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IRCT20190624043991N23 IRCT 2023-12-07 Tehran University of Medical Sciences The effectiveness of botulinum A injection in the treatment of premature ejaculation patients Investigating the effectiveness of botulinum A subdermal injection in the treatment of patients with premature ejaculation resistant to treatment: a clinical trial 2024-03-16 anticipated 30 Complete https://irct.ir/trial/74122 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Premature ejaculation in patients. Intervention 1: 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. Intervention 2: Control group: Injection of 1 cc of normal saline under the skin of the glans region: 15 patients. Yes - There is a plan to make this available What will be shared: Demographic information anonymously When: One year after publication To whom: Researchers working in academia, physicians, surgeons and hospitals. Conditions: Any analysis can be done with the consent of the main researcher Where to obtain: Sina Hospital, Urology Research Center, Head of Urology Research Center: Dr. Seyed Mohammad Kazem Aghamir 00982166348560 mkaghamir@tums.ac.ir How to obtain: After reviewing the information by the administrator and epidemiologist, the patient information will be available for the applicant by providing a patient's privacy. Comments:
public Dr Akram Mirzaei
Urology Research Center- Sina Hospital - Imam Khomeini St
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8560 mirzaee.scholar@gmail.com Tehran University of Medical Sciences scientific Dr Mohammad Kazem Aghamir
Urology Research Center- Sina Hospital - Imam Khomeini St
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8560 mkaghamir@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Informed consent from patients Having treatment-resistant premature ejaculation no limit no limit Male 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 F52.4 Premature ejaculation Treatment - Drugs Placebo 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 Control group: Injection of 1 cc of normal saline under the skin of the glans region: 15 patients Intravaginal ejaculation latency. Timepoint: Before and 4 weeks after injection. Method of measurement: Premature ejaculation diagnosis questionnaire. Tehran University of Medical Sciences Approved 2023-10-22 Research Ethics Committee, Sina Hospital Room 206, Ethics Committee Office، Second Floor, Administrative Building،Sina Hospital، Imam Khomeini Street,Tehran,Iran Tehran Tehran Iran (Islamic Republic of)