Surgery, Urologic Cancer, Urologic Diseases
Conditions
Brief summary
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
OTHERObservation 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,
Sponsors
Medical University of Graz
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pelvic pain (NHS-CPSI: Chronic prostatits symptom index) | Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years | Electronically recorded Patient Reported Outcomes (PROs) are captured for each patient depending on the condition and surgery/treatment. NHS-CSI: 0-43 points; greater values indicate worse outcomes |
| Change in functional treatment outcome in patients with prostate cancer, assessed by EPIC-26: (Expanded Prostate cancer Index Composite) | Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years | 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 |
| Change in health-related quality of life (PROMIS-10: Patient-Reported Outcomes Measurement Information System) | Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years | 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 |
| Change in pain: Brief Pain Inventory (BPI) | Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years | 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 |
| Change in erectile function (IIEF: International Index of Erectile Function) | Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years | 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 |
| Change in bladder function/micturition (IPSS: International Prostate Symptom Score) | Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years | 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 |
| Change in bladder function/micturition (OAB-SF: Overactive Bladder Questionnaire, short form) | Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years | Electronically recorded Patient Reported Outcomes (PROs) are captured for each patient depending on the condition and surgery/treatment. OAB-SF: score 0 - 16; score with greater values indicates increased symptom severity |
| Change in bladder function/micturition (ICIQ-UI: International Consultation on Incontinence Questionnaire-Urinary Incontinence) | Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years | Electronically recorded Patient Reported Outcomes (PROs) are captured for each patient depending on the condition and surgery/treatment. ICIQ-UI: score 0-21; greater values indicate worse urinary incontinence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| patient characteristics: age | Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years | Clinical parameters are captured for each patient undergoing sugery |
| patient characteristics:comorbidities | Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years | Clinical parameters are captured for each patient undergoing sugery |
| patient characteristics: medication (name, type, dose, interval) | Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years | Clinical parameters are captured for each patient undergoing sugery |
| patient characteristics: disease-specific data (tumor histology, oncologic status) | Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years | Clinical parameters are captured for each patient undergoing sugery |
| Perioperative data: duration of sugery (minutes) | during surgery, surgery time depending on the disease (30 minutes to 4 hours) | Perioperative data are captured for each patient undergoing sugery |
| Perioperative data: blood loss (ml) | during surgery, surgery time depending on the disease (30 minutes to 4 hours) | Perioperative data are captured for each patient undergoing sugery |
| Perioperative data: transfusion (ml | during surgery, surgery time depending on the disease (30 minutes to 4 hours) | Perioperative data are captured for each patient undergoing sugery |
| Perioperative data: length of hospital stay (days) | depending on the disease and following surgery (1 to 10 days) | Perioperative data are captured for each patient undergoing sugery |
Countries
Austria
Outcome results
None listed