Exploratory Study to Evaluate the Clinical Benefits of Wearing the Panty MOBIDERM in Patients With Pelvic and/or Genital Lymphedema : OLYMPY Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Thuasne
- 入组人数
- 32
- 试验地点
- 5
- 主要终点
- Quality of life (QoL): Patient's opinion on Global Impression of Change (PGI-C)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Quality of life (QoL): Patient's opinion on Global Impression of Change (PGI-C)
时间窗: 90 days
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.
次要结局
- Characteristic of pelvic lymphedema : Genital Lymphedema Score (GLS)(day : 0, 30, 90)
- Pelvic/genital lymphedema perimetry for men only : Whitaker tool(day : 0, 30, 90)
- Swelling, tension, discomfort and feeling of heaviness :Visual Analog Scale (VAS)(day : 0, 30, 90)
- Pain : Visual Analog Scale (VAS)(day : 0, 30, 90)
- Day and NIght Compliance to treatment(day : 30,90)
- Satisfaction about the device: specific self questionnaire(Day : 30)
- Safety: Adverse Device Effects(day : 0, 30, 90)
- Quality of life (QoL): Lymphedema Quality of Life Inventory (LyQLI) self-questionnaire(day : 0, 30, 90)
- Impact of lymphedema on sexual life : Visual Analog Scale (VAS)(day : 0, 30, 90)
- Doctors' opinion on the change of patient's health condition (Clinical Global Impression -Improvement)(day : 30, 90)
- Sleep quality : Jenkins self-questionnaire(day : 0, 30, 90)
- Quality of life (QoL): EQ-5D-5L questionnaire(day : 0, 30, 90)