Evaluating a Decision Tool to Guide Gynecologic Organ-Sparing Surgery in Women Undergoing Radical Cystectomy for Bladder Cancer

What this Trial Is About

Women undergoing radical cystectomy for bladder cancer typically have their bladder and several reproductive organs removed. This standard procedure can lead to reduced quality of life, affecting sexual health, cognitive function, and mental health. Removal of the ovaries, especially in premenopausal women, may also increase risks such as cardiovascular problems, bone issues, and overall mortality. Researchers are studying a decision tool to identify women who can safely avoid removal of reproductive organs during surgery, aiming to maintain quality of life while providing effective cancer treatment. Participants will be assigned to one of two surgical approaches based on the decision tool reproductive organ sparing radical cystectomy for those classified as favorable, or standard radical cystectomy for those classified as unfavorable. The study uses pelvic MRI and cystoscopic evaluations to help classify patients. Both procedures involve removal of the bladder, but differ in whether reproductive organs like the uterus, ovaries, and fallopian tubes are also removed. During the study, participants will undergo pelvic imaging and cystoscopy before surgery to assess cancer involvement. Researchers will measure outcomes such as positive surgical margin rates within 120 days, sexual function and quality of life up to 15 months, and recurrence of cancer locally and at distant sites within 12 months. The study also assesses prediction accuracy for disease spread and pelvic organ involvement. Follow-up includes monitoring for cancer recurrence and quality of life effects for over a year after surgery.

Assessment of Decision Tool to Select Women for Gynecologic Sparing Radical Cystectomy