Röthl Martina Anna
Graz, Styria, 8036, Austria
Location status: Recruiting
Location contact
Marianne Leitsmann, Prof. Dr.
CONTACT
Marianne Leitsmann, Prof. Dr.
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT06397287
PROM Project Urology
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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)
Treatment and study plan
Observation of patients undergoing sugery
OtherAll 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,
Primary outcomes
-
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 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 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 (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 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 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
-
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
Secondary outcomes
-
patient characteristics: age
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
Clinical parameters are captured for each patient undergoing sugery
-
patient characteristics:comorbidities
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
Clinical parameters are captured for each patient undergoing sugery
-
patient characteristics: medication (name, type, dose, interval)
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
Clinical parameters are captured for each patient undergoing sugery
-
patient characteristics: disease-specific data (tumor histology, oncologic 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
Clinical parameters are captured for each patient undergoing sugery
-
Perioperative data: duration of sugery (minutes)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: depending on the disease and following surgery (1 to 10 days)
Perioperative data are captured for each patient undergoing sugery
Sponsors and collaborators
Lead sponsor
Medical University of Graz
Other
Registry information
Official study title
Standardized Collection of Patient Reported Outcomes (PROs) in Everyday Clinical Practice
Important dates
- Study start
- 2023
- Primary completion
- 2045
- Study completion
- 2045
- First posted
- May 2, 2024
- Registry last updated
- May 2, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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