Evaluation of the effect of carboxytherapy in the treatment of stress urinary incontinence and sexual dysfunction

Determining and comparing the effect of carboxytherapy in the treatment of stress urinary incontinence and sexual dysfunction

A randomized, Single-blinding clinical trial, with the parallel groups, Phase 3 on 60 patients

In this single-blind randomized clinical trial, 60 women eligible for inclusion in the study that refer to the clinic of Al-Zahra and Kashani hospitals in Isfahan will be included in the study and randomly divided into 2 groups. The first group will receive carbon dioxide(CO2) injection in the vaginal tissue, and the second group as the control group will not receive this treatment. Then, the score of stress urinary incontinence and the score of their sexual dysfunction in both groups will be compared.

Inclusion criteria consist of women with stress urinary incontinence or sexual dysfunction, within the age range of 35-65 years, and at least one vaginal delivery or cesarean section. Exclusion criteria include active vaginal bleeding, vaginal infection, abnormal Pap smear, pregnancy, urinary tract infection, recent pelvic surgery, grade 2 or more pelvic organ prolapse, and treatment with antiplatelet or anticoagulant drugs.

Intervention group: In this group, 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, 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.

Stress urinary incontinence score; Sexual dysfunction score

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.

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.

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