NCT04227392已完成不适用
Effect of Vaginal Radiofrequency Therapy on Vaginal Laxity : Pilot Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- change of vaginal laxity score from baseline
研究概览
简要总结
To examine the efficacy and safety of radiofrequency therapy on vaginal laxity, The investigators enrolled 30 women with vaginal laxity. Radiofrequency therapy was consisted of 2 sessions with 3 week interval. A session included 20 minutes radiofrequency therapy on vaginal mucosa. Vaginal laxity score, female sexual function index (FSFI), female sexual distress scale (FSDS), vaginal pressure, adverse events were examined. Follow up period is 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •vaginal laxity score >= 3
- •negative pregnancy test within 2 months
排除标准
- •genital anomaly
- •pelvic prolapse stage >= stage 3
- •active genital infection
- •vulvar pain or deformity
- •disease related to sexual behavior
- •current, chronic NSAIDs intake
- •any acute illness
- •cognitive disorder
- •pacemaker insertion
- •metal implants
研究组 & 干预措施
Experimental
Experimental
women who undergo radiofrequency therapy
干预措施: vaginal radiofrequency (Device)
结局指标
主要结局
change of vaginal laxity score from baseline
时间窗: baseline - at 2nd therapy session (3week from baseline) - 1 month from 2nd therapy session - 3 month from 2nd therapy session
subjective vaginal laxity
次要结局
- change of vaginal pressure from baseline(baseline - at 2nd therapy session (3week from baseline) - 1 month from 2nd therapy session - 3 month from 2nd therapy session)
- change of FSFI score from baseline(baseline - 1 month from 2nd therapy session - 3 month from 2nd therapy session)
- change of FSDS score from baseline(baseline - 1 month from 2nd therapy session - 3 month from 2nd therapy session)
研究者
研究点 (1)
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