Evaluation of the effectiveness of Erectofix device in solving the problem of erectile dysfunction
Design
A randomized clinical trial (phase III) single-blind with control group, 28 patient in each group.
Randomization will be done with excel software
Settings and conduct
Patients who enter the study, complete the International Erectile function Questionnaire and randomly assigned to each group. In the intervention group, Higgs energy transfer is performed with the help of PVS (penile vibratory stimulation) embedded in the Erectofix device. This energy transfer is transmitted by both arms simultaneously to both the lower and upper levels of the penis and causes vibrational/vibratory stimulation to both the back and top of the penis, as well as to each branch of the pudendal nerve. All these steps are performed by a trained urologist and technician.
Both groups are not excluded from routine treatment. After the study, the questionnaire is completed again.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All men aged 30 to 55 with erectile dysfunction referring to the Urology Clinic of Shahada Tajrish Hospital
exclusion criteria:
History of urological surgery leading to area nerve rupture, area vascular damage, History of orchiectomy, History of penis trauma with venous arterial fistula, History of genital trauma with neurological or vascular defection., History of antipsychotic drugs and benzodiazepines, anti-androgens assumption, History of diseases (diabetes, hypertension, hyperlipidemia, thyroid disorders and severe depression), History of smoking, alcohol and drugs, history of occupational exposure to chemicals and radioactive substances.
Intervention groups
1- Treatment group with Erectofix device
2- Control group without any intervention (routine treatment)
Main outcome variables
Erectile dysfunction
General information
Reason for update
Acronym
مشکل اختلال در نعوظ
IRCT registration information
IRCT registration number:IRCT20111121008146N40
Registration date:2022-08-21, 1401/05/30
Registration timing:prospective
Last update:2022-08-21, 1401/05/30
Update count:0
Registration date
2022-08-21, 1401/05/30
Registrant information
Name
Mohammadreza Razaghi
Name of organization / entity
Laser application in medical sciences research center
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8021
Email address
laser.cntr@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-22, 1401/05/31
Expected recruitment end date
2023-08-22, 1402/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Erectofix device in the patients with erectile dysfunction
Public title
Evaluation of the effectiveness of Erectofix device for erectile dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20-55 years
Has an erectile dysfunction problem
Exclusion criteria:
History of urological surgery with area nerve rupture, area vascular damage
History of orchiectomy
History of penile trauma with venous arterial fistula
History of trauma to the genital area that has caused neurological or vascular defects in the area.
History of taking antipsychotic drugs and benzodiazepines, anti-androgens
History of medical conditions (diabetes, hypertension, hyperlipidemia, thyroid disorders and major depression)
History of smoking, alcohol and drugs, as well as a history of occupational exposure to chemicals and radioactive substances.
Age
From 30 years old to 55 years old
Gender
Male
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Using Excel software, we generate random numbers. Even numbers are assigned to the intervention group and odd numbers to the control group. The production of random numbers continues until the samples of each group are completed.
Blinding (investigator's opinion)
Single blinded
Blinding description
The statistical analyst will analyze the grouping of the data in the form of A and B and will not know which is the intervention group and which is the control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Organizational Committee of Ethics in Biomedical Research
Street address
Tehran - Shahid Chamran Highway Yemen Street - Shahid Arabi Street next to Ayatollah Taleghani Hospital
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-05-29, 1401/03/08
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.106
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
Erectile dysfunction
Timepoint
Before intervention and one week after the last intervention
Method of measurement
Male sexual function refers to the score that a person obtains in the International Male Erectile Performance Index Questionnaire (Rosen et al., 1997).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Higgs energy transfer is performed with penile vibratory stimulation embedded in the Erectofix device. This energy is transmitted by both arms simultaneously to the lower and upper levels of the penis and vibrational/vibratory stimulation to the back and top of the penis, as well as to each branch of the pudendal nerve. A trained urologist and technician perform all these steps. The waves of this device are RF and radio frequency waves. Of course, these waves do no harm to the body and have the highest compatibility with the body.