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IRCT20091012002576N20 IRCT 2021-07-02 Tehran University of Medical Sciences The effect of Botox on chronic pelvic pain and sexual satisfaction in women with endometriosis Comparison of chronic pelvic pain and sexual satisfaction in women with endometriosis in two groups with and without botulinum toxin injection 2021-09-23 anticipated 32 Complete https://irct.ir/trial/57209 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation rule: First, 16 letters A and 16 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patient. In addition, interventions A (botulinum toxin) or B (normal saline) are determined by a lot, Blinding description: This study is performed double-blind, the participants and the analyzer do not know the type of treatment. Patients in the control group do not know their group therapy, with using the normal saline injection in Botox-like syringes. Also, the data analyzer does not know the codes defined for the treatment groups in the SPSS file. 3 Endometriosis. Intervention 1: Intervention group: After a vaginal digital examination to identify pelvic muscles with spasms, and 20 to 30 minutes before the start of the intervention, up to 10 mg of oral diazepam is administered and lidocaine cream 4% is applied to the determined location in the vaginal mucosa. Then, a vial of 100 units of anabotulinum toxin A (Botox) is placed in 4 ccs of saline (final concentration 25 units/ml). The injection is performed by a gynecologist with experience in endometriosis using a sterile technique. When Botox is injected into one muscle, the removed needle is then inserted into the next muscle. In fact, the total dose of 100 units is divided between three to four identified areas of muscles with spasms. Intervention 2: Control group: After a vaginal digital examination to identify pelvic muscles with spasms, and 20 to 30 minutes before the start of the intervention, up to 10 mg of oral diazepam is administered and lidocaine cream 4% is applied to the determined location in the vaginal mucosa. Then, two to five ccs of normal saline are prepared. The injection is performed by a gynecologist with experience in endometriosis using a sterile technique. When normal saline is injected into one muscle, the removed needle is then inserted into the next muscle. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified participants When: After manuscript published To whom: No limitations Conditions: The data is only available to the project manager, Dr. Davari-Tanha, and any analysis must be done with her opinion. Where to obtain: Dr. Davari-Tanha fdavaritanha@sina.tums.ac.ir How to obtain: Any request for data must be sent to Dr. Davari-Tanha by email and accompanied by a written proposal confirmed by a local ethics committee. Comments:
public Fatemeh Davari Tanha
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
Tehran Iran (Islamic Republic of) 1597856511 +98 21 8831 3955 fdavaritanha@sina.tums.ac.ir Tehran University of Medical Sciences scientific Fatemeh Davari Tanha
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
Tehran Iran (Islamic Republic of) 1597856511 +98 21 8831 3955 fdavaritanha@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age 18-50 years Chronic pelvic pain for at least 3 months Do not start new analgesic strategies since one month before the intervention 18 years 50 years Female The primary cause of chronic pelvic pain is the following: infection, gastrointestinal or psychological disorder, fibromyalgia, chronic fatigue syndrome Severe untreated cervical dysplasia History of hysterectomy and bilateral salpingo-oophorectomy Allergy to botulinum toxin Pregnancy or breastfeeding History of urinary and fecal incontinence Known pelvic prolapse Neuromuscular disorders such as myasthenia gravis or Lambert Aton syndrome N80.9 Endometriosis, unspecified Treatment - Drugs Placebo Intervention group: After a vaginal digital examination to identify pelvic muscles with spasms, and 20 to 30 minutes before the start of the intervention, up to 10 mg of oral diazepam is administered and lidocaine cream 4% is applied to the determined location in the vaginal mucosa. Then, a vial of 100 units of anabotulinum toxin A (Botox) is placed in 4 ccs of saline (final concentration 25 units/ml). The injection is performed by a gynecologist with experience in endometriosis using a sterile technique. When Botox is injected into one muscle, the removed needle is then inserted into the next muscle. In fact, the total dose of 100 units is divided between three to four identified areas of muscles with spasms. Control group: After a vaginal digital examination to identify pelvic muscles with spasms, and 20 to 30 minutes before the start of the intervention, up to 10 mg of oral diazepam is administered and lidocaine cream 4% is applied to the determined location in the vaginal mucosa. Then, two to five ccs of normal saline are prepared. The injection is performed by a gynecologist with experience in endometriosis using a sterile technique. When normal saline is injected into one muscle, the removed needle is then inserted into the next muscle. Chronic pelvic pain. Timepoint: Twice, before the intervention and one month after the intervention. Method of measurement: Visual Analog Scale (VAS Ruler). Sexual satisfaction rate. Timepoint: Once, at the end of the study. Method of measurement: Female Sexual Function Index Scoring. Dysmenorrhea. Timepoint: Twice, before the intervention and one month after the intervention. Method of measurement: Visual Analog Scale (VAS Ruler). Dyspareunia. Timepoint: Twice, before the intervention and one month after the intervention. Method of measurement: Visual Analog Scale (VAS Ruler). Tehran University of Medical Sciences Approved 2021-06-14 Ethics committee of Tehran university of medical sciences Tehran University of Medical Sciences,School of Medicine, Tehran Province, Tehran, Pour Sina St" to "Tehran University of Medical Sciences,School of Medicine, Tehran Province, Tehran, Pour Sina St Tehran Tehran Iran (Islamic Republic of)