NCT06184516

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 147 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urothelial Carcinoma Bladder

Interventions

Type	Name	Description
PROCEDURE	Reproductive 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.
PROCEDURE	Radical cystectomy	Participants on this arm will undergo a radical cystectomy if they are classified as "unfavorable" based on the decision tool.

Timeline

• Start date: 2024-08-30
• Primary completion: 2027-03-01
• Completion: 2028-03-01
• First posted: 2023-12-28
• Last updated: 2025-09-15

Locations

1 site across 1 country: United States