PROM Project Urology

Medical University of Graz47 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Surgery Urologic Diseases Urologic Cancer

Interventions

Observation of patients undergoing sugeryOTHER

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,

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients treated at the Department of Urology 2. ≥18 years of age 3. Active Mail-account, use of smartphone/tablet/PC 4. 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)

Locations (1)

Röthl Martina Anna

Graz, Styria, Austria

RECRUITING

Outcomes

Primary Outcomes

Change in functional treatment outcome in patients with prostate cancer, assessed by EPIC-26: (Expanded Prostate cancer Index Composite)

Electronically recorded Patient Reported Outcomes (PROs) are captured for each patient depending on the condition and surgery/treatment EPIC-26 score: max 100 points; greater values indicate improved functional outcomes

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)

Electronically recorded Patient Reported Outcomes (PROs) are captured for each patient depending on the condition and surgery/treatment. PROMIS-10 max 50 points; greater values indicate healthier 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

Change in pain: Brief Pain Inventory (BPI)

Electronically recorded Patient Reported Outcomes (PROs) are captured for each patient depending on the condition and surgery/treatment. BPI: max. 11 points; greater values indicate worse outcome

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)

Electronically recorded Patient Reported Outcomes (PROs) are captured for each patient depending on the condition and surgery/treatment. IEF: 0-25 points; greater values indicate better ercetile 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)

Electronically recorded Patient Reported Outcomes (PROs) are captured for each patient depending on the condition and surgery/treatment. IPSS: score 0-35; greater values indicates increased symptom severity

Data from ClinicalTrials.gov

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Secondary Outcomes

patient characteristics: age

Clinical parameters are captured for each patient undergoing sugery

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

Clinical parameters are captured for each patient undergoing sugery

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)

Clinical parameters are captured for each patient undergoing sugery

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)

Clinical parameters are captured for each patient undergoing sugery

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)

Perioperative data are captured for each patient undergoing sugery

Time frame: during surgery, surgery time depending on the disease (30 minutes to 4 hours)

Perioperative data: blood loss (ml)

Perioperative data are captured for each patient undergoing sugery

Time frame: during surgery, surgery time depending on the disease (30 minutes to 4 hours)

Perioperative data: transfusion (ml

Perioperative data are captured for each patient undergoing sugery

Time frame: during surgery, surgery time depending on the disease (30 minutes to 4 hours)

Perioperative data: length of hospital stay (days)

Perioperative data are captured for each patient undergoing sugery

Time frame: depending on the disease and following surgery (1 to 10 days)