Preliminary Outcome Of Tecar On Stress Urinary Incontinence, Pelvic Floor Strength And Sexual Satisfaction In Women With Vaginal Relaxation Syndrome

Официальное название

Preliminary Outcome Of Tecar Therapy Effect On Stress Urinary Incontinence, Pelvic Floor Strength And Sexual Satisfaction In Women Complaining Of Vaginal Relaxation Syndrome: A Randomized Controlled Trial

Обзор

Forty women aged 50-60 years with a body mass index (BMI) of 25 kg/m2 to 30 kg/m2, who complain of stress urinary incontinence and vaginal laxity, will be separated randomly into two equivalent groups. In group (A) 20 women will receive TECAR therapy for 15 min and pelvic floor exercise for 20 min, while in group (B), 20 females will receive sham treatment for 15 min and pelvic floor exercise for 20 min twice per week for 8 weeks. Both groups wil be assessed using a perineometer as an assessment tool for pelvic floor muscle strength muscles and the Visual Analog Scale, ICIQ-UI short form questionnaire about the frequency of urinary incontinence symptoms, Millheiser Sexual Satisfaction Scale, and the Sexual Quality of Life Questionnaire-Female (SQOL-F) to assess sexual satisfaction by each patient before, after 4 weeks, and after 8 weeks of treatment

Вмешательства

• Устройство TECAR device: MCRR. The sign producer is an INDIBA® 448 kHz RF device that has a vaginal/ or rectum electrode (made in Barcelona, Spain)
  TECAR (Transfer Electrical, Capacitive, and Resistive) is originally used in Italy. TECAR therapy is a radiofrequency (RF) therapy, which produces high-frequency waves. RF can be capacitive or resistive The capacitive mode (CET) generates energy in electrolyte-rich soft tissues such as muscles and vascular or lymphatic tissues . The resistive mode (RET) directs energy to deeper tissues that contain more fat and fibers (such as bones, ligaments, and tendons;
• Процедура pelvic floor exercises
  pelvic floor exercise will be performed with the perineometer twice a week for eight weeks (16 sessions), with five sets of 20 repetitions each
• Устройство Sham device
  sham treatment by Tecar device for 15 min without producing any waves.

Первичные конечные точки

• pelvic floor muscle strength assessed using a Peritron (9300) device with a vaginal sensor [Срок оценки: after 4 and 8 weeks]
• urinary incontinence symptoms using Visual Analog Scale and ICIQ-UI short form questionnaire [Срок оценки: after 4 and 8 weeks]
• sexual satisfaction using Millheiser Sexual Satisfaction Scale, and the Sexual Quality of Life Questionnaire-Female (SQOL-F) [Срок оценки: after 4 and 8 weeks]
• Vaginal PH using PH color strips [Срок оценки: at baseline, after 4 weeks, and after 8 weeks of treatment]

Критерии участия

Критерии включения

• participants are multipara at least two times with sexual activity for at least 1/month with normal cell cytology (PAP smear), integrity of the vaginal canal mucosa, and negative urine culture (without injuries or bleeding).

Критерии исключения

• pregnancy, use of photosensitive medicines, vaginal bleeding injury or infection in the treated area, and use of an IUD.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06788574 · (P.T.WH/3/2021/9).

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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