Clinical trial NCT04602559: Exploratory Study : to Evaluate the Panty MOBIDERM in Patients With Pelvic and/or Genital Lymphedema
Official title: Exploratory Study to Evaluate the Clinical Benefits of Wearing the Panty MOBIDERM in Patients With Pelvic and/or Genital Lymphedema : OLYMPY Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema of Genitalia
Keywords: genital lymphedema
panty
compression
volume reduction
quality of life
pelvic lymphedema
Lead sponsor: Thuasne
Sponsor class: INDUSTRY
First posted: 2020-10-26
Enrollment: 32
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life (QoL): Patient's opinion on Global Impression of Change (PGI-C)
timeFrame: 90 days
Secondary outcomes:
measure: Quality of life (QoL): Lymphedema Quality of Life Inventory (LyQLI) self-questionnaire
timeFrame: day : 0, 30, 90
measure: Swelling, tension, discomfort and feeling of heaviness :Visual Analog Scale (VAS)
timeFrame: day : 0, 30, 90
measure: Impact of lymphedema on sexual life : Visual Analog Scale (VAS)
timeFrame: day : 0, 30, 90
measure: Pain : Visual Analog Scale (VAS)
timeFrame: day : 0, 30, 90
measure: Sleep quality : Jenkins self-questionnaire
timeFrame: day : 0, 30, 90
measure: Doctors' opinion on the change of patient's health condition (Clinical Global Impression -Improvement)
timeFrame: day : 30, 90
measure: Characteristic of pelvic lymphedema : Genital Lymphedema Score (GLS)
timeFrame: day : 0, 30, 90
measure: Pelvic/genital lymphedema perimetry for men only : Whitaker tool
timeFrame: day : 0, 30, 90
measure: Day and NIght Compliance to treatment
timeFrame: day : 30,90
measure: Satisfaction about the device: specific self questionnaire
timeFrame: Day : 30
measure: Safety: Adverse Device Effects
timeFrame: day : 0, 30, 90
measure: Quality of life (QoL): EQ-5D-5L questionnaire
timeFrame: day : 0, 30, 90
Other outcomes:
Locations:
city: Montpellier Cedex 5
country: France
facility: CHU Montpellier - Hôpital St Eloi - Service Maladies Vasculaires
city: Paris
country: France
facility: Hôpital Cognacq-Jay - unité de lymphologie
city: Toulouse
country: France
facility: CHU TOULOUSE - service médecine vasculaire
Study officials:
affiliation: University Hospital, Montpellier
name: SANDRINE MESTRE, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garaffa G, Christopher N, Ralph DJ. The management of genital lymphoedema. BJU Int. 2008 Aug;102(4):480-4. doi: 10.1111/j.1464-410X.2008.07559.x. Epub 2008 Mar 5.
citation: Facio MF, Spessoto LC, Gatti M, Ferraz Arruda PF, Ferraz Arruda JG, Antoniassi TS, Bogdan AP, Godoy MF, Godoy JM, Facio FN Jr. Clinical Treatment of Penile Fibrosis After Penoscrotal Lymphedema. Urol Case Rep. 2017 Jan 5;11:14-16. doi: 10.1016/j.eucr.2016.12.001. eCollection 2017 Feb.
citation: Shim TN, Doiron PR, Francis N, Minhas S, Muneer A, Hawkins D, Dinneen M, Bunker CB. Penile lymphoedema: approach to investigation and management. Clin Exp Dermatol. 2019 Jan;44(1):20-31. doi: 10.1111/ced.13609. Epub 2018 Jul 15.