Standardized Collection of Patient Reported Outcomes (PROs) in Everyday Clinical Practice
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Change in bladder function/micturition (IPSS: International Prostate Symptom Score)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
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
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 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
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)
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
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 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
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 (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
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 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
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 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
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 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
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 Outcomes
- 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)
- 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)
- 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)
- Perioperative data: duration of sugery (minutes)(during surgery, surgery time depending on the disease (30 minutes to 4 hours))
- Perioperative data: blood loss (ml)(during surgery, surgery time depending on the disease (30 minutes to 4 hours))
- Perioperative data: transfusion (ml(during surgery, surgery time depending on the disease (30 minutes to 4 hours))
- 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)
- Perioperative data: length of hospital stay (days)(depending on the disease and following surgery (1 to 10 days))