The Application of External Fractional CO2 Laser Energy Versus Topical Lidocaine for the Treatment of Vestibulodynia in Premenopausal Women on Hormonal Contraception: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- VAS
研究概览
简要总结
CO2 laser energy is currently used widely for the treatment of postmenopausal women who have vaginal atrophy due to the lack of estrogen. However, its effect on premenopausal women with hormonally-mediated vulvar vestibulodynia is unknown. This study seeks to evaluate the effect of CO2 laser on young women and compare it to topical lidocaine.
详细描述
The purpose of this study is to see if vaginal laser therapy with MonaLisa Touch® will be more effective in treating vestibulodynia than current treatment with a topical lidocaine ointment. Vestibulodynia is a common bothersome condition and is more likely to occur in women on hormonal contraceptive treatment. To date, there are no effective treatments that address the underlying causes of the disease. MonaLisa Touch® is a laser procedure that delivers CO2 laser energy to the vaginal wall tissue. This energy causes the patient's own body to regenerate collagen and blood vessels, changing the tissue to make it healthier. The MonaLisa Touch® technology may help vestibulodynia by potentially fixing the underlying cause. This may be more effective than using the topical lidocaine which makes the tissue numb.
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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 years to 40 years
- •Hormonal contraceptive therapy for at least one year consecutive duration
- •Vestibulodynia diagnosis meeting the following criteria:
- •Localized vulvar pain to vaginal vestibule
- •At least 3 months duration
- •Without clear identifiable cause
排除标准
- •Suspected primary cause to vestibular pain that warrants directed treatment
- •History of chronic infection or autoimmune disease
- •Prior pelvic surgery including mesh placement for incontinence or prolapse, vestibulectomy, vulvectomy, or labiaplasty
- •Active vulvar or vaginal infection
- •Allergy or contraindication to topical lidocaine treatment
- •Prior diagnosis or treatment of vulvar intraepithelial neoplasia or vulvar malignancy
研究组 & 干预措施
Lidocaine
5% topical lidocaine will be applied nightly via a cotton square in participants
干预措施: Lidocaine patch 5% (Drug)
CO2 laser
Mona Lisa CO2 laser will be applied externally to the vulvar vestibule in three sessions over a three month period.
干预措施: CO2 laser (Device)
结局指标
主要结局
VAS
时间窗: 3 months
visual analog pain scale to q-tip palpation
次要结局
- PFDI(3 months)
研究者
Michael Ingber
Director of The Center for Specialized Women's Health, division of Garden State Urology/Atlantic Health System
Atlantic Health System