PROM Project Urology
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical University of Graz
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients treated at the Department of Urology
≥18 years of age
Active Mail-account, use of smartphone/tablet/PC
Written informed consent
Disqualifiers
None
Trial population
Patients treated at the Department of Urology
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observation of patients undergoing sugery
Other interventionAll 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,
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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 years2
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 years3
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 years4
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 yearsSecondary outcomes
1
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 years2
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 years3
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 years4
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 yearsSponsors and contacts
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Source ClinicalTrials.gov