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NCT Number: NCT06891209

Exploration of HRQOL and Urinary Outcomes Following Partial Cystectomy

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

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Key information

Conditions

Bladder Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Primary outcomes

  1. Health-related quality of life - EORTC QLQ-C30

    Time frame: 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.

  2. Self-reported urinary outcomes

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 24, 2025
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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