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OpenTrials
Completed

NCT Number: NCT04592848

Female Sexual Function After Cystectomy

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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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Hôpital Lyon Sud (Hospices Civils de Lyon)

Pierre-Bénite, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

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

Primary outcomes

  1. FSFI Total Score in study population

    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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: FSFAC

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 19, 2020
Registry last updated
Apr 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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