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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study summary

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.

Eligibility

Primary outcome measure(s)

• Sexual function - Erectile Function — 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 - premature ejaculation — 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 - male sexual health — 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 - androgen deficiency — 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 — Baseline and up to 6 months
  satisfaction with treatment of erection problems investigated through EDITS questionnaire (range = 0-100; higher scores =more treatment satisfaction),
• Female sexual function — 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 - sexual distress — Baseline and up to 6 months
  Sexual distress investigated through "Sexual Distress Scale" questionnaire - SDS (range 12- 48, sexual distress = \> 15).

Trial sites (1)

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