Patient Education in the Clinical Management of Pessary

Официальное название

A Randomized Controlled Trial of the Effectiveness of Patient Education in the Clinical Management of Pessary

Обзор

This study is a prospective, randomized, controlled, single-blinded, multi-center clinical trial. Symptomatic patients with pelvic organ prolapse (POP) stage II, III or IV arranged to undergo pessary treatment will be randomized into either the experimental group or the control group. All patients will receive conventional verbal/paper instruction and counseling from a specialized doctor or nurse before pessary fitting, and the experimental group will receive additional patient education in the form of a re-watchable video. The video mainly includes a short introduction of pessary treatment for pelvic organ prolapse, tips and tricks for wearing and self-management of pessary, possible adverse reactions and remedy. All patients will receive regular pessary fitting and be followed up for 1 year. Self-assessment questionnaires will be used to assess the patients' willingness to pessary treatment, anxiety status, treatment satisfaction and efficacy, and to assess the patients' self-management, complications and treatment adherence. Then the differences between the two groups will be compared.

Вмешательства

• Другое video education
  A re-watchable video provided before pessary fitting which mainly includes a short introduction of pessary treatment for pelvic organ prolapse, tips and tricks for wearing and self-management of pessary, possible adverse reactions and remedy.
• Другое conventional education
  Conventional verbal/paper instruction and counseling from a specialized doctor or nurse before pessary fitting.

Первичные конечные точки

• Continued usage with satisfaction [Срок оценки: 12 months after pessary fitting.]

Вторичные конечные точки (8)

• Knowledge of pessary [Срок оценки: Baseline and at pessary fitting.]
• Willingness to treatment [Срок оценки: Baseline, at pessary fitting, and 3 and 12 months after successful pessary fitting.]
• Anxiety about pessary use [Срок оценки: Baseline and at pessary fitting.]
• Ability to self-manage [Срок оценки: 3 and 12 months after successful pessary fitting.]
• Treatment-related symptoms and complications [Срок оценки: 3 and 12 months after successful pessary fitting.]
• Improvement in symptoms [Срок оценки: 3 and 12 months after successful pessary fitting.]
• Improvement in quality of life [Срок оценки: 3 and 12 months after successful pessary fitting.]
• Improvement in sexual activity [Срок оценки: 3 and 12 months after successful pessary fitting.]

Критерии участия

Критерии включения

• Symptomatic pelvic organ prolapse of stage II\~IV
• Ability to participate in clinical trial and follow-up
• The patient and family understand the study, are willing to participate in the 1-year study, and provide written informed consent

Критерии исключения

• Acute phase of infection of the internal and/or external genital tracts
• Genital fistula
• Suspected or untreated lower genital tract tumors
• Abnormally elevated intra-abdominal pressure (e.g., ascites, tumors)
• Life expectancy less than 1 year
• Cognitive or language communication disorders
• Unable to watch video (e.g., blindness)

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking Union Medical College Hospital — Пекин

Идентификаторы

NCT: NCT06432218 · K5558

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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