obtainable
Azadegan street, Imam Khomeini hospital . email: sajadsamyar1365@gmail.com. postal code:6193673111
What processes are involved for a request to access data/document