NCT04177511Recruiting
Treatment of Chronic Pelvic Pain Due to Endometriosis by Transcutaneous Auricular Vagus Nerve Stimulation
Source: ClinicalTrials.gov · Last updated 21 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- First submitted
- 13 Nov 2019
- Start date
- 13 Dec 2021
- Primary completion date
- 28 Mar 2027
- Lead sponsor
- Hopital Foch
- Diseases
- Endometriosis
- NCT number
- NCT04177511
What you commit to
- Study type: Interventional
- Planned participants: 72
- From 13 Dec 2021 to the primary completion date, 28 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- patient with atria trans vagal neurostimulation in the 12 months prior to inclusion
Other illness
- contraindication to the use of transcutaneous auricular vagus nerve stimulation (cardiac pathology, asthmatic patient)
Other
- pregnant or breastfeeding women
- patient undergoing in vitro fertilization
- associated pathology requiring long-term analgesic treatment
- patient deprived of liberty or under guardianship
Who the study is looking for
- 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
Age in the registry: 15 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Foch Coordinator of this site? Confirm its status | Suresnes | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.