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Идёт набор NCT04701047

Prospective Observational Prolapse Study

Наблюдательное Vaginal Prolapse

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: vaginal pessary, Vaginal prolapse surgery.
Кому может быть актуально
Состояния в реестре: Vaginal Prolapse. Базовые параметры: от 18 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
Бельгия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Prospective Observational Study with Patient Reported Outcome Measures (PROM) for the Treatment of Vaginal Prolapse: Pessary Vs. Surgery

Обзор

The rationale of the study is to investigate the results of a prolapse treatment in adult women with a vaginal prolapse. The investigators will investigate this by taking questionnaires in women undergoing a surgical prolapse repair and in women that are being treated by a vaginal pessary. The objective is to compare the results of the different methods with each other and to observe the evolution of the symptoms in patients undergoing surgery or pessary use. The investigators would also like to discover existing problems in pessary use and adverse effects.

Подробное описание

The rationale of the study is to investigate the results of a prolapse treatment in adult women with a vaginal prolapse. The investigators will investigate this by taking questionnaires in women undergoing a surgical prolapse repair and in women that are being treated by a vaginal pessary. The objective is to compare the results of the different methods with each other and to observe the evolution of the symptoms in patients undergoing surgery or pessary use. The investigators would also like to discover existing problems in pessary use and adverse effects.

The questionnaires that will be used are the PFDI-20 (pelvic floor distress inventory), PFIQ-7 (pelvic floor impact questionnaire), PISQ-9 (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire) and a custom-made questionnaire to further investigate the behavior towards pessary use of our patients and the adverse effects they are dealing with. The questionnaires will be taken before the treatment has started, 6 weeks post treatment start, one-year post treatment start, two years post treatment start and 5 years post treatment start. A POP-Q (Pelvic Organ Prolapse Quantification) investigation will be performed to estimate the degree of vaginal prolapse before the start of the treatment. Since clinical follow up is not necessarily needed after one year for the women who undergo surgery, their questionnaires will be taken via telephone or e-mail. For women that are being treated with pessaries the investigators will also take our custom-made questionnaire at 4 and 8 months after starting the treatment.

The investigators would like to recruit 100 women for this study, older than 18 years old who have not undergone a previous treatment with a pessary or surgery for vaginal prolapse. Another exclusion criterium are women who still have a child wish and women who have contraindications for surgery. The investigators will also exclude women who don't speak Dutch or women who cannot give a written consent.

The investigators hypothesize that woman being treated with one year of pessary use are overall not having more symptoms than woman that underwent a surgery. The investigators hypothesize that woman being treated with five years of pessary use are overall having less symptoms than woman that underwent a surgery.

Вмешательства

  • Устройство vaginal pessary
    insertion and follow up of a vaginal pessary
  • Процедура Vaginal prolapse surgery
    surgery and follow up after vaginal prolapse surgery

Первичные конечные точки

  • Change in Pelvic Floor Disability Index (PFDI-20) [Срок оценки: Baseline, 6 weeks, one year, two years, five years]
  • Change in pelvic floor impact questionnaire (PFIQ-7) [Срок оценки: Baseline, 6 weeks, one year, two years, five years]
  • Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) [Срок оценки: Baseline, 6 weeks, one year, two years, five years]
Вторичные конечные точки (6)
  • Subjective self-reported satisfaction scores for pessary use as measured via a custom-made Likert scale questionnaire [Срок оценки: 4 months after start of therapy]
  • Subjective self-reported satisfaction scores for pessary use as measured via a custom-made Likert scale questionnaire [Срок оценки: 8 months after start of therapy]
  • Self-reported behavior and patient preferences towards pessary use via a custom-made questionnaire [Срок оценки: 4 months after initiation of therapy]
  • Self-reported behavior and patient preferences towards pessary use via a custom-made questionnaire [Срок оценки: 8 months after initiation of therapy]
  • Subjective self-reported adverse effects of pessary use as measured via a custom-made questionnaire [Срок оценки: 4 months after initiation of therapy]
  • Subjective self-reported adverse effects of pessary use as measured via a custom-made questionnaire [Срок оценки: 8 months after initiation of therapy]

Критерии участия

Критерии включения

  • women with a symptomatic vaginal prolapse
  • older than 18 years

Критерии исключения

  • under 18 years old
  • undergone a previous treatment with a pessary or surgery for vaginal prolapse
  • contra-indications for surgery or pessary use
  • active or passive child wish
  • not able to understand the Dutch language
  • not able to give a written consent

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Бельгия · 1 центр
  • Ghent University Hospital — Ghent

Идентификаторы

NCT: NCT04701047 · BC-08720-ADP

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗