Efficacy of Bipolar Radiofrequency for Genitourinary Syndrome of Menopause in Postmenopausal Women: A Randomized, Sham-Controlled Clinical Trial
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- University of Castilla-La Mancha
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Sexual Function (FSFI Total Score)
概览
简要总结
This randomized, sham-controlled clinical trial aims to evaluate the efficacy and safety of bipolar radiofrequency in the treatment of genitourinary syndrome of menopause (GSM) in postmenopausal women. Participants will be randomly assigned to receive either active bipolar radiofrequency treatment or a sham procedure.
The primary objective is to determine whether bipolar radiofrequency improves vaginal and sexual function. Secondary objectives include assessment of pain with vaginal penetration, vaginal lubrication and tissue distensibility, patient-reported vulvovaginal symptom severity, and treatment safety and tolerability.
详细描述
Genitourinary syndrome of menopause (GSM) is a chronic condition related to hypoestrogenism that commonly results in vulvovaginal dryness, burning, irritation, dyspareunia, and urinary symptoms, with meaningful impact on vaginal and sexual function and overall quality of life. While hormonal therapies are effective for many patients, non-hormonal treatment alternatives are needed for women who prefer to avoid hormones or have contraindications.
Bipolar radiofrequency is a non-ablative energy-based modality intended to promote tissue remodeling and improve vaginal mucosal and connective tissue characteristics. This study is designed to generate rigorous evidence regarding the clinical efficacy and safety of bipolar radiofrequency for GSM.
This study is a randomized, parallel-group, sham-controlled clinical trial designed to evaluate the efficacy and safety of bipolar radiofrequency in postmenopausal women with GSM. Participants will be randomly assigned to receive either active bipolar radiofrequency treatment or a sham procedure.
The co-primary outcomes are sexual function, assessed using the Female Sexual Function Index (FSFI), and vaginal health, assessed using the Vaginal Health Index (VHI). Outcomes will be evaluated at baseline, immediately post-treatment, and three months after completion of treatment.
Secondary outcomes include pain with vaginal penetration, vaginal lubrication and tissue distensibility, vulvovaginal symptom severity scores, and treatment safety and tolerability.
In addition to statistical significance, the study will assess clinical relevance by examining whether observed improvements meet or exceed thresholds for clinically meaningful change (minimal clinically important difference and clinical relevance of the treatment) where established, to support interpretation of treatment benefit.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be masked to group assignment. Due to the thermal sensation associated with active bipolar radiofrequency and the absence of heat during sham, participants and treating operators will not be masked.
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
- •Women aged 40 to 65 years
- •Postmenopausal status
- •Presence of at least one symptom of genitourinary syndrome of menopause (e.g., vaginal dryness, irritation, pruritus, urinary symptoms, or dyspareunia)
- •Sexual activity at least once per month
- •Ability to understand and complete study questionnaires
- •Provision of written informed consent
排除标准
- •Active vaginal infection
- •Neurological, neoplastic, or sexually transmitted diseases
- •Diagnosis of vulvodynia or vaginismus
- •Pelvic organ prolapse stage II or higher
- •Pelviperineal hypoesthesia
- •Presence of pacemaker or other electronic implantable devices
- •Use of estrogen hormonal therapy within the previous 3 months
- •History of pelvic radiotherapy
- •Pelvic surgery within the previous 6 months
- •Active anticoagulant therapy
研究组 & 干预措施
Active Bipolar Radiofrequency
Participants assigned to the active intervention group will receive six weekly sessions of bipolar radiofrequency therapy delivered according to a standardized protocol including external and intracavitary application.
干预措施: Active bipolar radiofrequency therapy (Device)
Sham Procedure
Participants assigned to the sham comparator group will undergo six weekly sessions replicating the structure and duration of the active protocol but without delivery of therapeutic radiofrequency energy.
干预措施: Sham radiofrequency procedure (Device)
结局指标
主要结局
Change in Sexual Function (FSFI Total Score)
时间窗: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
Sexual function will be assessed using the Female Sexual Function Index (FSFI). The primary endpoints are the changes in total FSFI score from baseline to immediately post-treatment and from baseline to 3 months post-treatment to evaluate both immediate effect and durability.
Change in Vaginal Health (Vaginal Health Index Total Score)
时间窗: Baseline, 1 week after completion of treatment, and 3 months after completion of treatment
Vaginal health will be assessed using the Vaginal Health Index (VHI). The primary endpoints are the changes in total VHI score from baseline to immediately post-treatment and from baseline to 3 months post-treatment to evaluate both immediate effect and durability.
次要结局
- Change in Female Sexual Function Index Domain Scores(Baseline, 1 week after completion of treatment, and 3 months after completion of treatment)
- Change in Vaginal Health Index Component Scores(Baseline, 1 week after completion of treatment, and 3 months after completion of treatment)
- Change in the pain during vaginal penetration/distension(Baseline, 1 week after completion of treatment, and 3 months after completion of treatment)
- Change in Vaginal Distensibility Threshold (Phenix Pelvimeter)(Baseline, immediately post-treatment, and 3 months post-treatment)
- Change in Patient-Reported Vulvovaginal and Urinary Symptom Severity (0-10 NRS)(Baseline, 1 week after completion of treatment, and 3 months post-treatment)
- Change in Female Sexual Distress (FSDS-R)(Baseline, 1 week after completion of treatment, and 3 months after completion of treatment)
- Change in Day-to-Day Impact of Vaginal Aging (DIVA Questionnaire)(Baseline, 1 week after completion of treatment, and 3 months after completion of treatment)
- Change in Health-Related Quality of Life(Baseline, 1 week after completion of treatment, and 3 months after completion of treatment)
- Proportion of Participants Achieving Clinically Meaningful Improvement (Anchor-Based)(Baseline, 1 week after completion of treatment, and 3 months after completion of treatment)
- Treatment Satisfaction(Baseline, 1 week after completion of treatment, and 3 months after completion of treatment)
- Incidence of Adverse Events(From first session through 3 months post-treatment)