PROM Project Urology

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06397287
• Other study ID #: 35-405 ex 22/23
• Status: Recruiting
• Start date: September 5, 2023
• Est. completion date: September 5, 2045

Study information

• Verified date: April 2024
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 47
• Est. completion date: September 5, 2045
• Est. primary completion date: September 5, 2045
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Surgery
• Urologic Cancer
• Urologic Diseases
• Urologic Neoplasms

Intervention

Other:
• Observation of patients undergoing sugery
All 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,

Locations

Country	Name	City	State
Austria	Röthl Martina Anna	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)