Female Sexual Function After Cystectomy

NCT ID: NCT04592848

Last Updated: 2022-04-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-21
• Study Completion Date: 2021-04-15

Brief Summary

Cystectomy with bladder replacement, with or without urinary diversion, is the preferred treatment option for benign pathologies responsible for neurogenic bladder or sphincter dysfunction after failure of conservative treatments.

This surgery has both the objective of preventing urological complications and improving quality of life.

We know that women are especially affected by these conditions, as demonstrated by the high prevalence of demyelinating diseases such as multiple sclerosis in this population. Patients are often young and sexually active before the surgery.

Despite the existence of validated evaluation tools since the early nineties, there is poor data exploring effects of invasive procedures such as cystectomy on sexual activity and quality of sexual life in female patients.

Indeed, existing literature largely focuses on sexual function in male population after cystectomy for urothelial cancer.

Data on sexual function after stoma formation in women with colorectal cancer show a significant change after the surgery, partly due to body image issues. We can easily suppose that there's also an important impact of cystectomy that may affect sexual quality of life.

Thus, the objective of the study is to assess sexual function and determine factors that may influence sexual quality of life in female patients following cystectomy or urinary diversion.

Conditions

Sexual Activity

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Study Groups

Population study

Female patients who undergone a cystectomy and/or urinary diversion for a non-malignant disease at "Lyon Sud" Hospital between January 2007 and December 2019.

Questionnaires

Intervention Type: OTHER

Four Questionnaires in French will be sent to participants :

• 1 questionnaire about sexual and urinary symptoms before and after the surgery ;
• 1 validated questionnaire "Female Sexual Function Index" to assess sexual function over the past 4 weeks ;
• 1 validated questionnaire "Body Image Scale" to assess body image during the past week ;
• 1 validated questionnaire "Stoma Quality of Life", only for patients with incontinent urostomy.

If the questionnaires are not returned 15 days after sending, a follow-up phone call will be made by one of the investigators.

The data collection will include both the answers to the questionnaires and the patients' computerized medical data:

• Pathology responsible for the urological disorders and date of onset of the disorders
• Date and Type of surgery performed
• Patient's age at the time of surgery
• Post-operative complications within one month of surgery

Interventions

Questionnaires

Four Questionnaires in French will be sent to participants :

• 1 questionnaire about sexual and urinary symptoms before and after the surgery ;
• 1 validated questionnaire "Female Sexual Function Index" to assess sexual function over the past 4 weeks ;
• 1 validated questionnaire "Body Image Scale" to assess body image during the past week ;
• 1 validated questionnaire "Stoma Quality of Life", only for patients with incontinent urostomy.

If the questionnaires are not returned 15 days after sending, a follow-up phone call will be made by one of the investigators.

The data collection will include both the answers to the questionnaires and the patients' computerized medical data:

• Pathology responsible for the urological disorders and date of onset of the disorders
• Date and Type of surgery performed
• Patient's age at the time of surgery
• Post-operative complications within one month of surgery

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Female patients aged from 18 to 75 years
• With Partial or total cystectomy and/or urinary diversion and/or urinary ostomy repair operations between 01/01/2007 and 15/12/2019 at the "Lyon Sud" Hospital.
• Surgery was performed for urological disorders caused by a non-malignant disease
• Patients currently more than 6 months away from the last urological cystectomy/ urinary diversion/ urinary stoma repair surgery

Exclusion Criteria

• Patients deceased
• Patients who undergone a partial cystectomy without urinary diversion for endometriosis with bladder involvement
• Patients unable to complete the questionnaires

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Lyon Sud (Hospices Civils de Lyon)

Pierre-Bénite, , France

Countries

France

Other Identifiers

69HCL20_0873

Identifier Type: -

Identifier Source: org_study_id