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

NCT04602559 | Completed

• 2 other identifiers: EC31ANSM
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

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.

Conditions

Lymphedema of Genitalia

Keywords

genital lymphedema; panty; compression; volume reduction; quality of life; pelvic lymphedema

Outcome Measures

Primary Outcomes (1)

• Quality of life (QoL): Patient's opinion on Global Impression of Change (PGI-C)

  The patient's impression of overall change is measured by the Patient's opinion on Global Impression of Change questionnaire. The scale has 7 levels of response : "no change or condition has got worse" that is the worst outcome (= 1 point) "almost the same, hardly any change at all" (= 2 points); "a little better , but no noticeable change" (= 3 points); "somewhat better, but the change has not made any real difference" (= 4 points); "moderately better, and a slight but noticeable change" (= 5 points); "better, and a definite improvement that has made a real and worthwhile difference (=6 points) "A great deal better, and a considerable improvement that has made all the diiference" (=7 points) The highest score corresponds to the most improvement in quality of life.

  90 days

Secondary Outcomes (12)

• Quality of life (QoL): Lymphedema Quality of Life Inventory (LyQLI) self-questionnaire

  day : 0, 30, 90

• Swelling, tension, discomfort and feeling of heaviness :Visual Analog Scale (VAS)

  day : 0, 30, 90

• Impact of lymphedema on sexual life : Visual Analog Scale (VAS)

  day : 0, 30, 90

• Pain : Visual Analog Scale (VAS)

  day : 0, 30, 90

• Sleep quality : Jenkins self-questionnaire

  day : 0, 30, 90

Study Arms (1)

MOBIDERM Panty group

EXPERIMENTAL

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.

Device: MOBIDERM Panty group

Interventions

MOBIDERM Panty group 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).

MOBIDERM Panty group

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant woman or woman of childbearing age without contraception
• 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 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

Sponsors & Collaborators

• Thuasne: lead

Study Sites (3)

CHU Montpellier - Hôpital St Eloi - Service Maladies Vasculaires

Montpellier, 34295, France

Location

Hôpital Cognacq-Jay - unité de lymphologie

Paris, 75015, France

Location

CHU TOULOUSE - service médecine vasculaire

Toulouse, France

Location

Related Publications (4)

• 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.

  PMID: 18325055 BACKGROUND

• 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.

  PMID: 28083477 BACKGROUND

• 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.

  PMID: 30009576 BACKGROUND

• Mestre S, Vignes S, Malloizel-Delaunay J, Abba S, Villet S, Picolet A, Vicaut E, Quere I. Positive Impact of a New Compressive Garment in Patients with Genital Lymphedema: OLYMPY Study. Lymphat Res Biol. 2024 Apr;22(2):138-146. doi: 10.1089/lrb.2023.0055. Epub 2024 Apr 2.

  PMID: 38563697 DERIVED

Study Officials

• SANDRINE MESTRE, MD PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 26, 2020
• Study Start: December 3, 2020
• Primary Completion: July 9, 2021
• Study Completion: July 9, 2021
• Last Updated: January 26, 2022

Record last verified: 2022-01

Locations

FR (3)