Assessment of Decision Tool to Select Women for Gynecologic Sparing Radical Cystectomy
University of Florida
Summary
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.
Eligibility
- Age range
- 18–99 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Female ≥ eighteen years of age * Histologically proven diagnosis of urothelial carcinoma of the bladder, including variant histology * Surgical candidate for radical cystectomy * Be able to undergo pelvic MRI. Minimum standards for MRI imaging will include the following: * MRI of the pelvis on 1.5T or higher strength magnet. * T2 weighted imaging in multiple planes. * T1 weighted imaging pre and post contrast administration (unless contrast is contraindicated by allergy or renal insufficiency) * Cystoscopic evaluation completed by urologist within 120 days prior t…
Interventions
- ProcedureReproductive organ sparing radical cystectomy
Participants on this arm will undergo a reproductive organ sparing radical cystectomy if they are classified as "favorable" based on the decision tool.
- ProcedureRadical cystectomy
Participants on this arm will undergo a radical cystectomy if they are classified as "unfavorable" based on the decision tool.
Location
- University of FloridaGainesville, Florida