Currently, the standard of care for female patients undergoing radical cystectomy includes the removal of the bladder, pelvic lymph nodes, anterior vagina, uterus, fallopian tubes and ovaries. Removal of female ancillary organs, both in pre and post-menopausal stages is associated with reduction in various quality of life metrics, including sexual health, cognitive decline and depression. Furthermore, removal of ovaries has been associated with increased cardiovascular events, metabolic acidosis, osteoporosis and bone fractures. In premenopausal women, the removal of the ovaries is associated with increased all-cause mortality. From an oncologic standpoint, multi institutional retrospective reviews have demonstrated certain pre-operative radiographic and cystoscopic risk factors that are associated with bladder cancer involvement of female reproductive organs. The absence of these unfavorable risk factors may provide an opportunity to spare women from undergoing unnecessary reproductive organ removal during RC. In doing so, this may eliminate the associated sequelae of removing these additional organs while also providing acceptable oncologic care. The investigators thus propose a decision tool to stratify women undergoing radical cystectomy as favorable and unfavorable for reproductive organ sparing radical cystectomy. This decision tool classification will be used to decide which patients will undergo reproductive organ sparing radical cystectomy versus radical cystectomy in this study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
147
Participants on this arm will undergo a reproductive organ sparing radical cystectomy if they are classified as "favorable" based on the decision tool.
Participants on this arm will undergo a radical cystectomy if they are classified as "unfavorable" based on the decision tool.
University of Florida
Gainesville, Florida, United States
RECRUITINGPositive margin rate
Determine the positive margin status rate (based on the surgical pathology report) for the favorable cohort who successfully undergo reproductive organ sparing radical cystectomy
Time frame: 120 days
Sexual function
Evaluate sexual function as measured by the Female Sexual Function Index (FSFI). The FSFI consists of 19 questions measuring female sexual function across six domains, including desire (2 items), arousal (4 items), lubrication (4 items), orgasm (3 items), satisfaction (3 items), and pain (3 items). Each response is assigned a score of either 0 to 5 or 1 to 5, with a higher score meaning a greater level of sexual functioning. The scores are summed to produce a composite score ranging from 4 to 36, with a higher score meaning better sexual functioning.
Time frame: 15 months
Quality of life
Evaluate quality of life as measured by the FACT-G questionnaire. The FACT-G measures various aspects of physical, social, emotional, and functional well-being over the past 7 days on a scale of 0-4 (with 0 meaning "Not at all" and 4 meaning "Very much").
Time frame: 15 months
Local recurrence
Determine the local recurrence rate.
Time frame: 12 months
Distant recurrence
Determine the distant recurrence rate.
Time frame: 12 months
Incidence rate of adjacent pelvic organ involvement
Determine the incidence of adjacent pelvic organ involvement in women undergoing radical cystectomy deemed "unfavorable" based on the decision tool.
Time frame: 12 months
Prediction of extravesicular disease
Evaluate the ability of staging MRI of the pelvis to predict extravesicular disease.
Time frame: 15 months
Prediction of adjacent pelvic organ involvement
Evaluate the ability of staging MRI of the pelvis to predict adjacent pelvic organ involvement
Time frame: 15 months
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