A POST-MARKET, CONFIRMATORY, INTERVENTIONAL CLINICAL INVESTIGATION to EVALUATE the PERFORMANCE and SAFETY of VAGINAL FILLER for the CORRECTION of ATROPHY of the FEMALE EXTERNAL GENITAL AREAS (LABIA MAJORA), RE-PROPORTIONING the RATIO BETWEEN LABIA MINORA and LABIA MAJORA and AMELIORATING SEXUAL FUNCTIONS.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Evaluation of the performance of Vaginal Filler in improving sexual functions.
研究概览
简要总结
The overall aim of this research is to gather more information on the effectiveness of the Vaginal Filler medical device used in women to correct the thinning of the external genital tissue of the labia majora, re-proportioning its volume in relation to the labia minora and improving sexual function. It will also collect data about the safety and tolerability of Vaginal Filler.
The main question it aims to answer is:
• Does the treatment with Vaginal Filler medical device lead to an improvement of sexual functions in women with atrophy of female external genitalia (labia major)?
Researchers will compare subjects treated with Vaginal Filler medical device to untreated subjects to better study the effectiveness and also the undesirable effects of Vaginal Filler and to guarantee scientifically valid and bias-free results.
Participants will:
- receive the Vaginal Filler device via microinjections into the labia majora, if assigned to the Vaginal Filler treatment group;
- Attend the clinic for 6 scheduled visits: screening visit (V-1), baseline visit (V0) with the execution of the treatment and 4 subsequent follow-up visits (V1, V2, V3, V4) carried out 2 weeks, 1, 3 and 6 months after V0. The total duration of the study will be approximately 6 months;
- Keep a daily diary of any disorders, health problems or adverse events that may occur;
- Complete some questionnaires during the visits to the clinic.
详细描述
With the natural ageing process, the entire body is affected by structural and morphological physical changes, including the female external genitalia (vulva). These tend to wither and lose the characteristics of youthful age, compromising the sexual sphere and quality of life.
This phenomenon depends on the physiological hormonal changes typical of menopause, which inevitably lead to major aesthetic, physical and psychological changes.
The female genital apparatus, around the age of 40 to 50, changes not only due to advancing age but also due to the lack of oestrogen (the main female sex hormones), which progressively decreases until it disappears, leading to a progressive change in the structure of the vaginal and vulvar tissue.
The decrease in hyaluronic acid, elastic fibres, collagen, and the fatty layer results in a macroscopic loss of volume, noticeable skin laxity, and a change in the ratio between the labia majora and labia minora, which causes the latter to protrude more.
The reduced volume and change in the shape of the labia majora compromise their protective function of the internal structures, exposing the labia minora and vagina to microtrauma that contributes to certain menopausal symptoms such as dryness, burning, pain and itching of the innermost structures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects Informed consent form (ICF) signed;
- •Female aged 40-65 years;
- •Atrophy and/or hypotrophy of labra majora requiring volume augmentation. Hypotrophy will be preoperatively staged in mild, moderate and severe considering both the adipose tissue and the cutaneous layer;
- •Body Mass Index (BMI)<32 Kg/m2;
- •Willingness to follow all study procedures, including attending all site visits, tests and examinations.
排除标准
- •Allergy or controindications to device components;
- •Allergy or controindications to anesthetic components;
- •Previous surgery on external genitalia;
- •Infectious or inflammatory processes close to the area of the procedure;
- •History of vulvar cancer (including vulvar squamous papillomas) and/or previous regional radiotherapy;
- •Active local herpes simplex or herpes zoster infection;
- •Active herpes zoster infection in other sites;
- •Active skin allergy including local dermatitis;
- •Chronic pathological skin condition;
- •Active mycosis and others bacterial infections;
- •Immune system illnesses/disease;
- •Known hypersensitivity to cheloids;
- •Diabetes mellitus or uncontrolled systemic diseases (endocrine, hepatic renal, cardiac, pulmonary, neurological disorder);
- •Problems with coagulation or anti-coagulating therapies in progress;
- •Current treatment with substances which act on blood fluidity (eg. Aspirin, NSAIDs, Vitamin C), anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago), drugs able to influence the test results in the investigator opinion;
- •Known drug and/or alcohol abuse;
- •Mental incapacity that precludes adequate understanding or cooperation;
- •Pregnancy or breastfeeding;
- •COVID-19 vaccination within two month prior to study inclusion;
- •Participation in another investigational study within 1 month prior to study inclusion.
结局指标
主要结局
Evaluation of the performance of Vaginal Filler in improving sexual functions.
时间窗: At the end of the study (Visit V4) 6 months after enrolment.
The Female Sexual Function Index (FSFI) will be used to evaluate the improvement of sexual functions at the end-of-study visit, comparing the results between the treatment and the control group. This questionnaire consists of 19 questions addressed to the patient, who can answer with a score from 0 or 1 (worst result) to 5 (best result).
次要结局
- Evaluation of the performance of Vaginal Filler in improving sexual functions.(At V0 (Baseline visit day 0, before IP administration), V1 (2 weeks from V0), V2 (1 month from V0), V3 (3 months from V0) and V4 (6 months from V0).)
- Evaluation of the performance of Vaginal Filler in improving subjects' quality of life.(At V0 (Baseline visit day 0), V1 (2 weeks from V0), V2 (1 month from V0), V3 (3 months from V0) and V4 (6 months from V0).)
- Evaluation of the performance of Vaginal Filler in improving the shape and re-proportioning the ratio between labia minora and labia majora.(At V0 (Baseline visit day 0, before and after IP administration), V1 (2 weeks from V0), V2 (1 month from V0), V3 (3 months from V0) and V4 (6 months from V0).)
- Evaluation of the performance of Vaginal Filler for vulvar reshaping.(At V0 (Baseline visit day 0, before and after IP administration), V1 (2 weeks from V0), V2 (1 month from V0), V3 (3 months from V0) and V4 (6 months from V0).)
- Evaluation of the performance of Vaginal Filler to alleviate the symptoms of vulvar atrophy and hypotrophy.(At V0 (Baseline visit day 0), V1 (2 weeks from V0), V2 (1 month from V0), V3 (3 months from V0) and V4 (6 months from V0).)
- Evaluation of pain intensity after injection of Vaginal Filler.(At V0 (Baseline visit day 0, after IP administration))
- Evaluation of patient tolerance and satisfaction with Vaginal Filler treatment.(At End-Of-Study visit (V4) (6 months after the treatment).)
- Safety monitoring through vulva examination.(From V-1 (Screening visit Week -1) to V4 (End of Study) at 6 months.)
- Assessment of device deficiency/incidents.(At baseline visit V0 and eventually at visit V2 (in case of touch-up one month after the first treatment).)
- Collection of any adverse events and serious adverse events.(From baseline visit (V0) to the end of the study (V4) at 6 months.)
- Assessment of concomitant medications.(From screening visit (V-1) to the end of the study (V4) at 6 months.)
- Safety monitoring through vital signs by Blood Pressure.(From V-1 (Screening visit Week -1) to V4 (End of Study) at 6 months.)
- Safety monitoring through vital signs by Heart Rate.(From V-1 (Screening visit Week -1) to V4 (End of Study) at 6 months.)