Clinical trial NCT04592848: Female Sexual Function After Cystectomy
Official title: Female Sexual Function and Sexual Quality of Life After Cystectomy or Urinary Diversion in Patients With Non-malignant Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sexual Activity
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
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

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.


Eligibility 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

Primary outcomes:
measure: FSFI Total Score in study population
timeFrame: at least 6 months after the surgery (Cystectomy and/or urinary diversion)
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Hôpital Lyon Sud (Hospices Civils de Lyon)
Study officials:
References: