Sexual Dysfunction in Hypertensive Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sample for the determination of antihypertensives or their metabolites., Questionnaire on sexual activity, Scale on hospital anxiety and depression, Morisky Questionaire.
- Who it may be relevant to
- Registry conditions: Hypertension. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Sexual Dysfunction in Hypertensive Women According to Drug Adherence: Multicenter Cross-sectional Study
Overview
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.
Interventions
- Biological Blood sample for the determination of antihypertensives or their metabolites.
15 ml of Blood sample for the determination of antihypertensives or their metabolites - Behavioral Questionnaire on sexual activity
Questionnaire on sexual activity in women - Behavioral Scale on hospital anxiety and depression
Scale on hospital anxiety and depression to detect anxious and depressive symptoms (14 questions) - Behavioral Morisky Questionaire
anti-hypertensive medication compliance questionnaire
Primary outcome measures
- Analyse of sexual dysfunction [Time frame: 25 months]
Secondary outcome measures (3)
- Percentage of patients with a good medication compliance by drug dosages and the Morisky questionnaire [Time frame: 25 months]
- Number of cases with sexual dysfunction in hypertensive women according to the antihypertensive pharmacological classes used [Time frame: 25 months]
- Number of cases with sexual dysfunction in hypertensive women according to the number of antihypertensive treatments; [Time frame: 25 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Patients with bariatric surgery,
- Patients under guardianship/trusteeship/protection of justice,
- Patients with diagnosed and treated psychosis or depression, - Pregnant or nursing women.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
France · 1 center
- LAZARO Delphine — Toulouse
Identifiers
NCT: NCT05156385 · RC31/19/0553