EndometriosisStim-EndomNCT04177511
Treatment of Chronic Pelvic Pain Due to Endometriosis by Transcutaneous Auricular Vagus Nerve Stimulation
A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Endometriosis, run by Hopital Foch at 1 site in France.
Trial summary
6-10% of women of childbearing age suffer from endometriosis, which is mainly manifested by dysmenorrhea, non-menstrual pelvic pain and dyspareunia. Several treatment strategies, including surgical ones, are proposed but they are sometimes insufficient because endometriosis-related pain is frequently accompanied by… Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2021to 28 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women aged >= 15 years
- With chronic pelvic pain and/ or dysmenorrhoea and/ or dyspareunia
- Who has been cared for by a gynecologist in one of the institutions participating in the study
- Diagnosed with endometriosis
- Having signed an informed written consent
- Affiliated to a health insurance scheme
Who cannot join
- contraindication to the use of transcutaneous auricular vagus nerve stimulation (cardiac pathology, asthmatic patient)
- pregnant or breastfeeding women
- patient undergoing in vitro fertilization
- associated pathology requiring long-term analgesic treatment
- patient with atria trans vagal neurostimulation in the 12 months prior to inclusion
- patient deprived of liberty or under guardianship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital Foch
Suresnes, Île-de-France Region, 92150
Mireille Michel-cherqui, MD, drci.promotion@hopital-foch.com
About this study
6-10% of women of childbearing age suffer from endometriosis, which is mainly manifested by dysmenorrhea, non-menstrual pelvic pain and dyspareunia. Several treatment strategies, including surgical ones, are proposed but they are sometimes insufficient because endometriosis-related pain is frequently accompanied by sensitization. Endometriosis surgery, when indicated, is therefore changeably effective, even though the lesions have been completely resected. Patients therefore consult Pain Units seeking for the effective treatment as the pain persist even after surgical management of endometriosis.
Vagus nerve stimulation is a non-invasive technique that includes an anti-inflammatory effect and a modulation of neurotransmitter production (adrenaline, norepinephrine; serotonin, acetylcholine). Yuan and Silberstein published a general review on the technique. Migraine and depression are one of the selected indications. In addition, Napadow et al. published favourable results in a short series of patients with chronic pelvic pain. The Investigators of this study have treated some patients with this technique with a result deemed satisfactory which leads to propose a randomized study to confirm this impression.
- Conditions
- Endometriosis
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulation
- Keywords
- Chronic pelvic pain, Transcutaneous Auricular Vagus Nerve Stimulation
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagus Nerve StimulationDevice
Transcutaneous Auricular Vagus Nerve Stimulation has an eartip connected to an external stimulator. The device used in this study is the TENS Eco Plus commercialized by Schwa Medico and European Compliance (CE) marked.
The electrode is positioned in the cymba concha of the left ear.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous auricular vagus nerve stimulation | Experimental | A 30-minute session twice a day during 3 months of transcutaneous auricular vagus nerve stimulation using the TENS Eco Plus.
Standard treatment will be continued by the patients of this arm. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation |
| Standard treatment | No intervention | Patients of this arm will continue their standard treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of symptoms related to the pelvic pain
Self assessement of change using Patient's Global Impression of Change (PGIC) scale in which patients rate the improvement of their symptoms related to their pelvic pain from "No change or it get worse" to "A great deal better, and a considerable improvement that has made all the difference" . A favorable result will be "Better, and a definite improvement that has made a real and worthwhile difference" or "A great deal better, and a considerable improvement that has made all the difference"
Measured: 3 months after enrolment
Secondary outcomes (9)
Efficacy on pain
Self assessement of pain using Endometriosis-associated pelvic pain scale on which patients rate their current pain intensity from 0 "No pain" to 10 "worst possible pain"
Measured: Day 1 and 3 months after enrolment
Efficacy on severity of patient's symptoms
Physician assessement of severity of patient's symptoms using Global Clinical Impressions-Severity scale on which physicians rate the severity of patient's symptoms from "not evaluated" to "Among the sickest patients"
Measured: Day 1 and 3 months after enrolment
Efficacy on quality of life
Self assessement of quality of life using Endometriosis Health Profile-5
Measured: Day 1 and 3 months after enrolment
Efficacy on quality of life
Self assessement of quality of life using EQ-5D scale
Measured: Day 1 and 3 months after enrolment
Efficacy on Anxiety
Self assessement of anxiety using the Hospital Anxiety and Depression scale
Measured: Day 1 and 3 months after enrolment
Efficacy on gynecological and pelvic pain symptoms
Self assessement of gynecological and pelvic pain symptoms using ENDOL-4D questionnaire
Measured: Day 1 and 3 months after enrolment
Efficacy on gynecological and pelvic pain symptoms
Self assessement of gynecological and pelvic pain symptoms using KESS questionnaire
Measured: D1 and 3 months after enrolment
General efficacy of the device Transcutaneous Electronic Neuro Stimulation TENS Eco Plus
Self assessement of satisfaction using a satisfaction questionnaire involving satisfaction, adherence to treatment sessions and ease of use of the device
Measured: 3 months after enrolment
Collection of possible side effects
collection of vagal malaise, nausea and vomiting
Measured: 3 months after Enrolement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start13 Dec 2021
- Primary completion28 Mar 2027 (estimated)
- Study completion28 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mireille MICHEL-CHERQUI, MD, Principal investigator, Hopital Foch, SuresnesMarc FISCHLER, MD PhD, Study chair, Hopital Foch, Suresnes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177511
- Sponsor's protocol ID
- 2019-0057
- Acronym
- Stim-Endom
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2019
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Pelvic Pain Due to Endometriosis by Transcutaneous Auricular Vagus Nerve Stimulation
- ClinicalTrials.gov ID
- NCT04177511
- Acronym / sponsor ID
- Stim-Endom / 2019-0057
- Conditions
- Endometriosis
- Keywords
- Chronic pelvic pain, Transcutaneous Auricular Vagus Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 28 Mar 2027 (estimated)
- Study completion
- 28 Mar 2027 (estimated)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
6-10% of women of childbearing age suffer from endometriosis, which is mainly manifested by dysmenorrhea, non-menstrual pelvic pain and dyspareunia. Several treatment strategies, including surgical ones, are proposed but they are sometimes insufficient because endometriosis-related pain is frequently accompanied by sensitization. Endometriosis surgery, when indicated, is therefore changeably effective, even though the lesions have been completely resected. Patients therefore consult Pain Units seeking for the effective treatment as the pain persist even after surgical management of endometriosis.
Vagus nerve stimulation is a non-invasive technique that includes an anti-inflammatory effect and a modulation of neurotransmitter production (adrenaline, norepinephrine; serotonin, acetylcholine). Yuan and Silberstein published a general review on the technique. Migraine and depression are one of the selected indications. In addition, Napadow et al. published favourable results in a short series of patients with chronic pelvic pain. The Investigators of this study have treated some patients with this technique with a result deemed satisfactory which leads to propose a randomized study to confirm this impression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous auricular vagus nerve stimulation | Experimental | Device: Transcutaneous Auricular Vagus Nerve StimulationA 30-minute session twice a day during 3 months of transcutaneous auricular vagus nerve stimulation using the TENS Eco Plus. Standard treatment will be continued by the patients of this arm. |
| Standard treatment | No intervention | –Patients of this arm will continue their standard treatment. |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Women aged >= 15 years
- With chronic pelvic pain and/ or dysmenorrhoea and/ or dyspareunia
- Who has been cared for by a gynecologist in one of the institutions participating in the study
- Diagnosed with endometriosis
- Having signed an informed written consent
Key exclusion criteria (6 listed)
- contraindication to the use of transcutaneous auricular vagus nerve stimulation (cardiac pathology, asthmatic patient)
- pregnant or breastfeeding women
- patient undergoing in vitro fertilization
- associated pathology requiring long-term analgesic treatment
- patient with atria trans vagal neurostimulation in the 12 months prior to inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve StimulationTranscutaneous Auricular Vagus Nerve Stimulation has an eartip connected to an external stimulator. The device used in this study is the TENS Eco Plus commercialized by Schwa Medico and European Compliance (CE) marked. The electrode is positioned in the cymba concha of the left ear. | Device | Transcutaneous auricular vagus nerve stimulation |
Primary outcome
Change of symptoms related to the pelvic pain
Time frame: 3 months after enrolment
Self assessement of change using Patient's Global Impression of Change (PGIC) scale in which patients rate the improvement of their symptoms related to their pelvic pain from "No change or it get worse" to "A great deal better, and a considerable improvement that has made all the difference" . A favorable result will be "Better, and a definite improvement that has made a real and worthwhile difference" or "A great deal better, and a considerable improvement that has made all the difference"
9 secondary outcomes
Efficacy on pain
Time frame: Day 1 and 3 months after enrolment
Efficacy on severity of patient's symptoms
Time frame: Day 1 and 3 months after enrolment
Efficacy on quality of life
Time frame: Day 1 and 3 months after enrolment
Efficacy on quality of life
Time frame: Day 1 and 3 months after enrolment
Efficacy on Anxiety
Time frame: Day 1 and 3 months after enrolment
Efficacy on gynecological and pelvic pain symptoms
Time frame: Day 1 and 3 months after enrolment
Efficacy on gynecological and pelvic pain symptoms
Time frame: D1 and 3 months after enrolment
General efficacy of the device Transcutaneous Electronic Neuro Stimulation TENS Eco Plus
Time frame: 3 months after enrolment
Collection of possible side effects
Time frame: 3 months after Enrolement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mireille MICHEL-CHERQUI, MD principal investigator
Hopital Foch, Suresnes
Marc FISCHLER, MD PhD study chair
Hopital Foch, Suresnes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Endometriosis, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mireille MICHEL-CHERQUI, MD (0033 1 46 25 29 85, drci.promotion@hopital-foch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of symptoms related to the pelvic pain (time frame: 3 months after enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.