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

NCT06184516 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2025-09-15

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Tarik Benidir, MD · University of Florida

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-30
Primary Completion
2027-03-31
Completion
2028-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06184516 on ClinicalTrials.gov