Efficacy of Non-Ablative Radiofrequency on Vaginal and Sexual Health in Postmenopausal Women: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Change in Female Sexual Function Index (FSFI)
研究概览
简要总结
This study will test if non-ablative monopolar radiofrequency can help improve vaginal tissue and reduce symptoms of Genitourinary Syndrome of Menopause (GSM) in postmenopausal women. The study is a randomized, sham-controlled clinical trial in which participants and outcome assessors were masked to treatment allocation. The study will examine the impact of the treatment on sexual function, vaginal health, and quality of life over an extended period. There will be two groups in the study: one will receive the non-ablative monopolar radiofrequency treatment, and the other will receive the placebo treatment. Participants will have six treatment sessions and will be checked at the start, end, and three months post-treatment.
详细描述
The purpose of this study is to evaluate the efficacy of non-ablative monopolar radiofrequency (RF) treatment in improving vaginal tissue regeneration and alleviating symptoms of Genitourinary Syndrome of Menopause (GSM) in postmenopausal women. This randomized clinical trial will include two groups: one receiving the active RF treatment and the other receiving a placebo treatment. The study will include six treatment sessions for each participant, with evaluations conducted at baseline, at the end of the treatment period, and three months post-treatment.
The sample size was calculated to detect a between-group difference of 4.5 points in the total FSFI score, with a two-sided α of 0.05, 80% power, and an assumed standard deviation of 6. Allowing for an anticipated 10% attrition rate, 31 participants per group were required (total N = 62).
Participants will be postmenopausal women who have experienced more than one year of amenorrhea and exhibit symptoms of GSM, such as vaginal dryness, irritation, and sexual dysfunction.
The primary outcome measures will include improvements in vaginal health assessed through clinical examination and patient-reported outcomes related to sexual function.
Secondary outcome measures will involve the analysis of vaginal pH, the maturation index of vaginal epithelial cells, and any adverse events reported during the study. The intervention involves the use of a non-ablative monopolar RF device applied intracavitarily. The placebo group will undergo the same procedure without the active RF component.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants were not informed of treatment allocation. The treating physiotherapist could not be masked because delivery of the intervention required activation or withholding of radiofrequency energy. Outcome assessors were blinded to group allocation, and the data analyst remained blinded until database lock. Because active radiofrequency produced a thermal sensation, participant masking may have been compromised; masking success was not formally assessed.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and 65 years.
- •Postmenopausal women (defined as no menstrual period for at least 12 months).
- •Experiencing symptoms of Genitourinary Syndrome of Menopause (GSM), such as vaginal dryness, irritation, or discomfort.
- •Experiencing discomfort or complaints during vaginal penetration. Engaging in sexual activity (at least once a month).
- •Willing to participate in the study and sign the informed consent form.
排除标准
- •Presenting with active vaginal infections.
- •Presence of neurological, neoplastic, or sexually transmitted diseases.
- •Presenting with vulvodynia or vaginismus.
- •Prolapse grade 2 or higher.
- •Presenting with altered sensitivity in the pelvic area.
- •Being a pacemaker carrier or having any device that contains batteries.
- •Hormonal treatment with estrogens in the last 3 months.
- •History of radiotherapy in the pelvic area.
- •Recent pelvic surgery (within the last 6 months).
- •Being on anticoagulant treatment.
- •Having undergone laser treatment in the pelvic area or ablative vaginal rejuvenation in the last 6 months.
- •Cognitive impairment that prevents answering the questionnaires.
研究组 & 干预措施
Treatment Group
6 treatment sessions of non-ablative radiofrequency, with a frequency of 1 session per week. The following protocol will be followed: Preparation (5 minutes): Resistive monopolar electrode applied to vulvar area with gradual heating (sensation 4-5/10).
Main Phase (10 minutes): Intracavitary capacitive electrode used to reach and maintain 41-43°C throughout the 10-minute application.
Final Phase (5 minutes): Repeat resistive electrode application with subthermal effect (sensation 3-4/10).
干预措施: Non-ablative monopolar radiofrequency treatment (Device)
Placebo Group
Participants in this group will receive the same treatment protocol, but without the application of heat.
干预措施: Non-ablative monopolar radiofrequency treatment (Device)
结局指标
主要结局
Change in Female Sexual Function Index (FSFI)
时间窗: Baseline, end of treatment period (6 weeks), and three months post-treatment.
Multidimensional questionnaire evaluates sexual function over the past 4 weeks. The total score ranges from 2.0 (severe dysfunction) to 36.0 (no dysfunction). Sexual dysfunction was defined as a score equal to or below 26.55
Change in Vaginal Health Index (VHI)
时间窗: Baseline, end of treatment period (6 weeks), and three months post-treatment.
A tool that evaluates five parameters: vaginal elasticity, vaginal secretion (type and consistency), pH, mucosal epithelial integrity, and vaginal moisture. Each parameter was scored on a scale from 1 (most unfavorable condition) to 5 (optimal condition), with a maximum possible score of 25 points. In cases where the score was below 15, the vagina was considered atrophic.
次要结局
- Change in sexual pain(Baseline, end of treatment period (6 weeks), and three months post-treatment.)
- Change in Vaginal secretion(Baseline, end of treatment period (6 weeks), and three months post-treatment.)
- Change in vaginal pH(Baseline, end of treatment period (6 weeks), and three months post-treatment.)
- Change in sexual satisfaction(Baseline, end of treatment period (6 weeks), and three months post-treatment.)
- Change in sexual arousal(Baseline, end of treatment period (6 weeks), and three months post-treatment.)
- Change in sexual desire(Baseline, end of treatment period (6 weeks), and three months post-treatment.)
- Change in sexual lubrication(Baseline, end of treatment period (6 weeks), and three months post-treatment.)
- Change in sexual orgasm(Baseline, end of treatment period (6 weeks), and three months post-treatment.)
- Change in vaginal Elasticity(Baseline, end of treatment period (6 weeks), and three months post-treatment.)
- Change in vaginal Ephitelial integrity(Baseline, end of treatment period (6 weeks), and three months post-treatment.)
- Change in vaginal Moisture(Baseline, end of treatment period (6 weeks), and three months post-treatment.)
- Change in Vaginal Maturity Index(Baseline, end of treatment period (6 weeks), and three months post-treatment.)
- Change in Status Estrogen(Baseline, end of treatment period (6 weeks), and three months post-treatment.)
- Change in Vaginal Laxity Questionnaire (VLQ)(Baseline, end of treatment period (6 weeks), and three months post-treatment.)
- Change in Pain assessed by NRS(Baseline, end of treatment period (6 weeks), and three months post-treatment.)
- Change in Urinary Symptoms by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form(Baseline, end of treatment period (5 weeks), and three months post-treatment.)
- Change in Health- related quality of Life by SF-12(Baseline, end of treatment period (6 weeks), and three months post-treatment.)