PROM Project Urology

Recruiting

• Conditions: Surgery; Urologic Diseases; Urologic Cancer

• Registration Number: NCT06397287
• Lead Sponsor: Medical University of Graz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-05
• Study First Submitted: 2024-03-28
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-29
• Last Update Submitted: 2024-04-29
• Study First Posted: 2024-05-02
• Last Update Posted: 2024-05-02
• Primary Completion: 2045-09-05
• Study Completion: 2045-09-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 47

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in bladder function/micturition (IPSS: International Prostate Symptom Score)	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)	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)	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)	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)	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)	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)	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)	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 Outcome Measures

Name	Time	Method
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	Clinical parameters are captured for each patient undergoing sugery
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	Clinical parameters are captured for each patient undergoing sugery
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	Clinical parameters are captured for each patient undergoing sugery
Perioperative data: duration of sugery (minutes)	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)	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	during surgery, surgery time depending on the disease (30 minutes to 4 hours)	Perioperative data are captured for each patient undergoing sugery
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	Clinical parameters are captured for each patient undergoing sugery
Perioperative data: length of hospital stay (days)	depending on the disease and following surgery (1 to 10 days)	Perioperative data are captured for each patient undergoing sugery

Trial Locations

Locations (1)

Röthl Martina Anna; 🇦🇹 Graz, Styria, Austria