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Набор по приглашению NCT07319247

Laser Therapy and Pelvic Floor Muscle Training for Stress Urinary Incontinence

Без фазы С лечением Urinary Incontinence (UI) Laser Therapy Stress Urinary Incontinence (SUI) Pelvic Floor Muscle Exercise

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: PFME and Laser Therapy, Plasebo Laser, PFME.
Кому может быть актуально
Состояния в реестре: Urinary Incontinence (UI), Laser Therapy, Stress Urinary Incontinence (SUI), Pelvic Floor Muscle Exercise. Базовые параметры: 18 лет — 65 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

The Effect of High-frequency Laser Therapy and Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence: A Plasebo Randomized Controlled Trial

Обзор

The aim of this study was to investigate the effects of Pelvic Floor Muscle Training (PFMT) in addition to high-intensity laser therapy (HILT) on pelvic floor dysfunction, sexual dysfunction, and quality of life in women with stress urinary incontinence. Women with SUI will be randomly assigned to PFMT (Group I), Laser + PFMT (Group II), and placebo laser (Group III). PFMT will be administered twice weekly for 12 weeks under the supervision of a physiotherapist. PFMT will be administered with biofeedback. HILT will be applied to six points in the perineal region . The intensity will be 6W, the energy density will be 120J/cm2, and three sessions will be administered weekly for a total of six sessions. Women included in the study will be evaluated twice, at the beginning and at the end of the treatment, with the Incontinence Quality of Life Scale (I-QOL), Incontinence Severity Index (ISI), Female Sexual Function Scale-(FSFI), and Global Pelvic Floor Impact Questionnaire (GPTRA).

Вмешательства

  • Поведенческое PFME and Laser Therapy
    PFMT, patients are taught pelvic floor exercises, which involve slow and fast muscle contractions that train both Type 1 and Type 2 muscle fibers, using vaginal palpation. During fast contractions, patients are asked to quickly contract and relax their pelvic floor muscles. The image of "turning the faucet off and on" is used to help patients better understand this exercise. During slow contractions, patients are asked to slowly tighten their pelvic floor muscles, hold them for 10 seconds, and t
  • Поведенческое Plasebo Laser
    This group will only receive placebo laser treatment. The ND: YAG laser system was configured identically, except for the addition of a metal shielding plate to the hand tool to block energy, which had no therapeutic effect, during treatment. The laser device will be aimed at 6 points in the perineal area . Assessments will be conducted twice, baseline and post treatment (at 12 weeks).
  • Поведенческое PFME
    In this training, patients are taught pelvic floor exercises, which involve slow and fast muscle contractions that train both Type 1 and Type 2 muscle fibers, using vaginal palpation. During fast contractions, patients are asked to quickly contract and relax their pelvic floor muscles. The image of "turning the faucet off and on" is used to help patients better understand this exercise. During slow contractions, patients are asked to slowly tighten their pelvic floor muscles, hold them for 10 se

Первичные конечные точки

  • Urinary incontinence severity [Срок оценки: baseline, post treatment (at 12 week)]
  • The impact of urinary incontinence on quality of life [Срок оценки: baseline, post treatment (at 12 week)]
  • pelvic floor dysfuntion severity [Срок оценки: baseline, post treatment (at 12 week)]
Вторичные конечные точки (2)
  • Sexually Dysfunction [Срок оценки: baseline, post treatment (at 12 week)]
  • pelvic floor muscle function [Срок оценки: baseline, post treatment (at 12 week)]

Критерии участия

Критерии включения

  • Women aged 18-65,
  • Women who are volunteers and committed to work,
  • Women diagnosed with stress urinary incontinence,

Критерии исключения

  • Pregnancy,
  • Previous surgery in the treatment area within 12 months,
  • Active genital infection,
  • Presence of malignancy,
  • Systemic steroid use in the last 3 months,
  • Use of vaginal lubricant within the last 7 days,
  • Recurrent urinary tract or genital herpes,
  • POP-Q score 3 or higher

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Physical Therapy Hospital — Meram

Идентификаторы

NCT: NCT07319247 · hlaser

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗