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IRCT20201006048949N1 IRCT 2021-08-10 Mashhad University of Medical Sciences The effect of radiofrequency on improvement of vaginalaxity and loss of sexuality in women Investigation of the effect of radiofrequency on improvement of vaginalaxity and loss of sexuality in women referring to Mashhad educational hospital clinics 2021-07-28 anticipated 30 Complete https://irct.ir/trial/56093 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Vaginalaxity. Intervention group: In this group, treatment was ambulatory and was done in a clinic. Patients are treated with a radiofrequency device in three sessions and each session lasts 30 minutes within 1 to 3 months. This thermotherapy device uses radiofrequency technology to treat vaginal laxity and rejuvenate the external genitalia in women. This device can work with four different frequencies (420,500,720,1000), which allows changing the depth of penetration of the waves according to the type of patient's problem and the type of treatment needed.. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable. When: Data can be accessible 6 months after results are published. To whom: Data can be accessible through an email to the corresponding author. Conditions: Data will be available for researchers in universities and other scientific institutes. Where to obtain: After sending a request email to the corresponding author, data will be sent in 1 month. How to obtain: Carrying out analysis on data is permitted. Comments:
public Azimeh Golzar
NO. 31, Haft Tir 3 St., Vakilabad Blvd.,
Mashhad Iran (Islamic Republic of) 9178864689 +98 51 3727 9757 golzarta961@mums.ac.ir Mashhad University of Medical Sciences scientific Nafiseh Saghafi
Ahmadabad Blvd., Ghaem Hospital
Mashhad Iran (Islamic Republic of) 99199-91766 +98 51 3841 7493 SaghafiN@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age between 25-50 years Having complaints of vaginal laxity Not having breastfed within the the three months before the study Sexual activity (vaginal sex at least once a month) Normal Pap test result Negative pregnancy test before entering the study 25 years 50 years Female Pelvic organ prolapse has exceeded the hymenal ring (grade 3 and 4 prolapse) Active sexually transmitted disease (Condylomata acuminata / herpes) Chronic vulvar pain or vulvar dystrophy Using known medications that affect sexual function (antihypertensive and psychotropic drugs / chemotherapeutic agents) Daily use of anti-inflammatory drugs which can affect collagen in healing (ibuprofen / aspirin / steroids) Chronic skin disorder including vulvar involvement Medical problem that interferes with wound healing. Thin rectovaginal septum Under treatment for Hypoactive Sexual Desire Disorder (HSDD) or orgasmic disorder Irritable bowel syndrome (IBS) N81 Female genital prolapse Treatment - Devices Intervention group: In this group, treatment was ambulatory and was done in a clinic. Patients are treated with a radiofrequency device in three sessions and each session lasts 30 minutes within 1 to 3 months. This thermotherapy device uses radiofrequency technology to treat vaginal laxity and rejuvenate the external genitalia in women. This device can work with four different frequencies (420,500,720,1000), which allows changing the depth of penetration of the waves according to the type of patient's problem and the type of treatment needed. Sexual function. Timepoint: Before the intervention, at months 1, 2, 3 during the study before each treatment session, and 3and 6 months after the intervention. Method of measurement: Female Sexual Function Index. Vaginal laxity. Timepoint: Before the intervention, at months 1, 2, 3 during the study before each treatment session, and 3and 6 months after the intervention. Method of measurement: Vaginal Laxity Questionnaire. Mashhad University of Medical Sciences Approved 2020-09-26 Ethics Committee of Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)