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

NCT05399004 | Completed

• 2 other identifiers: 19-007376NCI-2021-13603
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 14

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.

Conditions

Bladder Carcinoma

Outcome Measures

Primary Outcomes (5)

• Preoperative sexual function

  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

  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

  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

  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

  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 Outcomes (5)

• Labial discomfort

  From baseline to 3, 6, and 12 months

• Clitoral discomfort

  From baseline to 3, 6, and 12 months

• Orgasm ability

  From baseline to 3, 6, and 12 months

• Orgasm pleasure

  From baseline to 3, 6, and 12 months

• Change in sexual function scores

  From baseline to 12 months

Other Outcomes (8)

• Physical function

  From baseline to 3, 6, and 12 months

• Fatigue

  From baseline to 3, 6, and 12 months

• Pain interference

  From baseline to 3, 6, and 12 months

Study Arms (1)

Observational (survey)

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

Other: Survey Administration

Interventions

Survey Administration OTHER

Complete surveys

Observational (survey)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients undergoing radical cystectomy for bladder cancer between September 1, 2019 and December 31, 2022.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (14)

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

Louisiana State University

Lafayette, Louisiana, 70503, United States

Location

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Stephen A Boorjian

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 1, 2022
• Study Start: September 3, 2019
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: September 4, 2024

Record last verified: 2024-08

Locations

US (14)