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Clinical Trials/NCT02174185
NCT02174185
Unknown
Not Applicable

A Prospective and Comparative Study of Health-related Quality of Life (HRQoL) in Patients With Conduit Diversion or Orthotopic Neobladder

Huazhong University of Science and Technology1 site in 1 country300 target enrollmentAugust 2014
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ConditionsBladder Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bladder Cancer
Sponsor
Huazhong University of Science and Technology
Enrollment
300
Locations
1
Primary Endpoint
Change from baseline in HRQoL of bladder cancer patients with different types of urinary diversions
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The aim of this study is to compare the health-related quality of life (HRQoL) between patients underwent conduit diversion and orthotopic neobladder after radical cystectomy. The investigators plan to use validated HRQoL questionnaires to learn about how the different urinary diversion operations affect the HRQoL of people living with bladder cancer. The findings from this study may help doctors and patients choosing the proper operation type.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
August 2018
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zhang Xiaoping

Director of Department of Urology, Wuhan Union Hospital, HUST

Huazhong University of Science and Technology

Eligibility Criteria

Inclusion Criteria

  • •Clinical diagnosis of muscle invasive bladder cancer
  • •Must be scheduled for radical cystectomy and subsequent conduit diversion or orthotopic neobladder
  • •Must be able to provide informed consent
  • •Must be 18 years of age or older
  • •May have had received intravesical neoadjuvant, adjuvant chemotherapy or immunotherapy

Exclusion Criteria

  • •Follow-up data not obtained at Wuhan Union Hospital

Outcomes

Primary Outcomes

Change from baseline in HRQoL of bladder cancer patients with different types of urinary diversions

Time Frame: Preoperative baseline and 3, 6, 12, 18 months postoperatively

Secondary Outcomes

  • Score differences between the two groups of patients in the relevant domains from three various validated tools of HRQoL(Preoperative baseline and 3, 6, 12, 18 months postoperatively)
  • Score changes of each patient group during the follow-up(Preoperative baseline and 3, 6, 12, 18 months postoperatively)
  • Objective examination outcomes(Preoperative baseline and 3, 6, 12, 18 months postoperatively)

Study Sites (1)

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