Pelvic Pain Associated With Endometriosis or AdenomyosisELECTRENCT07393295
Efficacy and Tolerability of TENS in Endometriosis-related Pain
A study testing Conventional TENS and Microstimulation TENS in people with Pelvic Pain Associated With Endometriosis or Adenomyosis and Pelvic Pain Associated With Refractory Endometriosis, run by Monath Electronic at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Pain Associated With Endometriosis or Adenomyosis, Pelvic Pain Associated With Refractory Endometriosis, Endometriosis
- What is being tested?
- Conventional TENS and Microstimulation TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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")
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
IFEM Endo, Clinique Tivoli-Ducos
Bordeaux, 33000
Benjamin MERLOT, +33-564100945, benjamin.merlot@ifemendo.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Pelvic Pain Associated With Endometriosis or Adenomyosis, Pelvic Pain Associated With Refractory Endometriosis, Endometriosis
- Being tested
- Conventional TENS, Microstimulation TENS
- Medical subject headings
- Adenomyosis, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional TENSDevice
Every TENS treatment lasts for 45 minutes
Microstimulation TENSDevice
Every TENS treatment lasts for 45 minutes
| Study group | Role | What they receive |
|---|---|---|
| Conventional TENS Group | Experimental | Conventional TENS for 4 weeks Receives: Device: Conventional TENS |
| Microstimulation TENS | Active comparator | Microstimulation TENS for 4 weeks Receives: Device: Microstimulation TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start15 Mar 2026
- Primary completion15 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Pain Associated With Endometriosis or AdenomyosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monath Electronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bejamin MERLOT, Principal investigator, IFEM Endo, Clinique Tivoli-Ducos, 5 rue Auguste Poirson, 33000 Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393295
- Sponsor's protocol ID
- 2025-A02028-41
- Other IDs
- AU 2080
- Acronym
- ELECTRE
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Tolerability of a Transcutaneous Electrical Nerve Stimulation (TENS) Device for the Management of Endometriosis-associated Pain
- ClinicalTrials.gov ID
- NCT07393295
- Acronym / sponsor ID
- ELECTRE / 2025-A02028-41
- Conditions
- Pelvic Pain Associated With Endometriosis or Adenomyosis, Pelvic Pain Associated With Refractory Endometriosis, Endometriosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Monath ElectronicIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional TENS Group | Experimental | Device: Conventional TENSConventional TENS for 4 weeks |
| Microstimulation TENS | Active comparator | Device: Microstimulation TENSMicrostimulation TENS for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional TENSEvery TENS treatment lasts for 45 minutes | Device | Conventional TENS Group |
| Microstimulation TENSEvery TENS treatment lasts for 45 minutes | Device | Microstimulation TENS |
Primary outcome
Change in the mean value of average pain
Time frame: 56 days
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bejamin MERLOT principal investigator
IFEM Endo, Clinique Tivoli-Ducos, 5 rue Auguste Poirson, 33000 Bordeaux, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional TENS and Microstimulation TENS in people with Pelvic Pain Associated With Endometriosis or Adenomyosis and Pelvic Pain Associated With Refractory Endometriosis, run by Monath Electronic at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas LOBSTEIN (+33-389497361, thomas.lobstein@monath-electronic.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the mean value of average pain (time frame: 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.