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Идёт набор NCT06193850

Protocol N. 2014 - Observational Study on the Quality of Life of Outpatients

Наблюдательное Urologic Diseases Male Infertility Sexual Medicine

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: Observation during time.
Кому может быть актуально
Состояния в реестре: Urologic Diseases, Male Infertility, Sexual Medicine. 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
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Observational Study on the Quality of Life of Patients Attending General Urology, Sexual Medicine, Reproductive Medicine, Uro-oncology, Neuro-urology, Functional Urology Clinics

Обзор

Prospective observational study on the quality of life of patients attending general urology, sexual medicine, reproductive medicine, functional urology, neuro-urology and uro-oncology clinics.The data relating to the clinical conditions (disease state, psychological and related to quality of life) of the patients belonging to the above-mentioned clinics will be collected in a specially designed database which will allow us to extract the data in a simple and safe way used for statistical analyses. in clinical research.

Подробное описание

The Department of Urology has been engaged for years in the field of medical and surgical research relating to benign and oncological pathologies of the prostate, kidney, excretory tract, testicle, as well as urinary continence and dysfunctions of the sexual and reproductive sphere. The accurate acquisition of clinical and psychometric data before and after any treatment, the follow-up analysis, the attention to the patient's global quality of life (QoL) in relation to the particular organic functions affected by the disease, are at the basis of all the medical advances that can be achieved to guarantee ever better care of the individual's health. In the context of urological clinical practice, outpatient activity plays a fundamental role. This activity, which ranges from general urology to sexual medicine, reproductive medicine, functional urology, neuro-urology and uro-oncology, allows us to come into contact with a large number of patients suffering from the most common uropathologies -andrological .

Numerous studies have demonstrated how the treatment and outpatient management of such patients significantly impacts not only the underlying pathology but also their quality of life.

The outpatient management of the urological patient ranges from the recognition of the basic pathology to the diagnosis through the request for clinical-laboratory-instrumental investigations, to the possible indication for a medical or surgical treatment and to the follow-up of the patient.

The main objectives of this data archive are:

1. Collect clinical, instrumental, laboratory, psychometric and sociodemographic data in patients suffering from a uro-andrological pathology who require a consultation in one of the clinics mentioned above. 2. Collect data on the natural history of the pathologies in question and on the patients' quality of life in order to analyze the predictive factors of persistence and recurrence of symptoms, improvement or worsening of the clinical picture, and possible progression of the disease (both in benign and malignant form) and improve the care and treatment of the patients under examination. 3. Having a follow-up and related studies with a number and above all an extension over time that, to date, is not present in the literature or in any scientific production.

Вмешательства

  • Другое Observation during time
    Evaluation through clinical investigation and questionnaires useful for evaluating the patient's psycho-physical conditions

Первичные конечные точки

  • Sexual function - Erectile Function [Срок оценки: Baseline and up to 6 months]
  • Sexual function - premature ejaculation [Срок оценки: Baseline and up to 6 months]
  • Sexual function - male sexual health [Срок оценки: Baseline and up to 6 months]
  • Sexual function - androgen deficiency [Срок оценки: Baseline and up to 6 months]
  • Sexual function - satisfaction with treatment of erection problems [Срок оценки: Baseline and up to 6 months]
  • Female sexual function [Срок оценки: Baseline and up to 6 months]
  • Sexual function - sexual distress [Срок оценки: Baseline and up to 6 months]
Вторичные конечные точки (5)
  • Prostate function - Prostatic Symptoms [Срок оценки: Baseline and up to 6 months]
  • Psychological state [Срок оценки: Baseline and up to 6 months]
  • Prostate function - Incontinence Questionnaire [Срок оценки: Baseline and up to 6 months]
  • Overactive Bladder [Срок оценки: Baseline and up to 6 months]
  • Prostate function [Срок оценки: Baseline and up to 6 months]

Критерии участия

Критерии включения

  • subjects belonging to general urology, sexual medicine, reproductive medicine, functional urology, neuro-urology and uro-oncology clinics.
  • subjects >= 18 years old
  • signature of informed consent

Критерии исключения

  • \- subjects < 18 years
  • presence of mental or physical disability that may prevent the patient from answering the questionnaires.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • IRCCS Ospedale San Raffaele — Milan

Идентификаторы

NCT: NCT06193850 · 2014 Ambulatoriali

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗