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Completed

NCT Number: NCT05399004

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

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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Key information

Conditions

Bladder Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Sibley Memorial Hospital, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey Administration

Other

Complete surveys

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Sexual Function in Women After Radical Cystectomy

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jun 1, 2022
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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