Study on the Self-Administered Use of a Specialized Kit for the Management of Sexual Pain Associated With Endometriosis

Официальное название

Single-Center, Controlled, Randomized Study on the Self-Administered Use of a Specialized Kit for the Management of Sexual Pain Associated With Endometriosis

Обзор

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.

Подробное описание

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.

Female sexual dysfunction refers to the various reasons why a woman is unable to engage in sexual intercourse as she would like.

To address this need, Magalie Benoit, PhD in Gynecological Sciences and Psychotherapist, has developed an innovative methodology as well as three specific tools designed to support women with endometriosis in managing their sexual pain.

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 SAQ focuses on sexual pleasure, discomfort related to sexual intercourse, and the frequency of intercourse compared to a usual level. It is designed to accurately capture changes in sexual pain among women with endometriosis, where pain is often the predominant factor affecting their sexuality.

The SAQ measures various aspects related to sexual pain, such as:

* The intensity of pain experienced during sexual activity. * The emotional and psychological impact of sexual pain. * The effects on sexual satisfaction and overall sexual activity.

The SAQ consists of three sections: hormonal status, reasons for sexual inactivity, and sexual functioning. This last section calculates the SAQ score, which is the sum of 10 questions rated on a 4-point Likert scale (0=Not at all, 1=A little, 2=Moderately, 3=A lot). The total score ranges from 0 to 30; the higher the score, the better the sexual functioning.

The results obtained through this questionnaire 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 the responses obtained via 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 endovaginal 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 support 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 quality of sexual 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' ability to manage endometriosis-related sexual pain on their own.

Вмешательства

• Устройство Specialized kit
  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 (Guerrier-Benoit 2024) 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

Первичные конечные точки

• Sexual quality of life at 3 months between kit and no kit [Срок оценки: From enrollment to 3 months afterwards]

Вторичные конечные точки (6)

• Sexual quality of life after 3 months of specialized kit's use [Срок оценки: From reception of the kit to 3 months afterwards]
• Evaluating the use of the Endo-Sexo kit over a 3 months period [Срок оценки: From reception of the kit to 3 months afterwards]
• Pelvic pain modulation by specialized kit's use over 3 months [Срок оценки: From enrollement to 3 months afterwards]
• Long-term effect of the specialized kit on sexual quality of life [Срок оценки: From enrollement to 6 months afterwards]
• Need for additional medical care with and without the use of the specialized kit [Срок оценки: From enrollement to 3 months afterwards]
• Incidence of treatment-emergent adverse events [Срок оценки: From enrollment to 3 months afterwards]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Clinique de l'Estrée — Stains

Идентификаторы

NCT: NCT07683468 · KIT-ENDO-SEXO · 2025-A02206-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗