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Endocare for Pelvic-perineal Pain Related to Endometriosis Used at Home

Unknown statusNot applicableNCT05172492
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

Women with endometriosis experience recurrent pelvic-perineal pain impairing the quality of life, among other things. Endometriosis-related pain negatively impacts the sexual, family and work life. Apart from the usual painkillers, the doctor's current therapeutic arsenal is limited to hormonal contraceptives and surgery. As endometriosis-related treatments do not currently address all of the patients' problems, developing a new, effective, non-pharmaceutical treatment would make it possible to relieve the pain of these women. Endocare treatment consists of visual and auditory therapeutic procedures for pelvic-perineal pain in patients with endometriosis. Moreover, as Endocare is not a pharmacological molecule but a digital therapy, it would not increase the consumption of pharmacological agents. An analgesic effect of Endocare lasting several hours on chronic pelvic-perineal pain associated with endometriosis is expected. The effects of the treatment will be compare to a digital control also integrated in a virtual reality headset identical to the one distributing Endocare allowing to maintain the blindness to the patients and the investigator on the treatment received.

Study details

Official title
Efficacy of Endocare Treatment at Home on Pain in Women With Chronic Pelvic-perineal Pain Related to Endometriosis. EndoHome.
Interventions
  • Device: Endocare
  • Device: Digital control
Sponsor
Lucine
Collaborators
Biotrial
Start date
2021-12-07
Primary completion
2022-09
Sex
Female
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
France
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Women over 18 years of age with diagnosed endometriosis (histology, imaging, clinical symptomatology) and/or adenomyosis. * Women with at least 2 consecutive days per month of endometriosis-related pelvic-perineal pain of moderate to severe intensity (NS ≥ 4): * Women without amenorrhea: pain around the onset of menstruation. * Women with amenorrhea: most intense pain of the month. Exclusion Criteria: * Pregnant or nursing women. * Women participating, or who have participated, in a clinical interventional study within 30 days prior to inclusion. * Women with severe visual, auditory or cognitive impairment, color blindness, photosensitivity, epilepsy or motion sickness. * Women whose pain is occasional and not present at each menstrual period. * Women who have previously received virtual reality treatments. * Women under judicial protection, guardianship, curatorship, protective mandate.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05172492