Набор скоро начнётся NCT07399509

Evaluation of Sexual Function After Artificial Urinary Sphincter Implantation

— Наблюдательное Female Artificial Urinary Sphincter Implantation

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: questionnaires.
Кому может быть актуально: Состояния в реестре: Female Artificial Urinary Sphincter Implantation. 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: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Prospective Observational Study Evaluating the Sexual Function After Insertion of an Artificial Urinary Sphincter in Women

Обзор

Urinary incontinence (UI) is a common and disabling condition that affects millions of people worldwide and significantly impacts the quality of life of those affected. It is well established that urinary incontinence negatively affects sexual life. Although there is no definitive consensus yet, many authors report that sexual function, after surgical intervention to restore continence, is likely to improve or, at the very least, remain unchanged.

Подробное описание

The primary objective of the study is to evaluate sexual function in women 6 months after implantation of an artificial urinary sphincter.

Patients will be informed during the preoperative consultation, with an information sheet provided. Consent to non-opposition will be collected either during the preoperative consultation or on the day of the procedure, if additional time for reflection is needed. Questionnaires will be completed during follow-up visits at 6 and 12 months postoperatively.

The patients concerned are women who have undergone implantation of an artificial urinary sphincter.

Вмешательства

Другое questionnaires
The PISQ-12 questionnaire, which explores female sexual function; the ICIQ-FLUTSsex questionnaire, which focuses on the impact of urinary leakage on sexuality; the USP questionnaire, which assesses the frequency and characteristics of urinary incontinence; and the Qualiveen-SF questionnaire, which measures the impact of these urinary disorders on daily life. A bladder diary was completed preoperatively as well as during follow-up visits at 6 and 12 months.

Первичные конечные точки

Assess sexual function [Срок оценки: 6 months]

Вторичные конечные точки (6)

Assess sexual function [Срок оценки: 12 months]
Assess sexual quality of life [Срок оценки: 6 and 12 months]
Assess urinary incontinence (clinical efficacy) [Срок оценки: 6 and 12 months]
Assess urinary incontinence (clinical efficacy) [Срок оценки: 6 and 12 months]
Assess quality of life [Срок оценки: 6 and 12 months]
Assess complications [Срок оценки: 6 and 12 months]

Критерии участия

Критерии включения

Women aged 18 to 80 years
Patients with from urinary incontinence with an appropriate surgical indication for artificial urinary sphincter implantation
Patients who accept the surgical indication and have signed the informed consent for the procedure
No objection from the patients to participate in the study after reading the information sheet