PROM Project Urology

NCT06397287 | Recruiting DMC

• 1 other identifier: 35-405 ex 22/23
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Urologic Diseases; Urologic Cancer

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (8)

• 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: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

• 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

• 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

• Perioperative data: duration of sugery (minutes)

  during surgery, surgery time depending on the disease (30 minutes to 4 hours)

Interventions

Observation of patients undergoing sugery OTHER

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,

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Specific urologic diseases are dependent on gender
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated at the Department of Urology

You may qualify if:

• Patients treated at the Department of Urology
• ≥18 years of age
• Active Mail-account, use of smartphone/tablet/PC
• Written informed consent

You may not qualify if:

• \- Patients who cannot give written consent and/or do not have digital competence (e.g. no active e-mail account)

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Röthl Martina Anna

Graz, Styria, 8036, Austria

RECRUITING

MeSH Terms

Conditions

Urologic Diseases; Urologic Neoplasms

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: May 2, 2024
• Study Start: September 5, 2023
• Primary Completion (Estimated): September 5, 2045
• Study Completion (Estimated): September 5, 2045
• Last Updated: May 2, 2024

Record last verified: 2024-04

Locations

AU (1)