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NCT Number: NCT06193850

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

IRCCS Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

Location status: Recruiting

Location contact

Alessia d'Arma, MSc

CONTACT

[email protected]

02 2643 5506

About this study

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:

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Observation during time

Other

Evaluation through clinical investigation and questionnaires useful for evaluating the patient's psycho-physical conditions

Primary outcomes

  1. Sexual function - Erectile Function

    Time frame: 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);

  2. Sexual function - premature ejaculation

    Time frame: Baseline and up to 6 months

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

  3. Sexual function - male sexual health

    Time frame: 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);

  4. Sexual function - androgen deficiency

    Time frame: Baseline and up to 6 months

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

  5. Sexual function - satisfaction with treatment of erection problems

    Time frame: Baseline and up to 6 months

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

  6. Female sexual function

    Time frame: 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),;

  7. Sexual function - sexual distress

    Time frame: Baseline and up to 6 months

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

Secondary outcomes

  1. Prostate function - Prostatic Symptoms

    Time frame: Baseline and up to 6 months

    Prostatic Symptoms investigated through IPSS questionnaire "International Prostatic Symptoms Score": , Scoring 0 -7, 0-7 mild symptoms, 8-19 moderate symptoms, 20-35 severe symptoms

  2. Psychological state

    Time frame: Baseline and up to 6 months

    Psychological state investigated through Beck Beck Depression Inventory: Range score 1 - 63; 1-10: normal; 11-16: Mild mood disturbance; 17-20: Borderline clinical depression; 21-30: Moderate depression; 31-40: Severe depression; over 40: Extreme depression.

  3. Prostate function - Incontinence Questionnaire

    Time frame: Baseline and up to 6 months

    Incontinence Questionnaire investigated through ICIQ-SF questionnaire (maximum score of 21; the higher the score, the more severe is the UI, but there is no normal score)

  4. Overactive Bladder

    Time frame: Baseline and up to 6 months

    Overactive Bladder investigated through OAB-q - Overactive Bladder Questionnaire: the score for each of OAB-q domain are summed and transformed to a score ranging from zero to 100. Higher scores indicate more severe symptoms or better quality of life.

  5. Prostate function

    Time frame: Baseline and up to 6 months

    Prostate function investigated through National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) questionnaire: total score range from 0 to 43, three subscales addressing pain (score range 0-21), urinary symptoms (score range 0-10), and quality of life (QOL) (score range 0-12)

Study contacts

Contact information is provided by the study sponsor or research team.

Alessia d'Arma, PhD

CONTACT

[email protected]

02 2643 5506

Andrea Salonia, MD

CONTACT

[email protected]

02 2643 5661

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2025
Study completion
2045
First posted
Jan 5, 2024
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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