跳至主要内容
临床试验/NCT05156385
NCT05156385招募中不适用

Sexual Dysfunction in Hypertensive Women According to Drug Adherence: Multicenter Cross-sectional Study

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 348 人开始时间: 2022年6月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
348
试验地点
2
主要终点
Analyse of sexual dysfunction

研究概览

简要总结

Several studies describe the existence of an association between sexual dysfunction and high blood pressure (hypertension), most often characterized by a decrease in the number of orgasms and the existence of dyspareunia.

Hypertension is a contributing factor, and nonadherence to medication could amplify it.

There are several ways to assess adherence to treatment: the use of declarative questionnaires, a method not without criticism because it is subject to the subjectivity of the declaration by the patient; and drug dosages, a standard technique, although insufficiently disseminated due to the high cost and greater weight of the survey protocols. Drug non-compliance is multifactorial. In addition, it has been shown that having undesirable drug effects and / or being afraid of developing them is one of the major causes of non-compliance with antihypertensive treatments.

The investigators hypothesize that DS is significantly more common among hypertensive women treated with non-observers compared to hypertensive women treated with observers.

The main objective is to compare the prevalence of sexual dysfunction between a group of hypertensive women treated as observers and a group of hypertensive women treated as non-observers.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • Women over 18,
  • Hospitalized or received in consultation for the management of hypertension treated in one of the hypertension and therapeutic, nephrology or cardiology departments participating in the study, with confirmed hypertension, treated with the following dosable antihypertensive agent(s): diltiazem, verapamil, acebutolol, atenolol, nébivolol, bisoprolol, metoprolol, propranolol, amiloride, furosemide, hydrochlorothiazide, indapamide, spironolactone, spironolactone, Lorsartan, Irbesartan, Ramipril, Perindopril, Amlodipine,
  • Having signed the informed consent form.
  • Beneficiary or affiliated to a French Social insurance

排除标准

  • Patients with bariatric surgery,
  • Patients under guardianship/trusteeship/protection of justice,
  • Patients with diagnosed and treated psychosis or depression, - Pregnant or nursing women.

研究组 & 干预措施

Hypertensive women

Experimental

干预措施: Blood sample for the determination of antihypertensives or their metabolites. (Biological)

Hypertensive women

Experimental

干预措施: Questionnaire on sexual activity (Behavioral)

Hypertensive women

Experimental

干预措施: Scale on hospital anxiety and depression (Behavioral)

Hypertensive women

Experimental

干预措施: Morisky Questionaire (Behavioral)

结局指标

主要结局

Analyse of sexual dysfunction

时间窗: 25 months

Prevalence of sexual dysfunction defined by a score less than 26 on the Female Sexual Function Index scale : score less than 26 mean a sexual dysfunction

次要结局

  • Percentage of patients with a good medication compliance by drug dosages and the Morisky questionnaire(25 months)
  • Number of cases with sexual dysfunction in hypertensive women according to the number of antihypertensive treatments;(25 months)
  • Number of cases with sexual dysfunction in hypertensive women according to the antihypertensive pharmacological classes used(25 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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