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

August 30, 2024 updated by: Stephen A. Boorjian, M.D., Mayo Clinic

Sexual Function in Women After Radical Cystectomy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Sibley Memorial Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Louisiana State University
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University/Sidney Kimmel Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Comprehensive Cancer Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Lineberger Comprehensive Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania/Abramson Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University/Ingram Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute/University of Utah
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center - Montlake

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
From baseline to 3, 6, and 12 months
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.
From baseline to 3, 6, and 12 months
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.
From baseline to 3, 6, and 12 months
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.
From baseline to 3, 6, and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to 3, 6, and 12 months
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.
From baseline to 3, 6, and 12 months
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.
From baseline to 3, 6, and 12 months
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.
From baseline to 3, 6, and 12 months
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.
From baseline to 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to 3, 6, and 12 months
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.
From baseline to 3, 6, and 12 months
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.
From baseline to 3, 6, and 12 months
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.
From baseline to 3, 6, and 12 months
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.
From baseline to 3, 6, and 12 months
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.
From baseline to 3, 6, and 12 months
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.
From baseline to 3, 6, and 12 months
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Stephen A Boorjian, Mayo Clinic in Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2019

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

May 26, 2022

First Submitted That Met QC Criteria

May 26, 2022

First Posted (Actual)

June 1, 2022

Study Record Updates

Last Update Posted (Actual)

September 4, 2024

Last Update Submitted That Met QC Criteria

August 30, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-007376 (Mayo Clinic in Rochester)
  • NCI-2021-13603 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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