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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05399004
Study type Observational
Source Mayo Clinic
Contact
Status Active, not recruiting
Phase
Start date September 3, 2019
Completion date September 2024

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