跳至主要内容
临床试验/NCT06193850
NCT06193850招募中不适用

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

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2015年2月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10,000
试验地点
1
主要终点
Female sexual function

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Female sexual function

时间窗: Baseline and up to 6 months

Female sexual function investigated through "Female Sexual Function Index" questionnaire - FSFI (range 2 - 36, lower scores = worse sexual functioning),;

Sexual function - Erectile Function

时间窗: Baseline and up to 6 months

Sexual function investigated through: "International Index of Erectile Function" questionnaire IIEF (scoring: 1 - 30 - 6-10: severe; 11-16: Moderate; 17-25: mild; 26-30: absence);

Sexual function - male sexual health

时间窗: Baseline and up to 6 months

Male sexual health investigated through MSHQ questionnaire (25-item, range: 7 - 80, greater score indicating better function and through Androtest (1 - 32; \> 8 = out of the norm);

Sexual function - premature ejaculation

时间窗: Baseline and up to 6 months

Premature ejaculation investigated through PEDT questionnaire (; Scoring: 0 - 20. \<=8 absence; 9-10 probable; \>=11 premature ejaculation);

Sexual function - androgen deficiency

时间窗: Baseline and up to 6 months

Androgen deficiency in elderly males investigated through ADAM questionnaire (range 10 - 50, 10 = absence and 50 = maximal,

Sexual function - satisfaction with treatment of erection problems

时间窗: Baseline and up to 6 months

satisfaction with treatment of erection problems investigated through EDITS questionnaire (range = 0-100; higher scores =more treatment satisfaction),

Sexual function - sexual distress

时间窗: Baseline and up to 6 months

Sexual distress investigated through "Sexual Distress Scale" questionnaire - SDS (range 12- 48, sexual distress = \> 15).

次要结局

  • Prostate function - Incontinence Questionnaire(Baseline and up to 6 months)
  • Prostate function - Prostatic Symptoms(Baseline and up to 6 months)
  • Overactive Bladder(Baseline and up to 6 months)
  • Psychological state(Baseline and up to 6 months)
  • Prostate function(Baseline and up to 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Salonia

Professor

IRCCS San Raffaele

研究点 (1)

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