Study on the Self-Administered Use of a Specialized Kit for the Management of Sexual Pain Associated With Endometriosis
Recruiting · NCT07683468 · Interventional (participants receive a specific treatment) · Lead sponsor: Elsan
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Endometriosis is a complex gynecological condition that affects approximately 10% of women of reproductive age, according to 2023 data from the World Health Organization. Endometriosis is often associated with debilitating pain, particularly during sexual intercourse (dyspareunia). This pain profoundly affects these patients' sexual health and, consequently, their quality of life, yet it remains frequently misunderstood and inadequately managed, partly due to a lack of information and appropriate tools. One of the key aspects of this study is the use of the Sexual Activity Questionnaire (SAQ), an internationally recognized assessment tool for measuring the impact of treatment on sexual functioning. The SAQ collects precise data on sexual activity (primarily frequency), the level of sexual pleasure, and the perceived pain potential experienced by patients during sexual activity, assessing not only the intensity of pain but also its influence on the emotional and relational aspects of intimate life. The SAQ has been validated to assess the impact of surgical treatments for endometriosis on sexual functioning. The results obtained through this questionnaire in routine clinical practice formed the basis for the tools developed by Dr. Magalie Benoit, providing an in-depth understanding of the different types of pain experienced by patients. The kit used in the study contains: 1. The Endo-Sexo Guide: A 258-page book that compiles and analyzes possible responses to the SAQ. It explains in detail the mechanisms of sexual pain and offers personalized solutions to alleviate it. 2. The Endo Doute app: It allows women to keep a journal tracking pain (frequency and intensity), the frequency of sexual intercourse, and the tools used to relieve pain (including those provided in the kit). It also allows users to export their data to share with the healthcare professionals involved. 3. A set of practical tools for managing sexual pain on a daily basis, including an endo-vaginal TENS device to treat dyspareunia, penis rings to limit deep penetration, hyaluronic acid suppositories, CBD (cannabinoid) lubricant gel, sublingual CBD oil to reduce stress, as well as two dietary supplements-one containing palmitoylethanolamide (PEA) to combat inflammation and the other made from herbs to aid menstrual comfort. These tools will be used independently by patients, offering them personalized solutions to better understand and manage their pain on their own. Each patient will be able to choose whether or not to use the various components of the kit and how often to use them. Empowering patients to manage their own pain should improve their sexual quality of life and reduce the need for occasional or unscheduled medical care. This project represents the first initiative aimed at evaluating the impact of these tools on patients' autonomy in managing sexual pain related to endometriosis.
Who can take part
Inclusion criteria
- Women aged 18 to 45
- Sexually active within the past 3 months
- Confirmed diagnosis of endometriosis
- Pain during sexual intercourse, as reported by the patient
- Patients enrolled in or covered by the French social security system.
- Patients who have been informed and have provided their free, informed, and written consent (no later than the day of enrollment and prior to any examination required for the study).
Exclusion criteria
- Patients participating in another interventional clinical trial for endometriosis.
- Pregnant, breastfeeding, or laboring women
- Patients who do not speak French or are unable to provide informed consent for the study
- Patients with an allergy to any component of the study kit
- Individuals who do not have a touchscreen mobile phone compatible with the Endo Doute app.
- Participants whose physical and/or psychological health is severely impaired, which, in the investigator's opinion, may affect the participant's compliance with the study.
- Participants currently in the exclusion period of another ongoing study at the time of enrollment.
- Protected participants: adults under guardianship, conservatorship, or other legal protection; or individuals deprived of their liberty by judicial or administrative order.
Where it is running
1 location listed.
- Clinique de l'Estrée - Stains, France