Sexual Dysfunction in Hypertensive Women (DYSFHO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Biological: Blood sample for the determination of antihypertensives or their metabolites.; Behavioral: Questionnaire on sexual activity; Behavioral: Scale on hospital anxiety and depression; Behavioral: Morisky Questionaire

• Study Type: Interventional
• Enrollment (Estimated): 348
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Delphine LAZARO-VERGE; Phone Number: +33 5 61 32 30 68; Email: lazaro.d@chu-toulouse.fr

Study Locations

• France
  • CHU De Toulouse
    • Toulouse Cedex 9, CHU De Toulouse, France, 31059
      • Recruiting
      • LAZARO Delphine
      • Contact: Delphine LAZARO; Phone Number: +33 5 61 32 30 68; Email: lazaro.d@chu-toulouse.fr
      • Contact: Audrey TOMASIK; Phone Number: +33 561778597; Email: tomasik.a@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Hypertensive women

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analyse of sexual dysfunction	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	25 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with a good medication compliance by drug dosages and the Morisky questionnaire	Compare two methods of assessing drug compliance: drug dosages in the blood and the Morisky questionnaire; The score is rated on 8 points. A score of 8 is considered "good observant", a score between 6 and 7 "moderately observant patient" and a score strictly lower than 6 "poor observant".	25 months
Number of cases with sexual dysfunction in hypertensive women according to the antihypertensive pharmacological classes used	Estimate the prevalence of sexual dysfunction according to the antihypertensive pharmacological classes used (in the biologicale analysis)	25 months
Number of cases with sexual dysfunction in hypertensive women according to the number of antihypertensive treatments;	Estimate the prevalence of sexual dysfunction according to the number of antihypertensive treatments;	25 months

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Delphine LAZARO-VERGE, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2022
• Primary Completion (Estimated): June 7, 2024
• Study Completion (Estimated): June 7, 2024

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: November 30, 2021
• First Posted (Actual): December 14, 2021

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: sexual dysfunction; antihypertensive drugs; high blood pressure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Antihypertensive Agents
• Other Study ID Numbers: RC31/19/0553

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No