Efficacy and Tolerability of TENS in Endometriosis-related Pain (ELECTRE)

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.

Study Overview

• Status: Recruiting
• Conditions: Endometriosis; Pelvic Pain Associated With Refractory Endometriosis; Pelvic Pain Associated With Endometriosis or Adenomyosis
• Intervention / Treatment: Device: Conventional TENS; Device: Microstimulation TENS

Detailed Description

• Endometriosis is defined by the presence of endometrial tissue outside the uterine cavity. It affects 6% to 10% of women of childbearing age. Depending on its location, a distinction is made between superficial endometriosis, adenomyosis, and deep endometriosis. The potential mechanisms of endometriosis are still under discussion.
• Endometriosis is accompanied by a painful triad combining dysmenorrhea, dyspareunia, and chronic pelvic pain.
• Pain requires treatment due to its multiple impacts in terms of quality of life, anxiety, depression, loss of productivity at work, and absenteeism.
• Approximately one-third of women with endometriosis continue to suffer despite medical treatment.
• The pain of endometriosis is multifactorial, involving inflammatory, nociceptive, neuropathic, neurovascular, myofascial, and hormonal mechanisms. The recurrence of endometriosis-related pain means that it must be considered a chronic pain syndrome leading to peripheral and central neural sensitization. The intensity of the pain is not correlated with the severity of the disease.
• Transcutaneous electrical nerve stimulation (TENS) is a non-invasive, easy-to-use, well-tolerated, self-administered technique widely used for its analgesic effect in acute and chronic pain. Several studies have suggested the effectiveness of TENS in the management of pelvic pain related to endometriosis, but they are of uneven quality.
• Evaluating the effectiveness of TENS in the management of endometriosis-related pain under the best methodological conditions remains essential.

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas LOBSTEIN; Phone Number: +33-389497361; Email: thomas.lobstein@monath-electronic.fr

Study Locations

• France
  • Bordeaux, France, 33000
    • Recruiting
    • IFEM Endo, Clinique Tivoli-Ducos
    • Contact: Benjamin MERLOT; Phone Number: +33-564100945; Email: benjamin.merlot@ifemendo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Women aged ≥ 18 years
2. Endometriosis and/or adenomyosis diagnosed by imaging and/or histology
3. Undergoing continuous, stable, and functional hormone treatment (with no menstruation) for at least 2 months
4. No change in hormone treatment planned for the duration of the study
5. Chronic pelvic pain for more than 6 months
6. Pelvic pain at least equal to 2 out of 3 (on the intensity scale: "0 - None," "1 - Mild," "2 - Moderate," "3 - Severe")
7. Agreeing to participate in the study
8. Agrees to limit pain relief treatment during the study to level I painkillers paracetamol and Acupan® (nefopam), and the NSAID Antadys® (flurbiprofen)
9. Has a computer, tablet, or cell phone with an internet connection
10. Is affiliated with a social security system or is a beneficiary of such a system

Exclusion Criteria:

1. Pregnant or breastfeeding women
2. Menopausal women
3. Patients who, in the investigator's opinion, have experienced an acute worsening of endometriosis symptoms in the last 28 days
4. Patients with altered sensitivity in the area where the device is applied (hypoesthesia)
5. Skin allergy to the gel or electrodes
6. Dermatological problem in the stimulation area
7. Patients with an implanted pacemaker or active implanted medical device.
8. Epilepsy
9. Current thrombophlebitis or arterial thrombosis
10. Cancer or malignant disease with an expected survival of < 12 months
11. Alcoholism or drug addiction
12. Fibromyalgia
13. Women who have already tried TENS
14. Patients unable to understand and use the English language to communicate fluently
15. Patients with cognitive impairments
16. Untreated severe psychiatric illness and/or psychological condition that is the primary determinant of the patient's condition
17. Participation in another intervention study that may impact the results of the current study
18. Patient using > 90 morphine equivalents/day (at least once in the last 28 days)
19. Gynecological and/or endometriosis surgery planned within the next 3 months
20. History of endometriosis surgery within the last 6 months
21. Patient who has undergone a hysterectomy or bilateral oophorectomy
22. Patient under legal protection (guardianship or conservatorship) or patient deprived of liberty

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conventional TENS Group; Conventional TENS for 4 weeks	Device: Conventional TENS; Every TENS treatment lasts for 45 minutes
Active Comparator: Microstimulation TENS; Microstimulation TENS for 4 weeks	Device: Microstimulation TENS; Every TENS treatment lasts for 45 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the mean value of average pain	Change in the mean value of average pain over the previous 24 hours, measured daily during the P1 investigation phase (between D1 and D28±2), compared with the run-in period (between D-35 and D-8). Participants will assess their average pain over the past 24 hours on a 100 mm visual analog scale (VAS) every day. The average of these daily values will be calculated over the run-in period (between D-35 and D-8), during the P1 investigation phase (between D1 and D28±2), and during the P2 extension phase (between D29±2 and D56±2). The visual analog scale will be available on the data collection tool/website provided and accessible throu PC, tablet or smartphone. The VAS is presented as a 100 mm horizontal line with no boundaries, marked at the left end with "no pain" and at the other end with "worst pain imaginable." Repeated pain measurements during the run-in period will provide a reliable baseline value that takes into account daily variations.	56 days

Collaborators and Investigators

• Sponsor: Monath Electronic
• Investigators: Principal Investigator: Bejamin MERLOT, IFEM Endo, Clinique Tivoli-Ducos, 5 rue Auguste Poirson, 33000 Bordeaux, France

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 23, 2026
• First Submitted That Met QC Criteria: January 30, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Adenomyosis; Endometriosis
• Other Study ID Numbers: 2025-A02028-41; AU 2080 (Other Identifier: CPP (Comité de protection des personnes Sud-Est VI))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No