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Female Sexual Function After Cystectomy (FSFAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04592848
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : July 14, 2021
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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.


Condition or disease Intervention/treatment
Sexual Activity Other: Questionnaires

Study Design
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Study Type : Observational
Estimated Enrollment : 151 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Female Sexual Function and Sexual Quality of Life After Cystectomy or Urinary Diversion in Patients With Non-malignant Disease
Actual Study Start Date : January 21, 2021
Estimated Primary Completion Date : August 21, 2021
Estimated Study Completion Date : August 21, 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
Population study
Female patients who undergone a cystectomy and/or urinary diversion for a non-malignant disease at "Lyon Sud" Hospital between January 2007 and December 2019.
 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


Outcome Measures
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Primary Outcome Measures :
  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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population consists in alive female patients aged 18-75 years, who undergone a 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 and able to complete the questionnaires.

All patients suffer from urological disorders caused by a non-malignant pathology, and have had surgery after failure of conservative therapies.

Among the patients identified from the computerized medical records, 55 suffer from Multiple sclerosis, 29 patients from Spinal Cord Injury, 21 suffer from Suprapontine and pontine lesion or disease, 19 suffer from non-traumatic lesion or disease between caudal brainstem and sacral spinal cord,18 suffer from lesions of the peripheral nervous system, 8 suffer from interstitial cystitis or idiopathic disorders and 1 suffers from a neurodegenerative disease of unknown etiology

Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04592848


Contacts
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Contact: Nicolas Morel-Journel, MD +33472678837 nicolas.morel-journel@chu-lyon.fr
Contact: Margaux Louar +33620115267 margaux.louar@chu-lyon.fr

Locations
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France
Hôpital Lyon Sud (Hospices Civils de Lyon) Recruiting
Pierre-Bénite, France, 69003
Contact: Nicolas Morel-Journel, MD    +33472678837      
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04592848    
Other Study ID Numbers: 69HCL20_0873
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: July 14, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No