Hôpital Lyon Sud (Hospices Civils de Lyon)
Pierre-Bénite, 69003, France
NCT Number: NCT04592848
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.
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Notify Me18 year–75 year
Female
Observational
Pierre-Bénite, 69003, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Four Questionnaires in French will be sent to participants :
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:
Time frame: 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.
Hospices Civils de Lyon
Other
Female Sexual Function and Sexual Quality of Life After Cystectomy or Urinary Diversion in Patients With Non-malignant Disease
Acronym: FSFAC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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