Exploratory Study : to Evaluate the Panty MOBIDERM in Patients With Pelvic and/or Genital Lymphedema

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-03

Study Completion Date

2021-07-09

Brief Summary

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Lymphedema (LO) is a chronic and disabling condition that affects quality of life. This pathology has a physical, psychological, social and professional impact. Pelvic or genital lymphedema (LP/LG) is the result of a dysfunction of the lymphatic system in the genital area that can occur following surgery, radiation therapy, tumor, infections affecting the inguinal lymph nodes or related lymphatic pathways (secondary LP/LG). Urogenital cancers are the major cause of secondary LP/LG. It is difficult to have an accurate estimate of the prevalence of LP/LG. LP/LG can be painful, the edema very bulky and disharmonious. The patient is facing with significant physical and psychological difficulties. The volume of the lymphedema can be important, causing discomfort, rubbing when walking or during physical activities, disrupting daily life and may constitute a major handicap.

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Detailed Description

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Currently, there is no reference treatment which is validated for these lymphedemas, and few recommendations from the competent authorities or learned societies are available. There is no solution available on the market which covers all the needs and expectations of patients and healthcare professionals.

The Panty MOBIDERM is a standard pelvic compressive orthosis that should promote lymphatic drainage, then reduce the volume of edema, and contributing to an overall improvement in the patients' quality of life.

Conditions

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Lymphedema of Genitalia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a prospective, multicenter, interventional, open-label, prospective exploratory study in a population of patients with primary or secondary pelvic and/or genital lymphedema

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MOBIDERM Panty group

MOBIDERM Panty group :

All patients will wear the Panty MOBIDERM device for 12 weeks, day and night recommended. A removable pad is also recommended to be worn additionnaly to the panty.

Group Type EXPERIMENTAL

MOBIDERM Panty group

Intervention Type DEVICE

In the MOBIDERM Panty group, patients wear the MOBIDERM Panty during day and night for 3 months with the possibility to add the PAD.

The protocol includes 3 visits.

Visit 1 at day 0, corresponding to the inclusion visit, includes device delivery and some clinical evaluations (clinical examination, characteristics of lymphedema, self questionnaires, pain assessment, perimeter data).

Visit 2 at 30 days after the inclusion : includes some clinical evaluations (clinical examination, characteristics and evolution of lymphedema, self questionnaires, pain assessment, perimeter data, safety, compliance).

Visit 3 at 90 days after the inclusion : includes some clinical evaluations (clinical examination, characteristics and evolution of lymphedema, self questionnaires, pain assessment, perimeter data, safety, compliance).

Interventions

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MOBIDERM Panty group

In the MOBIDERM Panty group, patients wear the MOBIDERM Panty during day and night for 3 months with the possibility to add the PAD.

The protocol includes 3 visits.

Visit 1 at day 0, corresponding to the inclusion visit, includes device delivery and some clinical evaluations (clinical examination, characteristics of lymphedema, self questionnaires, pain assessment, perimeter data).

Visit 2 at 30 days after the inclusion : includes some clinical evaluations (clinical examination, characteristics and evolution of lymphedema, self questionnaires, pain assessment, perimeter data, safety, compliance).

Visit 3 at 90 days after the inclusion : includes some clinical evaluations (clinical examination, characteristics and evolution of lymphedema, self questionnaires, pain assessment, perimeter data, safety, compliance).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Primary or secondary pelvic or genital lymphedema of stage II ou III according to the criteria defined by the International Society of Lymphology.
* Patient with discomfort related to lymphedema
* Presence of the Stemmer's sign if applicable
* Patient with a morphology compatible with the 6 sizes of the MOBIDERM Panty (Minimum and maximum pelvic circumference: 88 and 129 cm respectively)
* Patient who gave signed, informed, voluntary consent prior to any intervention in the study
* Patient affiliated to the General regime of the Social Security or covered by a similar health insurance system

Exclusion Criteria

* Pregnant woman or woman of childbearing age without contraception
* Patient with surgery of the small pelvis or genitals performed within the last 3 months prior to inclusion or any surgery scheduled during the study period
* Patient with hydrocoele
* Patient who had intensive reduction therapy for lower limb lymphedema within the last month
* Patient with a contraindication to compression, such as untreated infection, skin irritation, recent thrombosis (\< 3 months), obliterative arterial disease of the lower limbs with a systolic pressure index \< 0.6, phlegmatia coerulea dolens (painful blue phlebitis with arterial compression) in the thigh area
* Patient with decompensated heart failure
* Patient with a known allergy to the components used in the Panty
* Patient with untreated or escaped cancer
* Patient with a postectomy within the last 3 months prior to inclusion
* Patient with significant edema localized only to the labia minora
* Patient with psychiatric, psychological or neurological disorders that are incompatible with proper follow-up of a clinical study
* Patient participating in other research involving the human person impacting the main judgement criteria
* Patient cannot be followed for 12 weeks
* Vulnerable patient according to article L1121-6 of the French public health code, or subject being the object of a legal protective measure or enable to express his consent freely

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No