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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sexual Function in Women After Radical Cystectomy

Conditions
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Bladder Carcinoma

Intervention / Treatment
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* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (survey)<br>Patients complete surveys over 15-20 minutes at baseline and at 3, 6, and 12 months. | Other: Survey Administration<br>* Complete surveys<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Labial 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 | 
| Clitoral 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 | 
| Orgasm ability | 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 | 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 | 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 |