- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07693920
The Effects of Expiratory Muscle Strength Training in Women With Stress Urinary Incontinence
Investigation of the Effects of Expiratory Muscle Strength Training in Addition to Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence
Обзор исследования
Статус
Условия
Подробное описание
According to the International Continence Society definition, stress urinary incontinence (SUI) is the involuntary leakage of urine during physical exertion, including exertion or sports activities, or during sneezing or coughing. Pelvic floor muscle training, a conservative approach, is recommended as the first-line treatment for SUI. As a classic approach, there is A-level evidence that isolated pelvic floor muscle training in women improves SUI and SUI-related quality of life. While inspiratory muscle training has been reported in the literature as effective in SUI, research on expiratory muscle strength training is needed. Therefore, studying expiratory muscle strength in SUI is important. Inclusion criteria for the study were: having SUI, being female, and being aged 18-65 years. Exclusion criteria were: The following criteria were contraindicated: presence of neurological disease, neurogenic bladder findings, pregnancy, presence of malignancy, history of abdominopelvic surgery or radiotherapy within the last 6 months, diagnosis of urinary tract infection, presence of uncontrolled hypertension, presence of advanced pelvic organ prolapse (stage 3 and above), and pelvic floor muscle squeezing strength <2 on the Modified Oxford Scale during digital examination. Women will be randomly assigned to one of two intervention groups: Group 1: Pelvic Floor Muscle Training (PFMT) and Group 2: PFMT plus Expiratory Muscle Strength Training. The groups will be blinded. The intervention program will last 8 weeks in both groups. Women will be evaluated at the beginning of the study (before interventions) and at the end of the 8th week of intervention. Both groups will be asked to perform the exercises included in the PFMT program as a home program after being taught in the clinic, and individuals will be called for follow-up check-ups every two weeks with an exercise schedule. At each follow-up session, one set of exercises will be performed with the physiotherapist to re-check the accuracy of the exercises, and the number of exercises will be increased before the women are invited to the next appointment.
Respiratory muscle strength will be measured using a portable, electronic mouth pressure monitor. Pelvic floor muscle strength will be graded using the Modified Oxford Scale (MOS). Objective incontinence severity will be assessed with a 1-hour pad test. The subjective severity of incontinence and its impact on daily life will be assessed with the International Incontinence Consultation Questionnaire-Short Form (ICIQ-UI SF). At the end of treatment, women's perceptions of improvement in their urinary incontinence levels will be assessed using the "Patient Global Improvement Perception Scale". A device will be used in training to increase expiratory muscle strength. Expiratory muscle strength training will be done at home 7 days a week, once a day, with a cycle of 25 breaths, and a 1-minute rest after every 5 breaths. Women will be taught rapid-maximal isolated contractions and high-repetition submaximal isolated contractions via vaginal palpation as part of the PTKE program.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Women aged 18-65 with SUI
Exclusion Criteria:
- Presence of neurological disease
- Neurogenic bladder findings,
- Pregnancy,
- Presence of malignancy,
- History of abdominopelvic surgery or radiotherapy within the last 6 months,
- Diagnosis of urinary tract infection,
- Presence of uncontrolled hypertension,
- Presence of advanced pelvic organ prolapse (stage 3 and above),
- Pelvic floor muscle tightening strength <2 according to the Modified Oxford Scale on digital examination.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Pelvic Floor Muscle Training
Women will receive a pelvic floor muscle training program.
|
As part of the PTKE program, women will be taught rapid-maximal isolated contractions and multiple-repeated submaximal isolated contractions via vaginal palpation.
|
|
Экспериментальный: Pelvic Floor Muscle Training plus Expiratory Muscle Strength Training
Participants will receive pelvic floor muscle training combined with Expiratory Muscle Strength Training.
|
As part of the PTKE program, women will be taught rapid-maximal isolated contractions and multiple-repeated submaximal isolated contractions via vaginal palpation.
Expiratory muscle strength training will be done at home 7 days a week, once a day with 25 breaths, and a 1-minute rest cycle after every 5 breaths.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
Временное ограничение: Baseline and after 8 weeks of intervention.
|
The subjective severity of incontinence and its impact on daily life will be assessed using the International Incontinence Consultation Questionnaire-Short Form (ICIQ-UI SF).
|
Baseline and after 8 weeks of intervention.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Respiratory Muscle Strength Assessment
Временное ограничение: Baseline and 8 weeks
|
Respiratory muscle strength will be measured using a portable measuring device.
|
Baseline and 8 weeks
|
|
Pelvic Floor Muscle Strength
Временное ограничение: Baseline and 8 weeks
|
Pelvic floor muscle strength will be assessed using the Modified Oxford Scale.
|
Baseline and 8 weeks
|
|
Objective incontinence severity
Временное ограничение: Baseline and 8 weeks
|
Objective severity of incontinence will be assessed using a 1-hour pad test.
|
Baseline and 8 weeks
|
|
Patient Global Change (Improvement) Perception Scale
Временное ограничение: In week 8
|
At the end of treatment, women's perceptions of improvement in their urinary incontinence levels will be evaluated using the "Patient Global Improvement Perception Scale".
|
In week 8
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Урогенитальные заболевания
- Мужские мочеполовые заболевания
- Урологические заболевания
- Женские урогенитальные заболевания
- Женские мочеполовые заболевания и осложнения беременности
- Нарушения мочеиспускания
- Симптомы нижних мочевыводящих путей
- Урологические проявления
- Недержание мочи
- Патологические состояния, признаки и симптомы
- Признаки и симптомы
- Недержание мочи, стресс
Другие идентификационные номера исследования
- PT-2026-67
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .