Набор по приглашению NCT07693647

Evaluation of Pelvic Floor Function and Psychosocial Sequelae Following Radical Prostatectomy for Prostate Cancer

— Наблюдательное Prostate Cancer (Adenocarcinoma) Radical Prostatectomy Urinary Incontinence (UI) Erectile Dysfunction Following Radical Prostatectomy

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: No Interventions.
Кому может быть актуально: Состояния в реестре: Prostate Cancer (Adenocarcinoma), Radical Prostatectomy, Urinary Incontinence (UI), Erectile Dysfunction Following Radical Prostatectomy. Базовые параметры: от 18 лет · Мужчины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Испания
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

Evaluation of Urinary Incontinence, Erectile Dysfunction, and Psychosocial Outcomes Following Radical Prostatectomy for Prostate Cancer

Обзор

This observational cross-sectional study aims to evaluate the effects of radical prostatectomy for prostate cancer on pelvic floor function and psychosocial well-being. The study will assess the prevalence and severity of urinary incontinence and erectile dysfunction, as well as their impact on quality of life, sexual health, self-esteem, and interpersonal relationships. Adult men who underwent radical prostatectomy at least one year before enrollment will complete a series of validated questionnaires and provide demographic and clinical information through online surveys or telephone interviews. The study will also explore whether participants received pelvic floor physiotherapy before or after surgery and whether rehabilitation is associated with better functional and psychosocial outcomes. The findings may contribute to a better understanding of the long-term consequences of radical prostatectomy and help identify opportunities to improve patient care.

Подробное описание

Radical prostatectomy is one of the most common curative treatments for localized prostate cancer. Although surgical techniques have improved over recent decades, urinary incontinence and erectile dysfunction remain among the most frequent long-term complications after surgery. These conditions may substantially affect patients' quality of life, sexual health, self-esteem, interpersonal relationships, and psychosocial well-being. Despite the availability of conservative pelvic floor rehabilitation strategies, access to and use of pelvic floor physiotherapy before and after surgery remain variable.

This observational cross-sectional study aims to evaluate the long-term effects of radical prostatectomy on pelvic floor function and psychosocial outcomes in men who underwent surgery at least one year before study participation. Data will be collected through validated patient-reported outcome measures and a structured questionnaire including sociodemographic, clinical, and treatment-related information.

Participants will be recruited through social media, institutional dissemination, patient networks, and snowball sampling. After providing electronic informed consent, participants will complete the study questionnaires either online or, when digital literacy is limited, through a structured telephone interview conducted by a trained researcher. No interviews will be audio-recorded, and all data will be pseudonymized before analysis.

The primary objectives are to evaluate urinary incontinence and erectile dysfunction after radical prostatectomy and to describe their psychosocial consequences. Secondary objectives include determining the proportion of patients who received information about pelvic floor physiotherapy, identifying the proportion who underwent pelvic floor rehabilitation before and/or after surgery, and exploring whether rehabilitation is associated with differences in functional and psychosocial outcomes. The study also aims to improve awareness of pelvic floor rehabilitation as part of the multidisciplinary management of prostate cancer survivors.

Вмешательства

Другое No Interventions
No intervention

Первичные конечные точки

Erectile dysfunction [Срок оценки: Baseline (single assessment)]
Urinary incontinence severity [Срок оценки: Baseline (single assessment)]

Вторичные конечные точки (9)

Prostate cancer-specific urinary symptoms and quality of life [Срок оценки: Baseline (single assessment)]
Sexual health [Срок оценки: Baseline (single assessment)]
Self-esteem and relationship outcomes [Срок оценки: Baseline (single assessment)]
Health-related quality of life [Срок оценки: Baseline (single assessment)]
Pelvic floor physiotherapy [Срок оценки: Baseline (single assessment)]
Comfort discussing urinary incontinence [Срок оценки: Baseline (single assessment)]
Comfort discussing sexual health [Срок оценки: Baseline (single assessment)]
Perceived influence of social taboos [Срок оценки: Baseline (single assessment)]
Honesty of questionnaire responses [Срок оценки: Baseline (single assessment)]

Критерии участия

Критерии включения

Male participants aged 18 years or older. History of radical prostatectomy for prostate cancer, regardless of the surgical technique used.

At least 12 months since radical prostatectomy. Able to understand the study information and provide electronic informed consent.

Able to complete the questionnaires in Spanish, either independently or with the support of a structured telephone interview.

Willing to participate voluntarily in the study.

Критерии исключения

Presence of comorbidities that may independently contribute to urinary incontinence or erectile dysfunction (e.g., neurological disorders or other relevant medical conditions).

Severe cognitive or sensory impairment that prevents understanding the study procedures or completing the questionnaires.

Refusal or inability to provide informed consent.

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

Здоровые добровольцы: Да