Clinical Evaluation of the Femiset Device for Perineal Descent in Women

Официальное название

Clinical Evaluation of the Femiset Device for Perineal Descent in Women - Impact on Stool Evacuation

Обзор

The University of Antwerp developed a device (Femiset) to alleviate defecation difficulties in women suffering from Descending Perineum Syndrome (DPS). The device allows the patient to apply counterpressure to the site of descent (perineal body) during defecation, thereby correcting the excessive descent of the perineum so that the increase in abdominal pressure during the (attempted) defecation results in the evacuation of the stool from the rectum and anus, rather than a further downward pressure on the already descended perineum. The aim of the clinical study is to validate the efficacy (improvement in defecation) and safety of Femiset as compared to the standard of care of no support to the perineum through a clinical study on 20 patients. The population to be studied consists of adult women suffering from DPS with symptoms of obstructive defecation. Patients will use the device in their home environment for four weeks. The improvement in defecation as perceived by the patient will be assessed with the Patient Global Impression of Change (PGIC) scale. Secondarily, their ODS symptoms will be assessed prior to the test period and at the end of the test period using the Modified Longo Score for ODS. These scores will be compared to determine if there has been an improvement in ODS symptoms. The safety of the device will be validated based on monitoring the incidence of adverse events during the test period. The study will also explore the usability of the device and how it compares to manual perineal support. The results of the study will determine the product's viability.

Вмешательства

• Устройство Use device in home environment
  Patients will use the device in their home environment for four weeks.

Первичные конечные точки

• Efficacy - improvement in defecation [Срок оценки: 4 weeks]
• Safety - incidence of adverse events [Срок оценки: 4 weeks]

Вторичные конечные точки (1)

• Efficacy - improvement in ODS symptoms [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

• Woman at birth
• Adult (aged 18+)
• ODS complaints
• MRI has been performed within the past three years and a perineal descent of >4cm on MRI (M-Line) is present
• Functional pelvic floor (no dyssynergia)

Критерии исключения

• Scoring less than 7/24 on the modified Longo Score for ODS
• Need for vaginal splinting
• Severe perineal malformations
• Recent perineal surgery (<6 weeks)
• Recent vaginal delivery (<6 weeks)
• Pregnant or actively trying to conceive
• Known allergy to the material of the investigational device
• Inability to follow instructions or handle the device
• Not able to understand the language of the questionnaires (NL/English)
• Incapable of giving informed consent

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07039188 · 3975

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗