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

Mayo Clinic

Status: Completed

Conditions: Bladder Carcinoma

Treatments: Other: Survey Administration

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05399004

19-007376 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

34 participants in 1 patient group

Observational (survey)

Description:

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

Treatment:

Other: Survey Administration