Clitoral Sensitivity Enhancement With Hyperstacking of Er:YAG SMOOTH Mode
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 试验地点
- 2
- 主要终点
- Change of bothersome symptoms (decreased intensity of clitoral/vaginal response, decreased time of good sexual response, decreased orgasm sensation)
研究概览
简要总结
The purpose of this clinical trial is to evaluate whether non-ablative Er:YAG laser treatment can improve decreased clitoral sensitivity in adult women who report this concern. Effectiveness and safety will be assessed after each laser session and again at a 2-month follow-up visit.
详细描述
This study is designed to investigate whether non-ablative Er:YAG laser treatment can improve clitoral sensitivity in adult women who report decreased sensitivity. Reduced clitoral sensitivity can negatively impact sexual response, orgasm, and quality of life, yet effective treatment options are limited.
The primary goal of this clinical trial is to determine the effectiveness and safety of non-ablative Er:YAG laser treatment for women experiencing decreased clitoral sensitivity. Specifically, the study aims to assess:
The degree to which laser treatment enhances vaginal and clitoral sexual response, the time required to achieve noticeable improvements in sexual response, the impact of treatment on orgasmic function and patient satisfaction with the treatment process and outcomes.
Participants will undergo three laser treatment sessions, with evaluations conducted at a 2-month follow-up. Both effectiveness (improvements in sexual response and satisfaction) and safety outcomes will be carefully monitored.
By exploring this minimally-invasive therapeutic option, the study seeks to provide new insights into the management of decreased clitoral sensitivity and to help identify safe and effective approaches for improving sexual health in women.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •above 18 years
- •sexually active at least once per month
排除标准
- •anorgasmia
- •pregnancy
- •urinary tract infections
- •genital infectious diseases of other etiology (HPV, molluscum contagiosum, syphilis, HIV, etc.)
- •genital bleeding
- •collagenopathies
- •ongoing chemotherapy
- •active genital cancer
- •patients undergoing pelvic radiotherapy
- •any genital or extragenital pathology that may interfere with treatment
- •patients who have limitations in performing a follow-up to this study
- •patients with psychiatric disorders that may be difficult to treat
- •patients who have a contraindication to vaginal laser treatments
研究组 & 干预措施
Active therapy with non-ablative Er:YAG laser
Patients underwent three laser sessions with non-ablative SMOOTH Er:YAG laser, with 20 days interval between sessions
干预措施: Active therapy with non-ablative Er:YAG laser (Device)
结局指标
主要结局
Change of bothersome symptoms (decreased intensity of clitoral/vaginal response, decreased time of good sexual response, decreased orgasm sensation)
时间窗: Change from Baseline at 2 months after last intervention
Evaluation of clitoral sensitivity change was performed 2 months after the last treatment session. Patients answered a five-point Likert scale (from 0 to 4) questionnaire.
次要结局
- Patient satisfaction with 5-point Likert scale(Each visit included recording of any adverse effect. Patients were instructed to report and adverse effect that may have occured during the whole duration of the study.)
- Recording of frequency and severity of adverse effects related to laser treatment(From Baseline to 2 months after last intervention)
- Patient satisfaction with 5-point Likert scale(Each visit included recording of any adverse effect. Patients were instructed to report and adverse effect that may have occured during the whole duration of the study.)
- Recording of frequency and severity of adverse effects related to laser treatment(From Baseline to 2 months after last intervention)
研究者
Adrian Gaspar
Principal Investigator
Espacio Gaspar Clinic