Back to results

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

Primary Purpose

Lymphedema of Genitalia

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

MOBIDERM Panty group

About this trial

This is an interventional treatment trial for Lymphedema of Genitalia focused on measuring genital lymphedema, panty, compression, volume reduction, quality of life, pelvic lymphedema

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU Montpellier - Hôpital St Eloi - Service Maladies Vasculaires
Hôpital Cognacq-Jay - unité de lymphologie
CHU TOULOUSE - service médecine vasculaire

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MOBIDERM Panty group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

The evolution of quality of life is measured by the lymphedema Quality of life Inventory self-questionnaire. This tool is designed as a patient-completed questionnaire. It comprises 45 items. Forty-one items are divided into three multi-item domains: physical (12 questions), psychosocial (16 questions), and practical (13 questions). For each item, the impact of lymphedema over the last 4 weeks is assessed on a 4-point Likert scale (0: None, 1: A little bit, 2: Somewhat, 3: A lot). Scores are presented as the mean for each domain, ranging from 0.0 to 3.0. A higher score indicates lower QoL. The questionnaire also includes four global questions, of which item 44 assesses the overall experience of lymphedema and item 45 the overall quality of life, both on a 4-point Likert scale ranging from 0:Very bad to 3: Very good. A higher score indicates higher QoL.

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

Evolution of swelling, tension, discomfort, feeling of heaviness are measured by a visual analog scale : 0 corresponds to no discomfort/no problem (better outcome) and 10 to maximum discomfort/maximum problem (worst outcome)

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

The impact of lymphedema on patients sexual life is measured by a visual analog scale : 0 corresponds to no discomfort (better outcome) and 10 to maximum discomfort preventing sexual relation (worst outcome)

Pain : Visual Analog Scale (VAS)

Evolution of pain is measured by VAS : 0 corresponds to no pain and 10 to the maximum pain.

Sleep quality : Jenkins self-questionnaire

The evolution of sleep quality is measured by Jenkins self-questionnaire. This scale is composed of four questions about the quality of sleep. Each answer is scored from 0 to 5 (0=none; 1= 1-3 days; 2 = 4-7 days; 3 = 8-14 days; 4 = 15-21 days; 5 = 22-31 days) A higher score corresponds to a bad quality of sleep.

Doctors' opinion on the change of patient's health condition (Clinical Global Impression -Improvement)

Doctors' opinion on the change of patient's health condition due to lymphedema is measured by the Clinical Global Impression - Improvement questionnaire. The scale has 7 levels of answer from "very strongly improved" which is the better outcome (= 1 point) to "very strongly aggravated" which is the worst outcome (= 7 points) .Intermediate levels are: " Significantly improved "(= 2 points) ; " Slightly improved " (= 3 points) ; " No improvement " (=4 points) ; " Slightly worsen " (=5 points) ; " Seriously worsen" ( = 6 points). The highest score corresponds to the most impairment in quality of life.

Characteristic of pelvic lymphedema : Genital Lymphedema Score (GLS)

The evolution of pelvic lymphedema characteristics is measured by GLS questionnaire including different fields (feeling of heaviness, feeling of tension, swelling, urinary disorders, lymphatic papillomatosis, genital lymphorrhea), and by taking pictures. (0= absence of the symptom,1 or 2 = presence of the symptom)

Pelvic/genital lymphedema perimetry for men only : Whitaker tool

The evolution of the pelvic/genital lymphedema is measured by perimetric measurements according to the Whitaker tool : Measure A: middle of the scrotum Measure B: scrotal neck size Measure C: length of the scrotum

Day and NIght Compliance to treatment

Compliance to treatment is reported by the physician in the electronic Case Report Forms (eCRF) according to the patient diary. The compliance is measured by calculating the number of days and nights corresponding to a wearing of the device The average wearing time is : Full day/night, >50% of the day/night,<50% of the day/night, not at all

Satisfaction about the device: specific self questionnaire

Patient's and doctor's satisfaction with regards to MOBIDERM Panty by a satisfaction questionnaire. This questionnaire is focused on the product positioning and the comfort. These are qualitative variables; there is no score.

Safety: Adverse Device Effects

Number and type of serious and non-serious Adverse Device Effects (ADE) are reported all along the study.

Quality of life (QoL): EQ-5D-5L questionnaire

The evolution of quality of life is measured by the EQ-5D-5L questionnaire. The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems (Level 1 is coded as a '1'), slight problems (Level 2 is coded as a '2'), moderate problems (Level 3 is coded as a '3'), severe problems (Level 4 is coded as a '4'), and extreme problems (Level 5 is coded as a '5'). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions.The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS is measured by VAS : 100 corresponds to the best health and 0 to the the worst health.

Full Information

NCT ID

NCT04602559

First Posted

October 20, 2020

Last Updated

January 10, 2022

Sponsor

Thuasne

1. Study Identification

Unique Protocol Identification Number

NCT04602559

Brief Title

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

Acronym

OLYMPY

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

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

December 3, 2020 (Actual)

Primary Completion Date

July 9, 2021 (Actual)

Study Completion Date

July 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Thuasne

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphedema of Genitalia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MOBIDERM Panty group

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

MOBIDERM Panty group

Intervention Description

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).

Primary Outcome Measure Information:

Title

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

Description

Time Frame

90 days

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

day : 0, 30, 90

Title

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

Description

Time Frame

day : 0, 30, 90

Title

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

Description

Time Frame

day : 0, 30, 90

Title

Pain : Visual Analog Scale (VAS)

Description

Evolution of pain is measured by VAS : 0 corresponds to no pain and 10 to the maximum pain.

Time Frame

day : 0, 30, 90

Title

Sleep quality : Jenkins self-questionnaire

Description

Time Frame

day : 0, 30, 90

Title

Doctors' opinion on the change of patient's health condition (Clinical Global Impression -Improvement)

Description

Time Frame

day : 30, 90

Title

Characteristic of pelvic lymphedema : Genital Lymphedema Score (GLS)

Description

Time Frame

day : 0, 30, 90

Title

Pelvic/genital lymphedema perimetry for men only : Whitaker tool

Description

Time Frame

day : 0, 30, 90

Title

Day and NIght Compliance to treatment

Description

Time Frame

day : 30,90

Title

Satisfaction about the device: specific self questionnaire

Description

Time Frame

Day : 30

Title

Safety: Adverse Device Effects

Description

Number and type of serious and non-serious Adverse Device Effects (ADE) are reported all along the study.

Time Frame

day : 0, 30, 90

Title

Quality of life (QoL): EQ-5D-5L questionnaire

Description

Time Frame

day : 0, 30, 90

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

SANDRINE MESTRE, MD PhD

Organizational Affiliation

University Hospital, Montpellier

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Montpellier - Hôpital St Eloi - Service Maladies Vasculaires

City

Montpellier Cedex 5

ZIP/Postal Code

34295

Country

France

Facility Name

Hôpital Cognacq-Jay - unité de lymphologie

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

CHU TOULOUSE - service médecine vasculaire

City

Toulouse

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

18325055

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.

Results Reference

background

PubMed Identifier

28083477

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.

Results Reference

background

PubMed Identifier

30009576

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.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs