Female Sexual Function After Cystectomy

Sexual Activity Clinical Trial

— FSFAC  

Official title:

Female Sexual Function and Sexual Quality of Life After Cystectomy or Urinary Diversion in Patients With Non-malignant Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04592848
• Other study ID #: 69HCL20_0873
• Status: Completed
• Start date: January 21, 2021
• Est. completion date: April 15, 2021

Study information

• Verified date: April 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 15, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Sexual Activity

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	Hôpital Lyon Sud (Hospices Civils de Lyon)	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FSFI Total Score in study population	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.	at least 6 months after the surgery (Cystectomy and/or urinary diversion)