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Female Sexual Function After Cystectomy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04592848
Acronym
FSFAC
Enrollment
36
Registered
2020-10-19
Start date
2021-01-21
Completion date
2021-04-15
Last updated
2022-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sexual Activity

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.

Interventions

OTHERQuestionnaires

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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
FSFI Total Score in study populationat 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026