NCT04227392已完成不适用
Effect of Vaginal Radiofrequency Therapy on Vaginal Laxity : Pilot Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 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
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 (2)
Loading locations...
相似试验
尚未招募
不适用
A Study of the Use of Vaginal Radiofrequency Therapy in Treatment of SUI.Urinary Incontinence, StressNCT05570071Qianfoshan Hospital90
已完成
不适用
The Effectiveness of Transvaginal Radiofrequency in Women With Stress Urinary IncontinenceUrinary Incontinence,StressPelvic Floor DisordersUrinary IncontinencePelvic Floor Muscle WeaknessNCT05702567José Casaña Granell42
招募中
不适用
Effects of Non-ablative Radiofrequency on Female Genito-pelvic Pain DisorderPelvic PainNCT06303609Centro de Atenção ao Assoalho Pélvico56
已完成
不适用
Transvaginal Radiofrequency Ablation for Overactive BladderOveractive BladderNCT06458556InMode MD Ltd.17
已完成
2 期
Radiofrequency Female External Genital Region: a Clinical TrialDissatisfaction Appearance of the External GenitaliaNCT02611791Centro de Atenção ao Assoalho Pélvico42