Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2025-12-26 @ 5:04 PM
Study NCT ID:
NCT05399004
Status:
COMPLETED
Last Update Posted:
2024-09-04
First Post:
2022-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Sexual Function in Women Undergoing a Radical Cystectomy for Bladder Cancer
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Sexual Function in Women After Radical Cystectomy
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2021-13603 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |