TCTR20200803002已完成4 期
Efficacy of a Combined Multi-polar Radiofrequency with Pulsed Electromagnetic Field Technology for the Treatment of Vaginal Laxity: A Double-blinded, Randomized, Controlled Trial
Division of Dermatology, Ramathibodi Hospital0 个研究点目标入组 32 人开始时间: 2020年8月3日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 Years 至 45 Years（—）
- 性别
- Female
入选标准
- •Inclusion criteria consisted of self-reported of vaginal laxity defined as “very looseâ€, “moderately looseâ€, or “slightly loose†assessed by Vaginal Laxity Questionnaire (VLQ) score, normal Papanicolou smear cytology, negative pregnancy test within 2 months, willingness to participate in vaginal intercourse at least two times per month and be either surgically sterilized or willing to use an acceptable method of birth control at least one month before screening and throughout the duration of study
排除标准
- •Women were excluded from the trial if they had evidence of pelvic organ prolapse beyond the hymenal ring, an active sexually transmitted disease, urinary tract infection, those with clinically active lesion around vagina, cervix, labia majora, labia minora and clitoris, those with history of surgical vaginal repair, those taking medications known to affect collagen remodeling and healing process (eg. NSAIDS, steroid) within 1 month prior to treatment. However, those subjects who were on oral contraceptives prior to enrollment continued to take these pills throughout the study were not excluded. All pregnant and breastfeeding women, severe or uncontrolled underlying disease, unable to follow-up according to the study protocol led to exclusion of candidates.
研究者
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