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临床试验/NCT03485261
NCT03485261Unknown不适用

Sexual Dysfunctions in Female Patients With Chronic Kidney Disease

Assiut University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
evaluation of female sexual dysfunctions in patients with chronic kidney disease.

研究概览

简要总结

A myriad of sexual problems affect men and women with chronic kidney disease (CKD), including decreased libido, erectile dysfunction, dysmenorrhea, and infertility. Menstrual abnormalities are common in CKD and many women are an-ovulatory.

Sexual dysfunction in CKD is multifactorial including hormonal alterations along with vascular, neurologic, psychogenic, and other factors, such as medications, contribute to the development of sexual dysfunction. Sexual dysfunction in females is mainly due to hormonal factors and manifests mainly as menstrual irregularities, amenorrhea, lack of vaginal lubrication, and failure to conceive.

详细描述

The study will be conducted on 100 female patients divided in to two equal group:

  1. Group A: The patient group include 50 female patients with chronic renal failure (eGFR <15ml/min/1.7m2 )
  2. Group B: The control group including 50 healthy females age matched with the patient group.

The Female Sexual Function Index (FSFI) will be used to assess sexual function. This index includes 19 questions related to 6 parameters: sexual desire, sexual arousal, lubrication, orgasm, sexual satisfaction and dyspareunia. A face-to-face inter-view with each participant in which the FSFI questions will be verbally asked and answered and compare between both groups in sexual activity and effect of chronic kidney disease on sexuality.

Duration of chronic kidney disease, duration of dialysis ,number of sessions of dialysis per week, medical treatment, haemoglobin,creatinine level will be fulfilled.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients with chronic kidney disease stage 5 with estimated glomerular filtration rate (eGFR) <15 ml/min/1.7m2 using the equation of MDRD (modification of diet in renal disease) on dialysis or not.
  • Age from 18 to 45 years old.
  • Sexually active during the last 6 months.

排除标准

  • Pregnant women.
  • Other medical diseases (diabetes mellitus, coronary artery disease, neurological disorders and other systematic diseases).
  • Taking medications affect sexuality function e.g. antidepressant drugs.

结局指标

主要结局

evaluation of female sexual dysfunctions in patients with chronic kidney disease.

时间窗: one year

questionnaire to female patients with chronic kidney disease

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

Esraa Ahmed Mohamed

eamohamed

Assiut University

研究点 (1)

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