Bladder Cancer Clinical Trial

Evaluating Sexual Function in Women Undergoing a Radical Cystectomy for Bladder Cancer

Summary

This study evaluates the general physical, emotional, and sexual function in women undergoing a radical cystectomy for bladder cancer. A radical cystectomy is a surgical procedure that involves the removal of the bladder, uterus, ovaries, fallopian tubes, and part of the vagina. This may affect sexual function in women. This study seeks to understand how radical cystectomy alters sexual function and well-being, and what factors may affect this change.

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Full Description

PRIMARY OBJECTIVES:

I. To characterize pre-operative sexual function and interest in sexual activity of women undergoing radical cystectomy.

II. To identify patient understanding and expectations as they relate to sexual dysfunction after radical cystectomy.

III. To describe pre-operative importance in sexual function recovery after radical cystectomy.

IV. Quantify the changes in sexual function within the year following radical cystectomy in women.

V. Explore the effects of age, baseline sexual function, general quality of life, parity, menopausal status, hormone replacement therapy (topical versus [vs.] oral), general and cancer related quality of life, chemotherapy (neoadjuvant vs. adjuvant), treatment-related complications and performance status on sexual function outcomes.

VI. Explore the effects of robotic vs. open approach, extracorporeal vs. intracorporal approach, organ-sparing (ovaries, uterus, cervix, anterior vaginal wall), type of vaginal closure (vertical vs. horizontal), nerve sparing, urinary diversion type (ileal conduit vs. neobladder vs. continent cutaneous diversion) on sexual function outcomes.

VII. Quantify the changes in sexual activity interest within the year following radical cystectomy.

OUTLINE:

Patients complete surveys over 15-20 minutes at baseline and at 3, 6, and 12 months.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Adult women greater than 18 years of age
A diagnosis of bladder cancer
Planned to undergo a radical cystectomy
Willing and able to complete survey questionnaires

Exclusion Criteria:

Inability to provide informed consent
Non-English speaking
Life expectancy less than 2 years

Study is for people with:

Bladder Cancer

Estimated Enrollment:

180

Study ID:

NCT05399004

Recruitment Status:

Recruiting

Sponsor:

Mayo Clinic

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There are 13 Locations for this study

See Locations Near You

Sibley Memorial Hospital
Washington District of Columbia, 20016, United States More Info
Armine K. Smith
Contact
[email protected]
Armine K. Smith
Principal Investigator
Louisiana State University
Lafayette Louisiana, 70503, United States More Info
Mary E. Westerman
Contact
[email protected]
Mary E. Westerman
Principal Investigator
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore Maryland, 21287, United States More Info
Max Kates
Contact
[email protected]
Max Kates
Principal Investigator
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States More Info
Mark A. Preston
Contact
[email protected]
Mark A. Preston
Principal Investigator
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States More Info
Daniela Wittmann
Contact
800-865-1125
[email protected]
Daniela Wittmann
Principal Investigator
Mayo Clinic in Rochester
Rochester Minnesota, 55905, United States More Info
Stephen A. Boorjian
Contact
507-422-6679
[email protected]
Stephen A. Boorjian
Principal Investigator
Albany Medical Center
Albany New York, 12208, United States More Info
Svetlana Avulova
Contact
518-262-3341
[email protected]
Svetlana Avulova
Principal Investigator
UNC Lineberger Comprehensive Cancer Center
Chapel Hill North Carolina, 27599, United States More Info
Angela B. Smith
Contact
[email protected]
Angela B. Smith
Principal Investigator
University of Pennsylvania/Abramson Cancer Center
Philadelphia Pennsylvania, 19104, United States More Info
Trinity J. Bivalacqua
Contact
[email protected]
Trinity J. Bivalacqua
Principal Investigator
Vanderbilt University/Ingram Cancer Center
Nashville Tennessee, 37232, United States More Info
Amy N. Luckenbaugh
Contact
[email protected]
Amy N. Luckenbaugh
Principal Investigator
M D Anderson Cancer Center
Houston Texas, 77030, United States More Info
Neema Navai
Contact
[email protected]
Neema Navai
Principal Investigator
Huntsman Cancer Institute/University of Utah
Salt Lake City Utah, 84112, United States More Info
Brock O'Neil
Contact
[email protected]
Brock O'Neil
Principal Investigator
University of Washington Medical Center - Montlake
Seattle Washington, 98195, United States More Info
Sarah P. Psutka
Contact
[email protected]
Sarah P. Psutka
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Estimated Enrollment:

180

Study ID:

NCT05399004

Recruitment Status:

Recruiting

Sponsor:


Mayo Clinic

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