RecruitingNot ApplicableNCT07393295

Efficacy and Tolerability of TENS in Endometriosis-related Pain

Evaluation of the Efficacy and Tolerability of a Transcutaneous Electrical Nerve Stimulation (TENS) Device for the Management of Endometriosis-associated Pain

Sponsor

Monath Electronic

Enrollment

92 participants

Start Date

Mar 15, 2026

Study Type

INTERVENTIONAL

Conditions

Endometriosis Pelvic Pain Associated With Endometriosis or Adenomyosis Pelvic Pain Associated With Refractory Endometriosis

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria10

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 Criteria22

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)
Skin allergy to the gel or electrodes
Dermatological problem in the stimulation area
Patients with an implanted pacemaker or active implanted medical device.
Epilepsy
Current thrombophlebitis or arterial thrombosis
Cancer or malignant disease with an expected survival of \< 12 months
Alcoholism or drug addiction
Fibromyalgia
Women who have already tried TENS
Patients unable to understand and use the English language to communicate fluently
Patients with cognitive impairments
Untreated severe psychiatric illness and/or psychological condition that is the primary determinant of the patient's condition
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)
Gynecological and/or endometriosis surgery planned within the next 3 months
History of endometriosis surgery within the last 6 months
Patient who has undergone a hysterectomy or bilateral oophorectomy
Patient under legal protection (guardianship or conservatorship) or patient deprived of liberty