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临床试验/NCT04415710
NCT04415710已完成不适用

Investigation of the Relationship Between the Pelvic Floor and Sexual Dysfunction in Women with Sjogren's Syndrome

Akdeniz University1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2019年2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
94
试验地点
1
主要终点
Pelvic Floor Distress Inventory PFDI-20

研究概览

简要总结

Sjogren's syndrome (SS) is a chronic, systemic, autoimmune disease characterized by lymphocytic infiltration of all exocrine glands, especially tear and salivary glands, and is more common in women.

详细描述

Sexual functions are affected by symptoms such as pain, fatigue, stiffness, and hormonal imbalance in rheumatological disorders. Vaginal dryness and dyspepsia negatively affect participation in sexual activity. The aim of the study is to examine the pelvic floor problems of women with SS with a self-report, to compare them with healthy individuals, and finally to examine the relationship between pelvic floor problems and sexual dysfunction.

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 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • being between the ages of 18-65
  • being a woman,
  • having sex partner,
  • no smoking, no alcohol

排除标准

  • physical, psychological, cognitive impairment,
  • having a non-Sjögren additional disease,
  • malignancy,
  • pregnancy,
  • no urogenital disease,
  • sarcoidosis,
  • anticholinergic drug use,
  • had a gynecological or urological operation other than cesarean

结局指标

主要结局

Pelvic Floor Distress Inventory PFDI-20

时间窗: 1 week

Pelvic Floor Distress Inventory has a total of 20 questions and 3 scales (Urinary Distress Inventory, Pelvic Organ Prolapse Distress Inventory, and Colorectal-Anal Distress Inventory). Each short-form scale demonstrates significant correlation with their long-form scales

Pelvic Floor Impact Questionnaire PFIQ

时间窗: 1 week

Pelvic Floor Impact Questionnaire (PFIQ): The questionnaire has 7 questions and each question has 3 separate responses. The response to each item of satisfaction, impact and worry was rated from 3 (quite a bit) to 0 (not at all) for the PFIQ-7. The mean value for all the answered items within the corresponding scale (possible value 0-3) was estimated, then multiplied by (100/3) to obtain the scale score, range 0-100.

Female Sexual Dysfunction Index FSFI

时间窗: 1 week

The FSFI is a brief questionnaire measure of sexual functioning in women. It was developed for the specific purpose of assessing domains of sexual functioning (e.g. sexual arousal, orgasm, satisfaction, pain) in clinical trials.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alime Buyuk

PhD Student

Akdeniz University

研究点 (1)

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