TREATMENT OF VAGINAL DRYNESS IN SJÖGREN'S DISEASE WITH CO2-LASER VERSUS TOPICAL PROMESTRIENE: A PROSPECTIVE RANDOMIZED STUDY
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Vaginal Health Index (VHI)
研究概览
简要总结
Sjögren's disease (SjD) is a chronic, immune-mediated, systemic inflammatory disease characterized mainly by involvement of the salivary and lacrimal glands, causing symptoms of sicca syndrome. The disease predominantly affects women (9:1 to 20:1), with a peak incidence between 40 and 60 years of age. Symptoms of dryness include those resulting from vaginitis sicca, such as vulvovaginal irritation, dryness, pruritus, dyspareunia, polyuria, nocturia, dysuria, and urinary urgency/incontinence, which may begin before and worsen after menopause. These symptoms impact the sexual life and health-related quality of life of SjD patients. However, there are no specific recommendations for the management of vaginal dryness in this disease. Urogenital syndrome (UGS), a condition that affects women from the general population in the menopausal phase, is characterized by similar symptoms and can be treated with systemic or local hormone therapy (e.g., topical promestriene). Current data also demonstrate the efficacy and safety of vaginal fractional CO2 laser treatment for UGS. However, there are no studies on the efficacy of vaginal fractional CO2 laser and topical promestriene in the treatment of vaginal dryness in SjD.
详细描述
This is a prospective randomized study lasting 6 months. Sixty SjD patients (pre- or post-menopausal) and with complaints of vaginal dryness will be included and randomized into two groups: 30 patients for the intervention group - vaginal fractional CO2 laser - and 30 patients for the comparator group - topical promestriene. Vaginal fractional CO2 laser applications will be performed once a month for three consecutive months. Patients in the group treated with promestriene will apply a 10 mg vaginal capsule at night for fifteen consecutive days and, after this period, one application every three days, until completing six months of treatment.
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of SjD according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria (2016).
- •Controlled systemic disease activity [EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)] < 5 and without use of glucocorticoids or with a maximum dose of prednisone of 15 mg/day.
- •Present complaints of vaginal dryness upon study entry.
- •Agreeing to participate in the protocol according to the informed consent form signed before study inclusion.
排除标准
- •History of breast, uterine or ovarian neoplasia, history of thromboembolic events, heart, kidney or liver failure.
- •Other associated autoimmune rheumatic diseases, such as spondyloarthritis, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, dermatomyositis and mixed connective tissue disease.
- •Conditions that may mimic SjD, such as history of head and neck radiation therapy, acquired immunodeficiency syndrome, hepatitis B and C, sarcoidosis, IgG4-related disease, and graft-versus-host disease.
研究组 & 干预措施
SjD with sicca vagintis complaints treated with vaginal fractional CO2 laser
Thirty SjD patients with vaginitis sicca symptoms allocated to the intervention group (vaginal fractional CO2 laser)
干预措施: Fractional CO2 laser (vaginal) (Device)
SjD with sicca vagintis complaints treated with topical promestriene
Thirty SjD patients with vaginitis sicca symptoms allocated to the comparator group (topical promestriene)
干预措施: Promestriene Vaginal (Drug)
结局指标
主要结局
Vaginal Health Index (VHI)
时间窗: Four and six months
To assess the improvement in the Vaginal Health Index (VHI) after treatment compared to the patient's baseline status in both arms. This score ranges from 5 (minimum) to 25 (maximum) and higher values indicate better outcomes.
次要结局
- 6-Item version of the Female Sexual Function Index (FSFI)(Four and six months)
- Primary Sjögren's Syndrome Quality of Life questionnaire (PSSQoL)(Four and six months)
- International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)(Four and six months)
- Visual analogue scale (VAS) of vaginal dryness symptoms(Four and six months)
- Persistence of the beneficial effects of laser therapy - visual analogue scale (VAS) of vaginal dryness symptoms(Six months)
- Incidence of treatment-emergent adverse events (safety and tolerability)(One month, two months, three months, four months, five months, six months)
- EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) (safety and tolerability)(Four and six months)