Ultrasonic Evaluation of Carbon Dioxide Laser Effects on Patients With Genitourinary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Evaluating the effectiveness of Carbon Dioxide Laser in patients with genitourinary syndrome of menopause in terms of the improvement in a specific vaginal ultrasonographic parameters
研究概览
简要总结
The aim of the study was to evaluate the efficacy of vaginal Carbon Dioxide Laser treatment in patients with Genitourinary Syndrome of Menopause on the improvement of Vulvovaginal Atrophy (VVA) and stress urinary incontinence (SUI) by objective parameters and in particular to assess the ultrasound measurement of specific vaginal parameters in order to evaluate a new objective tool of assessment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age <75 years, menopause (naturally, pharmacologically or surgically induced, at least 12 months)
- •Negative Papanicolaou test (PAP) performed within 12 months before enrolment. and one of the following:
- •Presence of vulvovaginal atrophy [vaginal health index (VHI) < 15]
- •Initial Urinary Incontinence based on patient history = 1 (according to the "Stamey incontinence score of Stress Urinary Incontinence" - min. 0 = no incontinence, max. 3 = severe incontinence)
- •Standardized stress provocation test
排除标准
- •Age >45 years
- •The presence of vaginal lesions (active or in the previous 30 days).
- •genitourinary tract infection.
- •abnormal uterine bleeding.
- •use of hormone replacement therapy up to 6 months before enrolment.
- •history of photosensitivity disorder or use of photosensitizing drugs.
- •genitals prolapse (grade II - III according to the Pelvic Organ Prolapse Quantification)
- •a serious or chronic condition that could interfere with study compliance.
结局指标
主要结局
Evaluating the effectiveness of Carbon Dioxide Laser in patients with genitourinary syndrome of menopause in terms of the improvement in a specific vaginal ultrasonographic parameters
时间窗: 4 months
To evaluate the primary outcome, we examined the following vaginal ultrasonographic parameters (by transvaginal probe), both before and after 3 vaginal Carbon Dioxide Laser applications: * Thickness of the anterior vaginal walls (VWT) at the level of the introitus of the inferior vaginal third (expressed in millimeters); * Thickness of the posterior VWT at the level of the introitus of the inferior vaginal third (expressed in millimeters). Positive outcomes are evidenced if thickness (expressed in millimeters) is increased after treatment in both anterior and posterior vaginal walls.
次要结局
未报告次要终点
研究者
VILLA PAOLA
Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS