Informations générales (source: ClinicalTrials.gov)
Treatment of Chronic Pelvic Pain Due to Endometriosis by Transcutaneous Auricular Vagus Nerve Stimulation (Stim-Endom)
Interventional
N/A
Hopital Foch (Voir sur ClinicalTrials)
décembre 2021
avril 2025
01 août 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | MIREILLE MICHEL-CHERQUI | 05/05/2025 07:12:05 | Contacter | ||
Critères
Femme
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
- 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
- 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