Exploration of HRQOL and Urinary Outcomes Following Partial Cystectomy

Recruiting

• Conditions: Bladder Carcinoma

• Registration Number: NCT06891209
• Lead Sponsor: Mayo Clinic

Brief Summary

This study explores and compares health-related quality of life and urinary outcomes in postoperative partial cystectomy and matched radical cystectomy patients.

Detailed Description

PRIMARY OBJECTIVES:

I. Explore and compare urinary outcomes in postoperative partial cystectomy patients and matched radical cystectomy patients through patient-filled questionnaires.

II. Explore and compare health related quality of life in postoperative partial cystectomy and matched radical cystectomy patients using patient-filled questionnaires.

III. Explore the relationship of patient-specific characteristics, ranging from demographic characteristics and clinicopathologic characteristics, on variation in HRQOL and urinary outcomes among the partial cystectomy and radical cystectomy cohorts.

OUTLINE: This is an observational study.

Patients complete questionnaires and have their medical records reviewed on study.

Study Timeline

• Study Start: 2025-01-15
• Status Verified: 2025-03
• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-18
• Last Update Submitted: 2025-03-18
• Study First Posted: 2025-03-24
• Last Update Posted: 2025-03-24
• Primary Completion: 2027-01-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Currently living partial cystectomy patients in Mayo Urology's cystectomy registry and patients undergoing radical or partial cystectomy
• Matched 2:1 living radical cystectomy to partial cystectomy patients
• Either urothelial or non-urothelial histology

Exclusion Criteria

• Partial cystectomy patients that underwent subsequent radical cystectomy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health-related quality of life - EORTC QLQ-C30	Up to 1 year	Assessed using the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30), which is designed to measure cancer patients' physical, psychological and social functions. It is a 30-item questionnaire related to symptoms and activities during the past week. Responses are recorded on a scale of 1-4 where 1=not at all, 2=a little, 3=quite a bit, and 4=very much. Scores among partial cystectomy patients will be compared to radical cystectomy patients.
Self-reported urinary outcomes	Up to 1 year	Assessed using the EORTC Quality of Life Questionnaire - Muscle Invasive Bladder Cancer (EORTC QLQ-BLM30), a 30-item questionnaire related to general symptoms experienced during the past week or during the past 4 weeks. Responses are recorded on a scale of 1-4 where 1=not at all, 2=a little, 3=quite a bit, and 4=very much. Scores among partial cystectomy patients will be compared to radical cystectomy patients.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States