Study on the Self-Administered Use of a Specialized Kit for the Management of Sexual Pain Associated With Endometriosis (KIT-ENDO-SEXO)
Single-Center, Controlled, Randomized Study on the Self-Administered Use of a Specialized Kit for the Management of Sexual Pain Associated With Endometriosis
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:
- 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.
- 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.
- 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.
調査の概要
詳細な説明
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:
- 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.
- 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.
- 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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Stains、フランス、93240
- 募集
- Clinique de l'Estrée
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コンタクト：
- Magalie Benoit, PhD
- 電話番号：+33 1 49 71 71 71
- メール：dr.magalie.benoit@gmail.com
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：No specialized kit
Patients will not receive the specialized kit and will continue their usual routine.
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実験的：With specialized kit
Patients will be given the specialized kit and will be free to use the different elements as they wish.
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The kit used in the study contains:
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Sexual quality of life at 3 months between kit and no kit
時間枠：From enrollment to 3 months afterwards
|
To assess whether using the Endo-Sexo kit improves the quality of sexual life for patients with endometriosis after 3 months of use by comparing patients who use the kit with those who do not. Sexual quality of life will be assessed using the Sexual Activity Questionnaire (SAQ). The difference in total scores between baseline and day 90 will be compared between the two groups. Nine of the ten SAQ items are rated on a 4 point Likert scale from 0 (not at allà to 3 (very much), therefore the total score can go from 0 to 27, with the last item being the frequency of sexual relations. A high score on the pleasure subscale represents high pleasure, and a low score on the discomfort subscale represents low discomfort. |
From enrollment to 3 months afterwards
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Sexual quality of life after 3 months of specialized kit's use
時間枠：From reception of the kit to 3 months afterwards
|
To assess whether use of the Endo-Sexo kit improves the sexual quality of life of patients with endometriosis by comparing data before and after 3 months of kit use across all study patients. Sexual quality of life will be assessed using the Sexual Activity Questionnaire (SAQ). The difference in the total score between the baseline level and the level at 3 months will be analyzed for all patients (Day 0 vs. Day 90 for Group 1 and Day 90 vs. Day 180 for Group 2). Nine of the ten SAQ items are rated on a 4 point Likert scale from 0 (not at allà to 3 (very much), therefore the total score can go from 0 to 27, with the last item being the frequency of sexual relations. A high score on the pleasure subscale represents high pleasure, and a low score on the discomfort subscale represents low discomfort. |
From reception of the kit to 3 months afterwards
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Evaluating the use of the Endo-Sexo kit over a 3 months period
時間枠：From reception of the kit to 3 months afterwards
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Frequency of use of the kit's various components during the first 3 months of use (based on information entered into the EndoDoute app)
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From reception of the kit to 3 months afterwards
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Pelvic pain modulation by specialized kit's use over 3 months
時間枠：From enrollement to 3 months afterwards
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To measure changes in pelvic pain levels (based on data from the EndoDoute app) after 3 months of use by comparing patients who used the kit with those who did not.The difference in the numerical score (from 1 to 5) for pelvic pain between baseline and day 90 (based on information entered into the EndoDoute app) will be studied.
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From enrollement to 3 months afterwards
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Long-term effect of the specialized kit on sexual quality of life
時間枠：From enrollement to 6 months afterwards
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Assess the long-term effect of the kit (in Group 1 patients only, comparing Day 0, Day 90, and Day 180) Sexual quality of life will be assessed using the Sexual Activity Questionnaire (SAQ). The difference in the total score between baseline and the 3-month mark will be compared to the difference in the total score between baseline and the 6-month mark for patients in Group 1. Nine of the ten SAQ items are rated on a 4 point Likert scale from 0 (not at allà to 3 (very much), therefore the total score can go from 0 to 27, with the last item being the frequency of sexual relations. A high score on the pleasure subscale represents high pleasure, and a low score on the discomfort subscale represents low discomfort. |
From enrollement to 6 months afterwards
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Need for additional medical care with and without the use of the specialized kit
時間枠：From enrollement to 3 months afterwards
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Assess the need for unplanned medical care after 3 months of use by comparing patients with and without the kit.
The number of unplanned medical appointments related to endometriosis during the first 3 months of the study willl be compared between patients in Group 1 and Group 2.
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From enrollement to 3 months afterwards
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Incidence of treatment-emergent adverse events
時間枠：From enrollment to 3 months afterwards
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Incidence of treatment-emergent adverse events between the group using the kit and the group not using the kit at 3 months.
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From enrollment to 3 months afterwards
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- KIT-ENDO-SEXO
- 2025-A02206-43 (その他の識別子：ID-RCB)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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