Non-invasive treatment for chronic pelvic pain from endometriosis
Treatment of Chronic Pelvic Pain Due to Endometriosis by Transcutaneous Auricular Vagus Nerve Stimulation
NA · Hopital Foch · NCT04177511
This study is testing a new non-invasive treatment using nerve stimulation to see if it can help women with chronic pelvic pain from endometriosis feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 15 Years and up |
| Sex | Female |
| Sponsor | Hopital Foch (other) |
| Locations | 1 site (Suresnes, Île-de-France Region) |
| Trial ID | NCT04177511 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of transcutaneous auricular vagus nerve stimulation as a treatment for chronic pelvic pain associated with endometriosis. The study targets women aged 15 and older who experience symptoms such as dysmenorrhea and dyspareunia, despite previous treatments. The approach aims to leverage the anti-inflammatory effects and neurotransmitter modulation provided by vagus nerve stimulation to alleviate pain. Participants will be monitored for effectiveness and safety throughout the intervention.
Who should consider this trial
Good fit: Ideal candidates are women aged 15 and older diagnosed with endometriosis and experiencing chronic pelvic pain.
Not a fit: Patients with contraindications to vagus nerve stimulation, such as certain cardiac conditions or those who are pregnant or breastfeeding, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive option for women suffering from chronic pelvic pain due to endometriosis.
How similar studies have performed: While vagus nerve stimulation has shown promise in treating conditions like migraine and depression, this specific application for endometriosis-related pain is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Suresnes, Île-de-France Region
- Hopital Foch — Suresnes, Île-de-France Region, France (RECRUITING)
Study contacts
- Principal investigator: Mireille MICHEL-CHERQUI, MD — Hopital Foch, Suresnes
- Study coordinator: Mireille MICHEL-CHERQUI, MD
- Email: drci.promotion@hopital-foch.com
- Phone: 0033 1 46 25 29 85
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Endometriosis, Chronic pelvic pain, Transcutaneous Auricular Vagus Nerve Stimulation