Testing a nerve stimulation device for endometriosis-related pelvic pain
Tests a pain-relief electrical device in adults with endometriosis-related pelvic pain.
Plain-language title generated from the registry record
Registry title: Efficacy and Tolerability of TENS in Endometriosis-related Pain
Key facts
- Where
- Bordeaux, FranceSee the site
Where in France
- IFEM Endo, Clinique Tivoli-DucosBordeaux, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Monath Electronic
- Trial code
- NCT07393295
- Record updated
- 31 March 2026
- Original description
ELECTRE is a single-center, randomized, prospective, longitudinal, controlled, two-arm, single-blind study lasting 4 weeks (P1 investigation phase) after a 4-week run-in period.Read full original descriptionShow less
Evaluation of the Efficacy and Tolerability of a Transcutaneous Electrical Nerve Stimulation (TENS) Device for the Management of Endometriosis-associated Pain
ELECTRE is a single-center, randomized, prospective, longitudinal, controlled, two-arm, single-blind study lasting 4 weeks (P1 investigation phase) after a 4-week run-in period.
The study is followed by a 4-week extension phase (P2) in which all participants will be treated with active TENS.
Randomization will be balanced according to a 1:1 ratio.
Inclusion: Women aged ≥ 18 years; Endometriosis and/or adenomyosis diagnosed by imaging and/or histology; Undergoing continuous, stable, and functional hormone treatment (with no menstruation) for at least 2 months; No change in hormone treatment planned for the duration of the study; Chronic pelvic pain for more than 6 months; Pelvic pain at least equal to 2 out of 3 (on the intensity scale: "0 - None," "1 - Mild," "2 - Moderate," "3 - Severe"); Agreeing to participate in the study; Agrees to limit pain relief treatment during the study to level I painkillers paracetamol and Acupan® (nefopam), and the NSAID Antadys® (flurbiprofen); Has a computer, tablet, or cell phone with an internet connection; Is affiliated with a social security system or is a beneficiary of such a system.
Exclusion: Alcoholism or drug addiction; Gynecological and/or endometriosis surgery planned within the next 3 months; Skin allergy to the gel or electrodes; Epilepsy; Current thrombophlebitis or arterial thrombosis; Cancer or malignant disease with an expected survival of < 12 months; Untreated severe psychiatric illness and/or psychological condition that is the primary determinant of the patient's condition; History of endometriosis surgery within the last 6 months; Pregnant or breastfeeding women; Menopausal women; Patients who, in the investigator's opinion, have experienced an acute worsening of endometriosis symptoms in the last 28 days; Patients with altered sensitivity in the area where the device is applied (hypoesthesia); Dermatological problem in the stimulation area; Patients with an implanted pacemaker or active implanted medical device; Fibromyalgia; Women who have already tried TENS; Patients unable to understand and use the English language to communicate fluently; Patients with cognitive impairments; Participation in another intervention study that may impact the results of the current study; Patient using > 90 morphine equivalents/day (at least once in the last 28 days); Patient who has undergone a hysterectomy or bilateral oophorectomy; Patient under legal protection (guardianship or conservatorship) or patient deprived of liberty.