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IRCT20200825048515N27 IRCT 2021-04-03 Esfahan University of Medical Sciences The effect of carboxytherapy in the treatment of stress urinary incontinence and sexual dysfunction Evaluation of the effect of carboxytherapy in the treatment of stress urinary incontinence and sexual dysfunction 2021-04-20 anticipated 60 Complete https://irct.ir/trial/55099 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 60 eligible patients will be randomly selected. Then random numbers are created by computer software "Random Allocation". We randomly divide these numbers into two parts. Each number is written on paper and placed in an envelope. Then each patient is asked to choose an envelope from among the envelopes. According to the selected envelope, the patient will be assigned to one of the two groups, Blinding description: Due to the fact that in this study, carbon dioxide (CO2) is injected in three areas of the vagina in one group and a needle is inserted in three areas of the vagina in the other group, but no injection is performed, so the researcher will be aware of the type of intervention. But due to the similarity in performance, the patient does not know the type of intervention. Also, the statistical analyst will not be aware of the type of intervention. 3 Condition 1: Sexual dysfunction. Condition 2: Stress urinary incontinence. Intervention 1: Intervention group: In this group, a 30 gauge needle with a length of 12 mm and an injection angle of 15 degrees will inject 30 cc of carbon dioxide (CO2) in three areas of the vagina. Each person will undergo carboxytherapy twice a week for 2 months. Intervention 2: Control group: In this group, a 30 gauge needle with a length of 12 mm and an injection angle of 15 degrees will be inserted in three areas of the vagina, but carbon dioxide (CO2) will not be injected. It should be noted that the insertion of the needle into the vaginal tissue even without the injection of carbon dioxide (CO2) stimulates collagen production and is not harmful to the patient. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Zahra Allameh
Department of Obstetrics and Gynecology, Al-Zahra Hospital, Sofeh Blvd., Tohid Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 z-allameh@med.mui.ac.ir Esfahan University of Medical Sciences scientific Zahra Allameh
Department of Obstetrics and Gynecology, Al-Zahra Hospital, Sofeh Blvd., Tohid Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 z-allameh@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) women with stress urinary incontinence or sexual dysfunction within the age range of 35-65 years Have at least one vaginal delivery or cesarean section 35 years 65 years Female Having active vaginal bleeding Having vaginal infection Having abnormal Pap smear Pregnancy Having urinary tract infection Recent pelvic surgery Having grade 2 or more pelvic organ prolapse Treatment with antiplatelet or anticoagulant drugs F52 N39.3 Sexual dysfunction not due to a substance or known physiological condition Stress incontinence Treatment - Other Placebo Intervention group: In this group, a 30 gauge needle with a length of 12 mm and an injection angle of 15 degrees will inject 30 cc of carbon dioxide (CO2) in three areas of the vagina. Each person will undergo carboxytherapy twice a week for 2 months. Control group: In this group, a 30 gauge needle with a length of 12 mm and an injection angle of 15 degrees will be inserted in three areas of the vagina, but carbon dioxide (CO2) will not be injected. It should be noted that the insertion of the needle into the vaginal tissue even without the injection of carbon dioxide (CO2) stimulates collagen production and is not harmful to the patient. Urinary stress incontinence score. Timepoint: Before, one and three months after the intervention. Method of measurement: Questionnaire-Urinary Incontinence Short Form(ICIQ-UI SF). Sexual dysfunction score. Timepoint: Before, one and three months after the intervention. Method of measurement: Short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Isfahan University of Medical Sciences Approved 2020-12-04 Ethics committee of Isfahan University of Medical Sciences Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)