Investigating the effect of adjutant therapy of cranial electrical stimulation (CES) on premature ejaculation disorder.
Design
A randomized, single-blind, placebo-controlled design of 30 patients trial. With simple randomization method.
Settings and conduct
The study was performed on patients referred to the Sexual Disorders Clinic of Taleghani Hospital.
Patients with premature ejaculation disorder are included in the study.
The standard treatment is prescribed to all patients.
The intervention is perform in addition to standard drug treatment.
Patients do not know whether they are in the placebo group or the test group.
Participants/Inclusion and exclusion criteria
inclusion criteria: Married men 18 to 65 years old with premature ejaculation disorder.
exclusion criteria: Diabetes, hypertension and other diseases affecting premature ejaculation disorder.
Intervention groups
Cranial electrical stimulation with standard drug treatment.
Inactive device with standard drug treatment (Placebo).
Main outcome variables
Rates of treatment; Duration of treatment; Need to take medicine; Side effects of treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210621051657N1
Registration date:2022-12-11, 1401/09/20
Registration timing:prospective
Last update:2022-12-11, 1401/09/20
Update count:0
Registration date
2022-12-11, 1401/09/20
Registrant information
Name
Hadi Delpasand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5506 1535
Email address
delpasand@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-06-21, 1402/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect adjuvant therapy of cranial electrical stimulation (CES) in premature ejaculation disorder patients.
Public title
Investigating the effect of adjuvant therapy of cranial electrical stimulation (CES) on premature ejaculation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male sex.
Married.
Age 18 to 65 years.
With premature ejaculation disorder.
Exclusion criteria:
Men with diabetes, hypertension and other diseases affecting premature ejaculation.
Age
From 18 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization method is used. Random allocation software is used to create a random sequence. The sequentially numbered, opaque sealed envelopes (SNOSE) method is used to allocation concealment.
Blinding (investigator's opinion)
Single blinded
Blinding description
To reduce bias , the single-blind method is used. In this method, the participant does not know which of the two groups of placebo or test belongs.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Medicine - Shahid Beheshti University of Medical Sciences (Research Ethics Committee)
Street address
Koodakyar Dead End, Shahid Shahriari square, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717434
Approval date
2021-06-15, 1400/03/25
Ethics committee reference number
IR.SBMU.MSP.REC.1400.147
Health conditions studied
1
Description of health condition studied
Premature ejaculation
ICD-10 code
F52.4
ICD-10 code description
Premature ejaculation
Primary outcomes
1
Description
Premature ejaculation by Premature Ejaculation Diagnostic Tool (Questionnaire)
Intervention group: Cranial electrical stimulation with a frequency of 250 Hz and intensity 3, for 3 weeks, 2 sessions per day and the duration of each session is 20 minutes. + Standard drug treatment(Tablet Sertraline 50 mg, 4 hours before sexual intercourse).
Category
Treatment - Devices
2
Description
Control group: Use the disabled device as the intervention group + Standard drug treatment(Tablet Sertraline 50 mg, 4 hours before sexual intercourse).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
(Ayatollah) Taleghani Educational Hospital-Tehran
Full name of responsible person
Mis Zarei
Street address
Aarabi St, Velenjak
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Fax
+98 21 2243 2570
Email
taleghanihospital@sbmu.ac.ir
Web page address
https://taleghani.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Arabi Ave, Velenjak
City
Tehram
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9770
Email
Intl_office@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azadeh mazaheri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Taleqani hospital, Arabi Ave, Velenjak
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Email
mazaheri.azadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azadeh mazaheri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Taleqani hospital, Arabi Ave, Velenjak
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Email
mazaheri.azadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hadi Delpasand
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Taleqani hospital, Arabi Ave, Velenjak
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1111
Fax
Email
delpasand@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available