Treatment of Chronic Pelvic Pain Due to Endometriosis by Transcutaneous Auricular Vagus Nerve Stimulation

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 15
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hopital Foch
RECRUITING
Suresnes
Contact Information
Primary
Marie-Christine DJIAN, MD
drci.promotion@hopital-foch.com
0033 1 46 25 19 22
Time Frame
Start Date: 2021-12-13
Estimated Completion Date: 2025-04
Participants
Target number of participants: 72
Treatments
Experimental: Transcutaneous auricular vagus nerve stimulation
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.
No_intervention: Standard treatment
Patients of this arm will continue their standard treatment.
Related Therapeutic Areas
Sponsors
Leads: Hopital Foch

This content was sourced from clinicaltrials.gov