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

Last updated: January 3, 2022
Sponsor: Lucine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dysmenorrhea (Painful Periods)

Endometriosis

Chronic Pain

Treatment

N/A

Clinical Study ID

NCT05172492
2021-A02358-33
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women over 18 years of age with diagnosed endometriosis (histology, imaging, clinicalsymptomatology) and/or adenomyosis.
  • Women with at least 2 consecutive days per month of endometriosis-relatedpelvic-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

Exclusion Criteria:

  • Pregnant or nursing women.
  • Women participating, or who have participated, in a clinical interventional studywithin 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.

Study Design

Total Participants: 120
Study Start date:
December 07, 2021
Estimated Completion Date:
September 30, 2022

Connect with a study center

  • Clinique Tivoli Ducos

    Bordeaux, Gironde 33000
    France

    Active - Recruiting

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