Evaluating Sexual Function in Women Undergoing a Radical Cystectomy for Bladder Cancer
NCT ID: NCT05399004
Last Updated: 2024-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
34 participants
OBSERVATIONAL
2019-09-03
2024-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observational (survey)
Patients complete surveys over 15-20 minutes at baseline and at 3, 6, and 12 months.
Survey Administration
Complete surveys
Interventions
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Survey Administration
Complete surveys
Eligibility Criteria
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Inclusion Criteria
* A diagnosis of bladder cancer
* Planned to undergo a radical cystectomy
* Willing and able to complete survey questionnaires
Exclusion Criteria
* Non-English speaking
* Life expectancy less than 2 years
18 Years
FEMALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Stephen A. Boorjian, M.D.
Principal Investigator
Principal Investigators
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Stephen A Boorjian
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Louisiana State University
Lafayette, Louisiana, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Albany Medical Center
Albany, New York, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
M D Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
University of Washington Medical Center - Montlake
Seattle, Washington, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2021-13603
Identifier Type: REGISTRY
Identifier Source: secondary_id
19-007376
Identifier Type: -
Identifier Source: org_study_id
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