A Randomized Controlled Trial Comparing Fractional Bipolar Radiofrequency Therapy VS Sham for Treatment of Vaginal Laxity in Premenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- The Vaginal Laxity Questionnaire (VLQ)
研究概览
简要总结
Knowledge gap: Lack of randomized controlled trials evaluating the efficacy of fractional bipolar radiofrequency therapy compared to a sham treatment for vaginal laxity in premenopausal women.
Primary outcomes
-
Subjective outcomes: The Vaginal Laxity Questionnaire (VLQ) Secondary outcomes
-
Subjective outcomes
-
The Thai version of the Female Sexual Function Index (FSFI) will be administered to evaluate sexual function.
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The Thai version of the Female Genital Self-Image Scale (FGSIS)
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The International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS), validated in Thai
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The Patient Global Impression of Improvement (PGI-I)
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Patients will report any side effects or adverse events experienced during the study.
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Objective outcomes - Vaginal wall thickness will be assessed using 3D transvaginal ultrasound imaging, following the standardized protocol established in previous studies.
PICO:
P (Population): Premenopausal women with clinically diagnosed vaginal laxity who are sexually active.
I (Intervention): Fractional bipolar radiofrequency therapy (single treatment)
C (Comparison): Sham treatment (placebo).
O (Outcomes):
- Primary Outcome: Improvement in vaginal laxity as assessed by the Vaginal Laxity Questionnaire (VLQ).
- Secondary Outcomes: Patient satisfaction with treatment (measured by the Patient Global Impression of Improvement - PGI-I)., Changes in sexual function (assessed using the Thai version of the Female Sexual Function Index - FSFI).
Perception of genital self-image (evaluated using the Thai version of the Female Genital Self-Image Scale - FGSIS)., Evaluation of vaginal symptoms (using the International Consultation on Incontinence Questionnaire-Vaginal Symptoms - ICIQ-VS), Objective assessment of vaginal wall thickness through 3D transvaginal ultrasound, Recording of any side effects or adverse events associated with the treatment.
Study Design:
A double-blind, randomized controlled trial (RCT) conducted at the Female Pelvic Medicine and Reconstructive Surgery clinic in Ramathibodi Hospital.
详细描述
Vaginal laxity is a prevalent concern among premenopausal women today. A retrospective cohort study found that 24% of women reported experiencing vaginal laxity. According to the IUGA/ICS 2018 definition, vaginal laxity is characterized by a sensation of looseness in the vagina.
Fractional bipolar radiofrequency therapy has emerged as a promising minimally invasive treatment modality. This non-ablative approach uses fractional RF technology with microneedles to deliver thermal injury to the subdermis, stimulating collagen production, promoting tissue remodeling and improving tissue tightening, potentially addressing symptoms associated with vaginal laxity. Recent advancements in RF technology have led to its increasing use in aesthetic and gynecological applications. Evidence suggests that RF microneedling effectively remodels subdermal fat and improves skin firmness. However, no previous study has been conducted on the treatment of vaginal laxity using fractional bipolar radiofrequency (with microneedling), highlighting the need for rigorous scientific evaluation to provide conclusive evidence on its effectiveness, including improvements in sexual function and safety.
Additionally, the use of 3D transvaginal ultrasound to measure vaginal wall thickness is still limited in clinical studies. It is necessary to investigate whether fractional bipolar radiofrequency can improve vaginal wall thickness and explore the association between vaginal wall thickness and the clinical presentation of vaginal laxity in patients.
This study aims to address this gap by conducting a first randomized controlled trial to compare the efficacy of fractional bipolar radiofrequency therapy with a sham treatment in premenopausal women. By employing a methodological approach, this research seeks to contribute valuable insights into the clinical benefits of fractional bipolar radiofrequency therapy, ultimately guiding future treatment strategies for vaginal laxity.
Primary Objective:
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
This study employs a double-blind design to minimize bias by blinding both the patients and evaluators. All patients, regardless of group, will remain blinded. The sham group will receive treatment with a specialized sham device that mimics the treatment group's equipment. There are no differences in the design of the tip device, the auditory signal (beeping), or the pulse count display. The physician managing the allocation, will not be involved in the treatment procedures or the assessment process. Subjective outcomes, such as questionnaires (VLQ, FSFI, FGSIS, ICIG-VS, PGI-I), will be assessed by a research assistant from the urogynecology clinic who is blinded to the group assignments, ensuring she is unaware of which patients received the actual treatment and which received the sham.
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women
- •Age 20-55 years
- •Reported symptoms of vaginal looseness with a score of at least 1 on The Vaginal Laxity Questionnaire (VLQ)
- •Sexually active (≥1 time/month)
- •Willing to undergo vaginal energy-based treatment and attend follow-up visits 3 months after treatment
排除标准
- •- Presence of sexually transmitted diseases or active genital lesions
- •Currently pregnant or planning for conception during study period
- •Pelvic organ prolapse (POP ≥ Stage II)
- •Previous treatment for vaginal laxity with modalities other than pelvic floor muscle training
- •Currently using intrauterine devices for contraception
- •Presence of any active electrical implant such as pacemaker, internal defibrillator
- •Current condition of genital cancer
研究组 & 干预措施
Intervention (fractional bipolar radiofrequency therapy)
A single treatment with intravaginal device for fractional bipolar radiofrequency therapy. Using the EmpowerRF platform with the Morpheus8V applicator, RF energy was applied via 24 microneedles, to release the radiofrequency energy to the vaginal mucosa
干预措施: Fractional bipolar radiofrequency (Device)
Sham group
The sham group will receive treatment with a specialized sham device that mimics the treatment group's equipment. There are no differences in the design of the tip device, the auditory signal (beeping), or the pulse count display.
干预措施: Sham device (Device)
结局指标
主要结局
The Vaginal Laxity Questionnaire (VLQ)
时间窗: From enrollment to the end of treatment at 12 weeks
Subjective outcomes * The Vaginal Laxity Questionnaire (VLQ) will be used to assess patient-reported vaginal laxity. * A score of 1-3 indicates positive for vaginal laxity (1 = severe, 2 = moderate, 3 = mild symptom). * A score of 4-7 indicates no vaginal laxity, with 7 representing the greatest vaginal tightness. * A higher VLQ score post-treatment reflects improvement in vaginal laxity.
次要结局
- Subjective outcomes: The Patient Global Impression of Improvement (PGI-I)(From 4-week post-treatment to the end of the 12-week treatment period)
- Subjective outcome: Patient-reported adverse events(From post-treatment to the end of the 12-week treatment period)
- Subjective outcome: The Thai version of the Female Sexual Function Index (FSFI)(From enrollment to the end of treatment at 12 weeks)
- Subjective outcome: The Thai version of the Female Genital Self-Image Scale (FGSIS)(From enrollment to the end of treatment at 12 weeks)
- Subjective outcome: The International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS)(From enrollment to the end of treatment at 12 weeks)
- Objective outcomes: the difference of vaginal wall thickness before and after intervention(From enrollment to the end of treatment at 12 weeks)