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临床试验/NCT02899572
NCT02899572Unknown不适用

Impact of a Sexology Consultation on Diabetes Disease Control of Type 2 Male Diabetics With Erectile Dysfunction: a Monocentric Randomised Comparative Study

Centre Hospitalier Universitaire de la Réunion2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2015年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
64
试验地点
2
主要终点
Measurement of HbA1c according to the randomisation group

研究概览

简要总结

Erection disorders constitute the first sign of vascular injury in type 2 diabetes patients. The important frequency of these disorders and their consequences in term of quality of life have a strong contrast with the actual interest showed for them by the medical community.

Natural evolution of the disease and its management make that these disorders often occur little time after a therapeutic change. As a consequence, patients often accuse their medication to be responsible for the appearance of these disorders. This confusion, associated to false believes that may have the patients on their disease or their treatment, often leads to treatment discontinuation which has a deleterious effect on the disease evolution.

Educational therapy programs showed a positive impact on therapeutic adherence. Increasing patients' knowledge on their disease and treatments increases their therapeutic adherence and makes it easier to balance diabetes and therefore limits complications appearance.

Educational therapy programs concern today the disease, its process, its evolution, its treatments, their efficacy, their adverse effects but erection disorders are not specifically addressed.

This study aims to evaluate the impact of a sexology consultation on diabetes balance measured via HbA1c rate. This consultation aims at precising this particular symptom of erection disorders, without any medicine prescription. The aim is to explain to patients the different links between their symptoms, diabetes, medicines and themselves.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • type 2 diabetic male medically treated
  • aged from 18 to 65 years old included
  • having issue obtaining or maintaining an erection allowing a satisfying sexual intercourse
  • hospitalised or followed in consultation in one of the 2 participating sites

排除标准

  • treated by a medicine which could be responsible for the erectile disorders (beta-blockers, central anti-hypertensive drugs, antialdosterones)
  • presenting another disease which could be responsible for the erectile disorders (neurological, hormonal, vascular, psychiatric diseases)
  • treated by an insulin pump

结局指标

主要结局

Measurement of HbA1c according to the randomisation group

时间窗: 3 months after inclusion

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Universitaire de la Réunion
申办方类型
Other
责任方
Sponsor

研究点 (2)

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