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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05399004
Recruitment Status : Recruiting
First Posted : June 1, 2022
Last Update Posted : March 21, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Stephen A. Boorjian, M.D., Mayo Clinic

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Bladder Carcinoma Other: Survey Administration

Detailed 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sexual Function in Women After Radical Cystectomy
Actual Study Start Date : September 3, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
Observational (survey)
Patients complete surveys over 15-20 minutes at baseline and at 3, 6, and 12 months.
 Other: Survey Administration
Complete surveys


Outcome Measures
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Primary Outcome Measures :
  1. Preoperative sexual function [ Time Frame: Baseline ]
    Assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Brief Profile Sexual Function and Satisfaction version 2 (v2.0). Will utilize descriptive statistics to report preoperative sexual function. Frequencies and percentages will be reported for categorical variables and mean (standard deviation) or median (interquartile range) for continuous variables.

  2. Interest in sexual activity [ Time Frame: From baseline to 3, 6, and 12 months ]
    Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.

  3. Lubrication [ Time Frame: From baseline to 3, 6, and 12 months ]
    Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.

  4. Vaginal discomfort [ Time Frame: From baseline to 3, 6, and 12 months ]
    Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.

  5. Satisfaction with sex life [ Time Frame: From baseline to 3, 6, and 12 months ]
    Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.


Secondary Outcome Measures :
  1. Labial discomfort [ Time Frame: From baseline to 3, 6, and 12 months ]
    Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.

  2. Clitoral discomfort [ Time Frame: From baseline to 3, 6, and 12 months ]
    Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.

  3. Orgasm ability [ Time Frame: From baseline to 3, 6, and 12 months ]
    Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.

  4. Orgasm pleasure [ Time Frame: From baseline to 3, 6, and 12 months ]
    Will descriptively summarize the within-patient changes using the PROMIS Brief Profile Sexual Function and Satisfaction v2.0. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.

  5. Change in sexual function scores [ Time Frame: From baseline to 12 months ]
    Will use a linear mixed effects model of 12-month sexual function scores adjusting for baseline function to evaluate independent variables of interest related to the surgical procedure: age, robotic/open approach, pelvic organ sparing and diversion type. Variables of interest will be analyzed separately. In the analysis of robotic vs. open approach, the model will include terms for time (after surgery: 3, 6, and 12 months, using a discrete time formulation), approach (robotic=1, open=0), and approach by time interaction. Contrasts of the interaction and main effects will allow estimation of whether outcomes at 12 months differ by approach.


Other Outcome Measures:
  1. Physical function [ Time Frame: From baseline to 3, 6, and 12 months ]
    Assessed using the PROMIS - 29 Profile v2.1. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.

  2. Fatigue [ Time Frame: From baseline to 3, 6, and 12 months ]
    Assessed using the PROMIS - 29 Profile v2.1. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.

  3. Pain interference [ Time Frame: From baseline to 3, 6, and 12 months ]
    Assessed using the PROMIS - 29 Profile v2.1. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.

  4. Depressive symptoms [ Time Frame: From baseline to 3, 6, and 12 months ]
    Assessed using the PROMIS - 29 Profile v2.1. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.

  5. Anxiety [ Time Frame: From baseline to 3, 6, and 12 months ]
    Assessed using the PROMIS - 29 Profile v2.1. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.

  6. Ability to participate in social roles and activities [ Time Frame: From baseline to 3, 6, and 12 months ]
    Assessed using the PROMIS - 29 Profile v2.1. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.

  7. Sleep disturbances [ Time Frame: From baseline to 3, 6, and 12 months ]
    Assessed using the PROMIS - 29 Profile v2.1. Contrasts within the linear mixed effects model will compare changes in subdomain score between different time points.

  8. Preoperative expectations/importance of sexual function recovery [ Time Frame: Baseline ]
    Will use a linear mixed effects model of sexual function scores measured post-baseline through 12 months, adjusted for baseline sexual function score to evaluate if preoperative expectation/importance of sexual function recovery is associated with outcomes over time.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Female patients undergoing radical cystectomy for bladder cancer between September 1, 2019 and December 31, 2022.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05399004


Locations
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United States, District of Columbia
Sibley Memorial Hospital Recruiting
Washington, District of Columbia, United States, 20016
Contact: Armine K. Smith       asmit165@jhmi.edu   
Principal Investigator: Armine K. Smith         
United States, Iowa
University of Iowa/Holden Comprehensive Cancer Center Not yet recruiting
Iowa City, Iowa, United States, 52242
Contact: Vignesh T. Packiam    319-678-7104    Vignesh-packiam@uiowa.edu   
Principal Investigator: Vignesh T. Packiam         
United States, Louisiana
Louisiana State University Recruiting
Lafayette, Louisiana, United States, 70503
Contact: Mary E. Westerman       mweste@lsuhsc.edu   
Principal Investigator: Mary E. Westerman         
United States, Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Max Kates       Mkates@jhmi.edu   
Principal Investigator: Max Kates         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Mark A. Preston       mpreston@bwh.harvard.edu   
Principal Investigator: Mark A. Preston         
United States, Michigan
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Daniela Wittmann    800-865-1125    dwittman@umich.edu   
Principal Investigator: Daniela Wittmann         
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015    mayocliniccancerstudies@mayo.edu   
Principal Investigator: Stephen A. Boorjian, M.D.         
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Svetlana Avulova    518-262-3341    avulovs@amc.edu   
Principal Investigator: Svetlana Avulova         
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Angela B. Smith       angela_smith@med.unc.edu   
Principal Investigator: Angela B. Smith         
United States, Pennsylvania
University of Pennsylvania/Abramson Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Trinity J. Bivalacqua       Trinity.Bivalacqua@Pennmedicine.upenn.edu   
Principal Investigator: Trinity J. Bivalacqua         
United States, Tennessee
Vanderbilt University/Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Amy N. Luckenbaugh       amy.n.luckenbaugh@vumc.org   
Principal Investigator: Amy N. Luckenbaugh         
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Neema Navai       NNavai@mdanderson.org   
Principal Investigator: Neema Navai         
United States, Utah
Huntsman Cancer Institute/University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Brock O'Neil       brock.oneil@hci.utah.edu   
Principal Investigator: Brock O'Neil         
United States, Washington
University of Washington Medical Center - Montlake Recruiting
Seattle, Washington, United States, 98195
Contact: Sarah P. Psutka       spsutka@uw.edu   
Principal Investigator: Sarah P. Psutka         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Stephen A Boorjian Mayo Clinic in Rochester
More Information
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Responsible Party: Stephen A. Boorjian, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT05399004    
Other Study ID Numbers: 19-007376
NCI-2021-13603 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: June 1, 2022    Key Record Dates
Last Update Posted: March 21, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Urinary Bladder Diseases
Urologic Diseases
Male Urogenital Diseases