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| Name | Class |
|---|---|
| Biotrial | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endocare | Experimental |
| |
| Digital control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endocare | Device | Endocare will be administred through a virtual reality headseat used one to twice a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity change | The mean change in pain intensity assessed by a numeric rating scale (pain intensity numerical scale) between the pre-treatment measurement and one hour after the use of Endocare treatment, compared to the digital control during the five days of treatment.The pain scale is a 11-point numeric scale (0=no pain; 10=unbearable pain). | Time points are before treatment (Time 0) and one hour after treatment (Time 1) during t five days (Day 1, Day 2, Day 3, Day 4, Day 5) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain intensity | Change in pain intensity assessed by numeric scale. The pain scale is a 11-point numeric scale (0=no pain; 10=unbearable pain). | at wake-up and bedtime during the 5 days of treat (Day 1 to Day 5) |
| Change in pain relief |
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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):
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Tivoli Ducos | Recruiting | Bordeaux | Gironde | 33000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37260160 | Derived | Merlot B, Elie V, Perigord A, Husson Z, Jubert A, Chanavaz-Lacheray I, Dennis T, Cotty-Eslous M, Roman H. Pain Reduction With an Immersive Digital Therapeutic in Women Living With Endometriosis-Related Pelvic Pain: At-Home Self-Administered Randomized Controlled Trial. J Med Internet Res. 2023 Jun 28;25:e47869. doi: 10.2196/47869. |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D059350 | Chronic Pain |
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Digital control | Device | Digital control will be administred through a virtual reality headseat used one to twice a day. |
|
Change in pain relief assessed by Likert pain relief scale. Its a 5-point categorical scale (0: no relief, 1: slight relief, 2: moderate relief, 3: lots of relief and 4: complete relief)
| At 1 hour (Time 1), 2 hours (Time 2) and 3 hours (Time 3) after treatment during the 5 days of treatment (Day 1 to Day 5) |
| Weighted average change in pain intensity | Weighted average change (based on number of treatments Endocare or control uses) in pain intensity assessed by numeric scale. The pain scale is a 11-point numeric scale (0=no pain; 10=unbearable pain). | from pre-treatment (Time 0) to 2 hours (Time 2) and 3 hours (Time 3) post-treatment during the 5 days of treatment (Day 1 to Day 5) |
| Change in stress value | Change in stress assessed by Visual Analogue Scale (VAS). Visual Analogue Scale (VAS) consists of a small unmarked 100 mm ruler with ends labelled 'none' and 'as bad as possible'. | at wake-up and bedtime during the 5 days of treatment (Day 1 to Day 5) |
| Change in fatigue value | Change in stress assessed by Visual Analogue Scale (VAS) and fatigue assessed by Pichot Scale. The Pichot scale evaluates 8 fatigue items ranging from 0 to 4 (0: not at all; 1: a little; 2: moderately; 3: a lot; 4: extremely) | at wake-up and bedtime during the 5 days of treatment (Day 1 to Day 5) |
| Change in endometriosis-related quality of life | Change in endometriosis-related quality of life assessed by Endometriosis Health Profile (EHP-5). The EHP-5 consists of 11 items ranging from "never" to "always" | At inclusion visit Day 0 and at through study completion (Day 6), an average of one week |
| Assessment of the predictive value of dramatization and catastrophizing thoughts | Assessment of the predictive value of dramatization and catastrophizing thoughts assessed by Patient catastrophizing scale (PCS) coonsisting of 13 items ranging from 0 to 4 (0= not at all; 1= to a slight degree; 2= to a moderate degree; 3= to a great degree; 4 = all the time). | At the inclusion visit Day 0 |
| Pain relief treatments | Number, frequency and dosage of pain relief treatments assessed by patient diary | during the five days of treatment (Day 1 to Day 5) at bedtime |
| Assessment of satisfaction | Assessment of satisfaction by Likert scale. It is a 7-point Likert scale (1: extremely dissatisfied, 2: very dissatisfied, 3: dissatisfied, 4: neutral, 5: satisfied, 6: very satisfied, 7: extremely satisfied). | through study completion (Day 6), an average of one week |
| Assessment of Clinical Global Impression of Improvement | Assessment of Clinical Global Impression of Improvement by CGI scale. It is a 7-point scale (1=very much improved; 7=very much worse) | through study completion (Day 6), an average of one week |
| Incidence of adverse events and treatment adherence | Incidence of adverse events and treatment adherence collected by patients diary and phone | during the five days of treatment (Day 1 to Day 5) |
| D000091662 | Genital Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |