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.
Female ≥ eighteen years of age
Histologically proven diagnosis of urothelial carcinoma of the bladder, including variant histology
Surgical candidate for radical cystectomy
MRI of the pelvis on 1.5T or higher strength magnet.
Patients with regional or distant metastatic disease
Non-urothelial bladder cancer.
Not a surgical candidate for radical cystectomy
Unable to have MRI of pelvis that meets the minimum standards in the inclusion criteria above.
Parallel
Reproductive organ sparing radical cystectomy
Procedure/SurgeryParticipants on this arm will undergo a reproductive organ sparing radical cystectomy if they are classified as "favorable" based on the decision tool.
Radical cystectomy
Procedure/SurgeryParticipants on this arm will undergo a radical cystectomy if they are classified as "unfavorable" based on the decision tool.
Positive 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
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.
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").
Local recurrence
Determine the local recurrence rate.
Distant recurrence
Determine the distant recurrence rate.
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