Clinical trial NCT06397287: PROM Project Urology
Official title: Standardized Collection of Patient Reported Outcomes (PROs) in Everyday Clinical Practice
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgery
Urologic Diseases
Urologic Cancer
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated at the Department of Urology

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.


Eligibility criteria: 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)

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