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

Lucine

Status

Unknown

Conditions

Pelvic Pain

Chronic Pain

Endometriosis

Treatments

Device: Endocare

Device: Digital control

Study type

Interventional

Funder types

Industry

Identifiers

NCT05172492

2021-A02358-33

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.