跳至主要内容
临床试验/NCT02894619
NCT02894619已完成不适用

Assessment of the Prevalence and Severity of Urinary and Ano-rectal Functional Disorders and Their Impact on Quality of Life and Sexuality on CF Adults of the North-West CF Network

Fondation Ildys6 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
180
试验地点
6
主要终点
Urinary Symptom Profile (USP) score

研究概览

简要总结

This observational study evaluates prevalence of functional perinea disorders (stress urinary incontinence, overactive bladder syndrome, dysuria, anal incontinence) on CF adults patients of the North-West CF Network. Its aims are to measure the severity of urinary and anorectal symptoms ; assess their impact on patients' quality of life, sexuality, care and social life and relationships ; identify the medical and demographic factors associated with the severity of urinary and anorectal disorders and their impact and determine the relationship between the severity of these disorders, various repercussions, and risk factors.

详细描述

Urine and/or anal leakage are more frequent and troublesome for CF patients: leaks occur during efforts or laugh like in other people, but also when coughing or sneezing, which are amplified during periods of exacerbation and with the degradation of the pulmonary condition. In addition, fear of leakage can disrupt medical care: discomfort during physiotherapy, pulmonary function test. Urinary and anorectal functional disorders are therefore not only a factor degrading the quality of life but also a risk factor for worsening bronchial obstruction, patients limiting their cough and / or their care to avoid episodes of leakage. Given the lack literature data, investigators wanted to explore these areas.

Validated and specific questionnaires will be self and anonymously administered to adult patients (n=175). The time requested to fill the forms is estimated to 1H. Questionnaires about sexual health are optional.

Prospects considered, depending on the results, are:

  • Extension to the adolescent population (14 and over);
  • National extension;
  • Systematic proposal of a screening and an appropriate management of pelvic floor functional disorders, depending on influent characteristics (age, gender ...): multidisciplinary working group to develop guidelines and specific tools for professional training and / or patient education;
  • Implementation of a comparative study of interventions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Men and women 18 years and over
  • Cystic fibrosis confirmed by sweat test or genetic
  • Followed in an adult or mixed CF Center of the French North-West CF Network
  • Not transplanted and not entered on the waiting list for transplantation
  • In a stable condition for at least 4 weeks
  • Able to understand and respect the protocol and its requirements
  • Who signed the consent prior to any other procedure protocol

排除标准

  • Major patients under guardianship / curatorship
  • Patients seen in emergency situation
  • Pregnant patients
  • Dialysis patients
  • Patients with urolithiasis
  • Patients with severe exacerbation at the time of inclusion
  • Patients on intravenous antibiotics within 4 weeks prior to inclusion
  • Patient with an urinary tract infection (evaluation by dipstick at the time of inclusion

结局指标

主要结局

Urinary Symptom Profile (USP) score

时间窗: at time of inclusion

Assesses lower urinary tract symptoms (stress urinary incontinence, overactive bladder syndrome and dysuria)

次要结局

  • International Index of Erectile Function (IIEF5) questionnaire(at time of inclusion)
  • Female Sexual Function Index (FSFI)(at time of inclusion)
  • Wexner Fecal Incontinence Scale(at time of inclusion)
  • Cystic Fibrosis Questionnaire-Revised (CFQ-R)(at time of inclusion)
  • SF-Qualiveen questionnaire(at time of inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

Loading locations...

相似试验