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临床试验/NCT04592848
NCT04592848已完成不适用

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

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年1月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
FSFI Total Score in study population

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Patients deceased
  • Patients who undergone a partial cystectomy without urinary diversion for endometriosis with bladder involvement
  • Patients unable to complete the questionnaires

结局指标

主要结局

FSFI Total Score in study population

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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