Female Sexual Function After Cystectomy

Completed

• Conditions: Sexual Activity
• Interventions: Other: Questionnaires

• Registration Number: NCT04592848
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-16
• Study First Submitted QC: 2020-10-16
• Study First Posted: 2020-10-19
• Study Start: 2021-01-21
• Primary Completion: 2021-04-15
• Study Completion: 2021-04-15
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-28
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Population study	Questionnaires	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.

Primary Outcome Measures

Name	Time	Method
FSFI Total Score in study population	at least 6 months after the surgery (Cystectomy and/or urinary diversion)	The FSFI Score will be obtained from answers of the validated questionnaire "Female Sexual Function Index", a 19-item self-report measure of female sexual function.; It uses a 5-point Likert scale ranging from 1-5 for each item. It provides scores on overall levels of sexual function and its six components: Desire, Arousal, Lubrication, Orgasm, Satisfaction and Pain. The full scale score is between 2 and 36.; According to literature, total score of 26 or less indicates a risk of sexual dysfunction.; The version used in this study is the French one.

Trial Locations

Locations (1)

Hôpital Lyon Sud (Hospices Civils de Lyon); 🇫🇷 Pierre-Bénite, France