Evaluation of effectiveness of shock wave therapy in patients with erectile dysfunction
Design
Clinical trial without control group, without parallel group, without randomization on 50 patients.the outcome assessment was binded.
Settings and conduct
Patients will be recruited from the urology outpatient clilc of Emam Reza hospital.After providing a detailed explanation of the study aims and obtaining informed consent, eligible participants will be enrolled. The intervention will consist of one session per week of shockwave therapy for 6 weeks, with an energy flux density of 0.25 millijoules per square millimeter. Participants will then be followed up at 3 months post- treatment. The international index of erectile function (IIEF) questionnaire will be used to assess treatment response and evaluate changes in erectile function.
Participants/Inclusion and exclusion criteria
Inclusion criteria:All patients who dont be treated with maximum dose of PDEi drugs for 4 times
Exclusion criteria: Lack of consent to participate in the study and the presence of contraindications for performing shockwave therapy such as hemodynamic disturbances
Intervention groups
All patients with erectile dysfunction who dont be treated with PDEi drugs
Main outcome variables
1- improve orgasmic performance
2- improve libido
3- improve erectile function
4- improve sexual satisfaction
5- overall satisfaction of the individual
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230125057230N1
Registration date:2023-08-09, 1402/05/18
Registration timing:registered_while_recruiting
Last update:2023-08-09, 1402/05/18
Update count:0
Registration date
2023-08-09, 1402/05/18
Registrant information
Name
aida jamlou
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 2809
Email address
aidajamlou@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-13, 1401/12/22
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluation of the effectiveness of shock wave therapy in drag-resistant impotence
Public title
evaluation of the treatment method of nephrolithiasis with with shock wave in infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
all patient with erectile dysfunction who dont be treated with PDEi drugs
Exclusion criteria:
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
31
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
during this study, for 6 weeks and every week a session of shockwave therapy with 0.25mJ/mm2 energy was performed for patients and follow up three months later
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی تبریز
Street address
no.13.dr hesabi square.shahgoli.tabriz.iran
City
tabriz
Province
East Azarbaijan
Postal code
۵۱۶۶۸۱۱۷۰۷
Approval date
2023-05-08, 1402/02/18
Ethics committee reference number
IR.TBZMED.REC.1402.102
Health conditions studied
1
Description of health condition studied
erectile dysfunction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
erection
Timepoint
at the beginning of study and 3 months after shockwave therapy
Method of measurement
IIEF questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients with erectile dysfunction that can't have appropriate erection after receiving maximum dose of PDE5i drugs for 4 times
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
urology clinic of Emma reza hospital
Full name of responsible person
faraji
Street address
no13.dr hesabi square.shahgoli.tabriz.iran
City
tabriz
Province
East Azarbaijan
Postal code
5166811707
Phone
+98 914 427 2432
Email
aidajamlou@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
dr tayebi
Street address
no13.dr hesabi square.shahgoli.tabriz.iran
City
tabriz
Province
East Azarbaijan
Postal code
۵۱۶۶۸۱۱۷۰۷
Phone
+98 914 427 2432
Email
aidajamlou@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
aida jamlou
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
no13.dr hesabi square.shahgoli.tabriz. iran
City
tabriz
Province
East Azarbaijan
Postal code
۵۱۶۶۸۱۱۷۰۷
Phone
+98 41 3380 0137
Email
aidajamlou@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
dr mohsen Mohammad Rahimi
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
no13.dr hesabi square.shahgli.tabriz.iran
City
tabriz
Province
East Azarbaijan
Postal code
۵۱۶۶۸۱۱۷۰۷
Phone
۰۰۹۸۹۴۱۳۳۸۰۰۱۳۷
Email
aidajamlou@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
dr mohsen Mohammad Rahimi
Position
assistant professer
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
no13.dr hesabi square.shahgoli.tabriz.iran
City
tabriz
Province
East Azarbaijan
Postal code
5166811707
Phone
+98 41 3380 0137
Email
aidajamlou@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD