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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to 99 Years
• SexFemale
• Healthy volunteersNo

You may be able to join if

• 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 to surgery (ROS-RC or RC)
• Staging imaging within 90 days prior to surgery (ROS-RC or RC). If receiving neoadjuvant therapy prior to surgery (ROS-RC or RC), repeat staging imaging must be completed after the neoadjuvant therapy is completed, or no longer tolerated by the patient.
• Staging imaging must include MRI of the pelvis within 90 days of surgery (ROS-RC or RC)
• Written informed consent obtained from the subject and the ability for the subject to comply with all the study-related procedures.
• Presence of at least one or more ancillary organs. Ancillary organs defined as anterior vagina, uterus, fallopian tubes (only 1 tube present will be considered at physician discretion), and ovaries.
• ECOG Performance Status of 0-2

You cannot join if

• 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.
• Subjects of childbearing potential (SOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy during study intervention and for at least 12 weeks after the study intervention.
• Patients with other known active malignancies which may confound the recurrence rates
• Patients with known germline mutations in DNA damage repair genes (BRCA1/BRCA 2)
• Prisoners or subjects who are involuntarily incarcerated.
• Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
• Subjects demonstrating an inability to comply with the study and/or follow-up procedures.
• Subjects who are confirmed to be pregnant or breastfeeding.
• History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for complications, in the opinion of the treating physician.
• Administration of a vaccine containing live virus within 30 days prior to the study intervention. Note: Most flu vaccines are killed viruses, with the exception of the intra-nasal vainer (Flu-Mist) which is an attenuated live virus and therefore prohibited for 30 days prior to first dose. Non-live versions of the COVID vaccine are allowed.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

• Reproductive organ sparing radical cystectomy (Procedure): Participants 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): Participants on this arm will undergo a radical cystectomy if they are classified as "unfavorable" based on the decision tool.

Non Randomized · Parallel · masking: None

Main goals

• Positive margin rate (120 days)

Other goals

• Sexual function
• Quality of life
• Local recurrence
• Distant recurrence
• Incidence rate of adjacent pelvic organ involvement
• Prediction of extravesicular disease
• Prediction of adjacent pelvic organ involvement

Planned enrollment: 127 (estimated).

• University of Florida, Gainesville, Florida

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT06184516

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 8, 2026. Public record; not medical advice.