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Female Sexual Function After Cystectomy

NCT04592848 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 36

Last updated 2022-04-29

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-21
Primary Completion
2021-04-15
Completion
2021-04-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04592848 on ClinicalTrials.gov