Investigating the effectiveness of botulinum A subdermal injection in the treatment of patients with premature ejaculation resistant to treatment: a clinical trial
Effectiveness of intradermal botulinum a injection in the treatment of treatment-resistant premature ejaculation patients
Design
Clinical trial with two patient groups, parallel, treatment, balanced block randomization, single-blind (researcher). 30 patients referred to Sinai Hospital.
Settings and conduct
This clinical trial will be conducted in Tehran Sina Hospital, Urology Research Center, single-blind (researcher), balanced block randomization and Weber on 30 patients. Patients are divided into two groups: First group: injection of 100 units of botulinum toxin-A with a concentration of 100 units/ml under the skin of the glans region: 15 patients.
The second group: injection of 1 cc of normal saline under the skin of the glans region: 15 patients
Participants/Inclusion and exclusion criteria
Inclusion criteria: informed consent of the patients / having premature ejaculation resistant to treatment.
Exclusion criteria: other sexual diseases such as impotence and decreased sexual desire / any skin disease and infection of the genital area / history of allergy to injectable drugs / injecting drug addicts or any drug addiction/patients who are withdrawing from drugs
Intervention groups
The first group: injection of 100 units of botulinum toxin-A with a concentration of 100 units/ml under the skin of the glans region: 15 patients
The second group: injection of 1 cc of normal saline under the skin of the glans region: 15 patients
Main outcome variables
Intravaginal ejaculation delay time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190624043991N23
Registration date:2023-12-07, 1402/09/16
Registration timing:prospective
Last update:2023-12-07, 1402/09/16
Update count:0
Registration date
2023-12-07, 1402/09/16
Registrant information
Name
Seyed Mohammad Kazem Aghamir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8560
Email address
mkaghamir@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-16, 1402/12/26
Expected recruitment end date
2025-03-16, 1403/12/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of botulinum A subdermal injection in the treatment of patients with premature ejaculation resistant to treatment: a clinical trial
Public title
The effectiveness of botulinum A injection in the treatment of premature ejaculation patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent from patients
Having treatment-resistant premature ejaculation
Exclusion criteria:
Other sexual diseases such as erectile dysfunction and decreased libido
Any skin disease and genital infection
History of allergy to injectable drugs
Injection drug addicts or any type of drug addiction
Patients who are withdrawing from drugs
Age
No age limit
Gender
Male
Phase
3
Groups that have been masked
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the Permuted balanced block randomization method will be used by creating blocks of four between the two treatment and control groups in a random way. According to the randomization method, the two groups will have a difference of at most two people in the number of allocated people. After the statistics and epidemiology specialist prepares the randomization sequence, the patients will be placed in blocks a and b. Based on the first selection of the patient as a (first group), the next patient will be placed in group b (second group).
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be single-blind. The researcher will not know about the treatment process. The researcher will not know about injecting 100 units of botulinum toxin-A with a concentration of 100 units/ml or injecting one cc of normal saline under the skin of the glans.
Intervention group: Injection of 100 units of botulinum toxin-A with a concentration of 100 units/ml under the skin of the glans region: 15 patients
Category
Treatment - Drugs
2
Description
Control group: Injection of 1 cc of normal saline under the skin of the glans region: 15 patients
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Mohammad Kazem Aghamir
Street address
Urology Research Center, Sina Hospital, Imam Khomeini St., Tehran, Iran .
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
+98 21 6634 8553
Email
mkaghamir@tums.ac.ir
Web page address
http://urc.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Sixth Floor, Central University, Quds Ave., Keshavarz Boulevard, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Fax
+98 21 8163 3686
Email
vcr@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
https://URC@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Kazem Aghamir
Position
Head of Urology Research Center
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mkaghamir@tums.ac.ir
Web page address
http://urc.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
https://URC@tums.ac.ir
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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Demographic information anonymously
When the data will become available and for how long
One year after publication
To whom data/document is available
Researchers working in academia, physicians, surgeons and hospitals.
Under which criteria data/document could be used
Any analysis can be done with the consent of the main researcher
From where data/document is obtainable
Sina Hospital, Urology Research Center, Head of Urology Research Center: Dr. Seyed Mohammad Kazem Aghamir 00982166348560 mkaghamir@tums.ac.ir
What processes are involved for a request to access data/document
After reviewing the information by the administrator and epidemiologist, the patient information will be available for the applicant by providing a patient's privacy.