An Open-Label, Interventional, Controlled Study To Assess The Performance And Tolerance Of Pixel CO2-Alma Fractionated Laser in Women Affected by GenitoUrinary Syndrome of Menopause (GSM)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Vaginal dryness by Visual Analogue Scale
研究概览
简要总结
Genitourinary syndrome of menopause (GSM) occurs in approximately 50% of menopausal women but is both underrecognized and undertreated despite numerous treatment options. Vaginal dryness, irritation, dyspareunia, urinary frequency, and urinary urgency are some of the more common symptoms that can have a negative effect on women's lives and relationships. In particular, dyspareunia is localized in the vestibule with specific trophic changes more evident than those localized in vagina. The CO2 fractionated laser, has also been found to be useful in several studies for the treatment of vaginal atrophy.
In this open comparative study, 70 female menopausal subjects aged between 40 and 70 years old at inclusion, having symptoms of GSM (Vaginal dryness, burning/pain, dyspareunia,dysuria), have given her informed consent and meet all the eligibility criteria, will be enrolled. The two groups of comparison will be 35 subjects treated into vagina and vestibule, versus 35 subjects treated into vagina, only. Subjects will come to a total of 6 visits over a period of 3 months.
The primary objective of the study is to evaluate the performance and safety of Pixel CO2-Alma Fractionated Laser comparing its administration into vagina and vestibule versus into vagina, only. The evaluated outcomes are vaginal dryness, burning/pain, dyspareunia, sensitivity to touch at Swab test, Female Sexual Function Index (FSFI) and Vulval Pain Functional Questionnaire (VQ) at day 84 and 120 and the safety during all the study. The secondary objectives are the evaluation of vaginal and vestibular trophism, measured by Vaginal Health Index (VHI) and Vestibular Health Score (VHS) at the FU visits.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •menopausal women aged between 40 and 70 years old (defined as Absence of menstruation for 12 consecutive months).
- •women affected by Genitourinary syndrome of menopause (GSM) with Vaginal dryness, burning/pain, dyspareunia, dysuria.
- •women not treated with Replacement therapy with estrogen and progestogen (HT) or estrogen alone (ET) or selective estrogen receptor modulators (SERMS) in the last 3 months
排除标准
- •hypersensitivity to laser
- •clinically significant findings on physical examination
- •any chronic medical condition or psychologic disorder that per opinion of the Principal Investigator would make the patient ineligible for the study
- •vulvo-vestibular lesion not related with GSM
- •active vaginal or vulvar infections (e.g., herpes, candida, STIs)
- •prolapse beyond the hymen
- •subject has a history of scarring alteration (ie, keloid formation)
- •unknown past or active history of vaginal bleeding disorders
- •any condition or behavior indicating to the Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits
结局指标
主要结局
Vaginal dryness by Visual Analogue Scale
时间窗: 120 days
The changing will be measured by Visual Analogue Scale (VAS) mean values from baseline to day 84 (visit 5), and 120 (final visit) in each group separately and in the two groups in comparison. The minimum score is 0 and the maximum score is 10, where 0 represents no symptoms and 10 represents severe symptoms
Vulval Pain by Vulval Pain Functional Questionnaire
时间窗: 120 days
The Vulval Pain Functional Questionnaire (VQ) will be used to quantify the extent that pelvic pain is affecting the patients. A numerical value is assigned to each response. The higher the score the greater the functional limitation. A diminishing score represents improvement.
Burning/pain by Visual Analogue Scale
时间窗: 120 days
The changing will be measured by Visual Analogue Scale (VAS) mean values from baseline to day 84 (visit 5), and 120 (final visit) in each group separately and in the two groups in comparison. The minimum score is 0 and the maximum score is 10, where 0 represents no symptoms and 10 represents severe symptoms
Dyspareunia by Visual Analogue Scale
时间窗: 120 days
The changing will be measured by Visual Analogue Scale (VAS) mean values from baseline to day 84 (visit 5), and 120 (final visit) in each group separately and in the two groups in comparison. The minimum score is 0 and the maximum score is 10, where 0 represents no symptoms and 10 represents severe symptoms
Pain/sensitivity to touch at Swab test by Visual Analogue Scale.
时间窗: 120 days
The changing will be measured by Visual Analogue Scale (VAS) mean values from baseline to day 84 (visit 5), and 120 (final visit) in each group separately and in the two groups in comparison. The minimum score is 0 and the maximum score is 10, where 0 represents no symptoms and 10 represents severe symptoms
Sexual Function by Female Sexual Function Index
时间窗: 120 days
Sexual function will be evaluated at baseline and after 84 and 120 days by the Italian validated translation of the Female Sexual Function Index (FSFI), a self-report instrument consisting of 19 items that assess sexual function over the past 4 weeks in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. Mean value in each group separately and in the two groups in comparison will be analyzed.
Incidence of Treatment-Emergent Adverse Events/ Adverse Device Events/ Serious Adverse Events/ Serious Adverse Device Events [Safety and Tolerability]
时间窗: up to 120 days
The incidence will be calculated by searching for Adverse Event (AE), Adverse Device Event ADE, Serious Adverse Event (SAE), Serious Adverse Device Event (SADE) at each visit
次要结局
- Vestibular Trophism by Vaginal Health Index(120 days)
- Vestibular Trophism by Vestibular Health Score(120 days)
研究者
Dr. Filippo Murina
Responsabile Servizio di Patologia del tratto genitale inferiore
ASST Fatebenefratelli Sacco