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Recruiting NCT06397287

PROM Project Urology

— Observational Surgery Urologic Diseases Urologic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observation of patients undergoing sugery.
Who it may be relevant to
Registry conditions: Surgery, Urologic Diseases, Urologic Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Standardized Collection of Patient Reported Outcomes (PROs) in Everyday Clinical Practice

Overview

All patients undergoing urological surgery or treatment should receive standardized questionnaires on quality of life, satisfaction, pain and physical recovery. Indication-specific, individual pathways are set up, for example, for patients with localized prostate cancer, benign prostate enlargement, bladder dysfunction or erectile dysfunction. In combination with the clinical data, the PROM data should help to improve the quality of the results and, if necessary, adapt treatment pathways to patient needs.

Interventions

  • Other Observation of patients undergoing sugery
    All patients undergoing urological surgery or treatment receive standardized questionnaires on quality of life, satisfaction, pain and physical recovery. Indication-specific, individual pathways are set up,

Primary outcome measures

  • Change in functional treatment outcome in patients with prostate cancer, assessed by EPIC-26: (Expanded Prostate cancer Index Composite) [Time frame: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years]
  • Change in health-related quality of life (PROMIS-10: Patient-Reported Outcomes Measurement Information System) [Time frame: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years]
  • Change in pain: Brief Pain Inventory (BPI) [Time frame: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years]
  • Change in erectile function (IIEF: International Index of Erectile Function) [Time frame: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years]
  • Change in bladder function/micturition (IPSS: International Prostate Symptom Score) [Time frame: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years]
  • Change in bladder function/micturition (OAB-SF: Overactive Bladder Questionnaire, short form) [Time frame: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years]
  • Change in bladder function/micturition (ICIQ-UI: International Consultation on Incontinence Questionnaire-Urinary Incontinence) [Time frame: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years]
  • Change in pelvic pain (NHS-CPSI: Chronic prostatits symptom index) [Time frame: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years]
Secondary outcome measures (8)
  • patient characteristics: age [Time frame: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years]
  • patient characteristics:comorbidities [Time frame: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years]
  • patient characteristics: medication (name, type, dose, interval) [Time frame: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years]
  • patient characteristics: disease-specific data (tumor histology, oncologic status) [Time frame: Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years]
  • Perioperative data: duration of sugery (minutes) [Time frame: during surgery, surgery time depending on the disease (30 minutes to 4 hours)]
  • Perioperative data: blood loss (ml) [Time frame: during surgery, surgery time depending on the disease (30 minutes to 4 hours)]
  • Perioperative data: transfusion (ml [Time frame: during surgery, surgery time depending on the disease (30 minutes to 4 hours)]
  • Perioperative data: length of hospital stay (days) [Time frame: depending on the disease and following surgery (1 to 10 days)]

Eligibility criteria

Inclusion criteria

  • Patients treated at the Department of Urology
  • ≥18 years of age
  • Active Mail-account, use of smartphone/tablet/PC
  • Written informed consent

Exclusion criteria

\- Patients who cannot give written consent and/or do not have digital competence (e.g. no active e-mail account)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Austria · 1 center
  • Röthl Martina Anna — Graz

Identifiers

NCT: NCT06397287 · 35-405 ex 22/23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗