Sexual Dysfunction in Hypertensive Women

Официальное название

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

Обзор

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.

Вмешательства

• Биопрепарат Blood sample for the determination of antihypertensives or their metabolites.
  15 ml of Blood sample for the determination of antihypertensives or their metabolites
• Поведенческое Questionnaire on sexual activity
  Questionnaire on sexual activity in women
• Поведенческое Scale on hospital anxiety and depression
  Scale on hospital anxiety and depression to detect anxious and depressive symptoms (14 questions)
• Поведенческое Morisky Questionaire
  anti-hypertensive medication compliance questionnaire

Первичные конечные точки

• Analyse of sexual dysfunction [Срок оценки: 25 months]

Вторичные конечные точки (3)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Франция · 1 центр

• LAZARO Delphine — Toulouse

Идентификаторы

NCT: NCT05156385 · RC31/19/0553

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗