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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A02206-43 | Other Identifier | ID-RCB |
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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:
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.
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 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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No specialized kit | No Intervention | Patients will not receive the specialized kit and will continue their usual routine. | |
| With specialized kit | Experimental | Patients will be given the specialized kit and will be free to use the different elements as they wish. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Specialized kit | Device | The kit used in the study contains:
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| Measure | Description | Time Frame |
|---|---|---|
| Sexual quality of life at 3 months between kit and no kit | 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 allĂ 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual quality of life after 3 months of specialized kit's use | 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 allĂ 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique de l'Estrée | Recruiting | Stains | 93240 | France |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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During the first phase the design is parallel with a comparison between two study groups (one with the specialized kit and one without), then all patients will be given the kit and followed for six months.
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| From reception of the kit to 3 months afterwards |
| Evaluating the use of the Endo-Sexo kit over a 3 months period | Frequency of use of the kit's various components during the first 3 months of use (based on information entered into the EndoDoute app) | From reception of the kit to 3 months afterwards |
| Pelvic pain modulation by specialized kit's use over 3 months | 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. | From enrollement to 3 months afterwards |
| Long-term effect of the specialized kit on sexual quality of life | 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 allĂ 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 |
| Need for additional medical care with and without the use of the specialized kit | 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. | From enrollement to 3 months afterwards |
| Incidence of treatment-emergent adverse events | Incidence of treatment-emergent adverse events between the group using the kit and the group not using the kit at 3 months. | From enrollment to 3 months afterwards |
| D000091662 | Genital Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |