Clinical trial NCT05399004: Evaluating Sexual Function in Women Undergoing a Radical Cystectomy for Bladder Cancer
Official title: Sexual Function in Women After Radical Cystectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients undergoing radical cystectomy for bladder cancer between September 1, 2019 and December 31, 2022.

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.

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.

Eligibility 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

Primary outcomes:
measure: Preoperative sexual function
timeFrame: Baseline
measure: Interest in sexual activity
timeFrame: From baseline to 3, 6, and 12 months
measure: Lubrication
timeFrame: From baseline to 3, 6, and 12 months
measure: Vaginal discomfort
timeFrame: From baseline to 3, 6, and 12 months
measure: Satisfaction with sex life
timeFrame: From baseline to 3, 6, and 12 months
Secondary outcomes:
measure: Labial discomfort
timeFrame: From baseline to 3, 6, and 12 months
measure: Clitoral discomfort
timeFrame: From baseline to 3, 6, and 12 months
measure: Orgasm ability
timeFrame: From baseline to 3, 6, and 12 months
measure: Orgasm pleasure
timeFrame: From baseline to 3, 6, and 12 months
measure: Change in sexual function scores
timeFrame: From baseline to 12 months
Other outcomes:
measure: Physical function
timeFrame: From baseline to 3, 6, and 12 months
measure: Fatigue
timeFrame: From baseline to 3, 6, and 12 months
measure: Pain interference
timeFrame: From baseline to 3, 6, and 12 months
measure: Depressive symptoms
timeFrame: From baseline to 3, 6, and 12 months
measure: Anxiety
timeFrame: From baseline to 3, 6, and 12 months
measure: Ability to participate in social roles and activities
timeFrame: From baseline to 3, 6, and 12 months
measure: Sleep disturbances
timeFrame: From baseline to 3, 6, and 12 months
measure: Preoperative expectations/importance of sexual function recovery
timeFrame: Baseline
Locations:
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
city: Iowa City
country: United States
facility: University of Iowa/Holden Comprehensive Cancer Center
state: Iowa
city: Lafayette
country: United States
facility: Louisiana State University
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University/Sidney Kimmel Cancer Center
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Chapel Hill
country: United States
facility: UNC Lineberger Comprehensive Cancer Center
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania/Abramson Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University/Ingram Cancer Center
state: Tennessee
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute/University of Utah
state: Utah
city: Seattle
country: United States
facility: University of Washington Medical Center - Montlake
state: Washington
Study officials:
affiliation: Mayo Clinic in Rochester
name: Stephen A Boorjian
role: PRINCIPAL_INVESTIGATOR
References: