Central Sensitization Inventory and Symptoms of Pelvic Floor Dysfunctions
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Pelvic Floor Dysfunctions. Базовые параметры: 18 лет — 80 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
- Польша
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The goal of this observational study is to assess the values of Central Sensitization Inventory in women in a gynecology outpatient clinic. The main question it aims to answer is: Is there a relationship between outcomes of Central Sensitization Inventory and symptoms of pelvic floor dysfunctions reported by the patients? Participants will complete questionnaires: Central Sensitization Inventory and questionnaires assessing pelvic floor dysfunctions and their impact on quality of life (PFDI-20, PFIQ-7, PISQ-12).
Подробное описание
Background: Pelvic floor dysfunctions are common disorders negatively impacting women's quality of life. However, there are differences when assessing prevalence due to the type of assessment. Prevalence of pelvic organ prolapse ranges between 1-65% of women; when assessing prevalence depending on symptoms, it can be 1-31%, but using anatomical examination, 1-50%, and finally, both of them - 20-65%.
Factors that are responsible for these discrepancies are still unknown. There are suggestions about correlations between central sensitivity syndrome (CSS) and differences in symptoms reported by patients, and the effect of surgical treatment.
Objectives: The aim of this study is to assess the values of Central Sensitization Inventory in women in gynecology outpatient clinic. Moreover, to examine if there is a relationship between those outcomes and symptoms of pelvic floor dysfunctions reported by the patients.
Material and methods: Women attending gynecological outpatient clinics will be invited to this study. Participants will be asked to complete the following questionnaires: Central Sensitization Inventory (CSI) and questionnaires assessing pelvic floor dysfunctions and their impact on quality of life (PFDI-20, PFIQ-7, PISQ-12). Pelvic organ prolapse will be assessed using the POP-Q scale.
Expected results: To our knowledge, this will be the first study of this type conducted in Poland. Obtained results will provide preliminary, descriptive information on values of the Central Sensitization Inventory and questionnaires assessing pelvic floor dysfunctions and their impact on quality of life. Data from this study may become a starting point for further, larger projects aimed at improving treatment of pelvic floor dysfunctions, including both physiotherapy and surgical treatment.
Первичные конечные точки
- Central Sensitization Inventory (CSI) [Срок оценки: baseline measurement]
- Polish version of the Pelvic Floor Distress Inventory (PFDI-20) [Срок оценки: baseline measurement]
- Pelvic Organ Prolapse Quantification (POP-Q) system [Срок оценки: baseline measurement]
- Polish version of the Pelvic Floor Impact Questionnaire short form 7 (PFIQ-7) [Срок оценки: baseline measurement]
- Polish version of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) [Срок оценки: baseline measurement]
Критерии участия
Критерии включения
- women attending gynecological outpatient clinics
- Agreement to participate
- Good command of spoken and written Polish
Критерии исключения
- age below 18
- women who have undergone surgical treatment of pelvic organ prolapse or urinary incontinence
- Lack of consent to participate in the study
- Lack of good command of spoken and written Polish
- pregnancy
- women up to 6 months postpartum
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Польша · 1 центр
- Żelazna Medical Center — Warsaw
Идентификаторы
NCT: NCT07154576 · PN/99/2024