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IRCT20190708044143N1 IRCT 2019-09-01 Tehran University of Medical Sciences Comparison the effect of radiofrequency and laser treatment on mixed urinary incontinence and vulvovaginal atrophy Comparison the effect of radiofrequency and laser treatment on symptoms of Iranian menopausal women with mixed urinary incontinence and vulvovaginal atrophy 2018-12-22 anticipated 240 Complete https://irct.ir/trial/40663 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: According to random numbers table. N/A Mixed Urinary Incontinence. Intervention 1: Intervention 1: Laser treatment will consist of a series of 2 treatments, 4 weeks apart, taking about 1-2 min per session, as an in-office procedure using Monalisa Touch device aimed at treatment of VVA, UI, and sexual problems. Intervention 2: Intervention group 2: In RF therapy group, all patients have 3 sessions of treatment, with 4-6 weeks frequency. Each session will be held in groups for 30 minutes with a working temperature range of 40–45°C. Intervention 3: Control group: no treatment. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Laila Ghorbani
Valiasr Hospital, After Mirdamad, Shariati Ave.
Tehran Iran (Islamic Republic of) 1996714184 +98 21 8123 5043 l.ghorbani@icloud.com Tehran University of Medical Sciences scientific Laila Ghorbani
Valiasr Hospital, After Mirdamad, Shariati Ave.
Tehran Iran (Islamic Republic of) 1996714184 +98 21 8123 5043 l.ghorbani@icloud.com Tehran University of Medical Sciences Iran (Islamic Republic of) history of UI symptoms having sexual intercourse having sexual problems due to vulvovaginal atrophy (VVA) at least one year past from the termination of menstruation presence of VVA symptoms sexual dysfunction no limit no limit Female urinary infection hematuria pelvic organ prolapse ICS>2 pregnancy childbirth in less than a year abnormal vaginal bleeding damaged vaginal tissue history of damage to spinal nerves radical hysterectomy with noropathy epilepsy autoimmune diseases leakage of urine more than 50 g per hour N39.4 Other specified urinary incontinence Treatment - Other Treatment - Other Placebo Intervention 1: Laser treatment will consist of a series of 2 treatments, 4 weeks apart, taking about 1-2 min per session, as an in-office procedure using Monalisa Touch device aimed at treatment of VVA, UI, and sexual problems. Intervention group 2: In RF therapy group, all patients have 3 sessions of treatment, with 4-6 weeks frequency. Each session will be held in groups for 30 minutes with a working temperature range of 40–45°C. Control group: no treatment Urinary incontinence includes the frequency of urinary leakage, urine leakage, the effect of urine leakage on quality of life and urinary leakage time. Timepoint: pre and post of intervention. Method of measurement: ICIQ-SF questionnaire. Vaginal atrophy including burning, itching, dryness, dispersion and dysuria. Timepoint: pre and post of intervention. Method of measurement: Visual analog score. Vic-Chancellor in Research of Tehran University of Medical Sciences Approved 2019-05-01 Ethics Committee of Tehran University of Medical Sciences No.78, Moosivand avenue, Shariati street Tehran Tehran Iran (Islamic Republic of)