PROM Project Urology

Standardized Collection of Patient Reported Outcomes (PROs) in Everyday Clinical Practice

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 Overview

• Status: Recruiting
• Conditions: Urologic Diseases; Surgery; Urologic Cancer
• Intervention / Treatment: Other: Observation of patients undergoing sugery

• Study Type: Observational
• Enrollment (Estimated): 47

Contacts and Locations

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8036
      • Recruiting
      • Röthl Martina Anna
      • Contact: Marianne Leitsmann, Prof. Dr.; Phone Number: +43 316 385 80550; Email: martina.roethl@medunigraz.at
      • Principal Investigator: Marianne Leitsmann, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients treated at the Department of Urology

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years
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	Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years
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	Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years
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	Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years
Change in bladder function/micturition (IPSS: International Prostate Symptom Score)	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	Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years
Change in bladder function/micturition (OAB-SF: Overactive Bladder Questionnaire, short form)	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	Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years
Change in bladder function/micturition (ICIQ-UI: International Consultation on Incontinence Questionnaire-Urinary Incontinence)	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	Data collection/follow-up: day - 1 before surgery, 2 to 10 days host surgery, after 3, 6, 12 months, annually 2 to 10 years
Change in pelvic pain (NHS-CPSI: Chronic prostatits symptom index)	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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient characteristics: age	Clinical parameters are captured for each patient undergoing sugery	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	Clinical parameters are captured for each patient undergoing sugery	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: medication (name, type, dose, interval)	Clinical parameters are captured for each patient undergoing sugery	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)	Clinical parameters are captured for each patient undergoing sugery	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)	Perioperative data are captured for each patient undergoing sugery	during surgery, surgery time depending on the disease (30 minutes to 4 hours)
Perioperative data: blood loss (ml)	Perioperative data are captured for each patient undergoing sugery	during surgery, surgery time depending on the disease (30 minutes to 4 hours)
Perioperative data: transfusion (ml	Perioperative data are captured for each patient undergoing sugery	during surgery, surgery time depending on the disease (30 minutes to 4 hours)
Perioperative data: length of hospital stay (days)	Perioperative data are captured for each patient undergoing sugery	depending on the disease and following surgery (1 to 10 days)

Collaborators and Investigators

• Sponsor: Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2023
• Primary Completion (Estimated): September 5, 2045
• Study Completion (Estimated): September 5, 2045

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Neoplasms; Urologic Diseases
• Other Study ID Numbers: 35-405 ex 22/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No