Randomized, Controlled Trial to Evaluate the Efficacy of Non-ablative Radiofrequency Combined With Pelvic Floor Muscle Training on Symptoms of Genitourinary Syndrome of Menopause in Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Subjective sensation of vaginal dryness
研究概览
简要总结
The goal of this clinical trial is to find out whether non-ablative radiofrequency (RF) applied together with pelvic-floor muscle exercises can ease vaginal dryness and other symptoms of genitourinary syndrome of menopause (GSM) in women aged 18-75 years who have survived breast cancer and currently experience those symptoms.
The main questions it aims to answer are:
Does the combination of RF + exercise lower the 0-to-10 vaginal-dryness score more than sham (inactive) RF + exercise at 6 weeks (end of treatment) and 3 months?
What other changes (pain during intercourse, Vaginal Health Index, urinary and sexual function, pelvic-floor strength, overall satisfaction) are seen in each group?
Researchers will compare six sessions of active RF with six sessions of sham (inactive) RF to see whether the active treatment works better.
Participants will:
Visit the hospital once a week for 6 weeks. Each visit includes about 20 minutes of intra-/extra-vaginal RF (or sham) and 20 minutes of guided pelvic-floor training whose content is adapted and progressed throughout the study.
Carry out a structured, progressive home-exercise programme, recording any discomfort in a diary.
Complete questionnaires and tests at baseline, after session 6, and 3 months later.
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 and outcome assessors will be blinded to group allocation. In addition, the independent statistician responsible for data analysis will remain blinded until the database is locked. Only the treating physiotherapists and the study coordinator will have access to the randomization list
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who are breast cancer survivors and clinically confirmed to be disease-free by their physician.
- •Amenorrhea for more than 12 months and vaginal pH ≥ 5, with symptoms related to genitourinary syndrome of menopause (GSM), as diagnosed by a physician. Symptoms must be bothersome and not better explained by another clinical condition.
- •Negative urine culture at baseline.
- •Moderate to severe vaginal dryness, defined as a score > 4 on the Numeric Rating Scale (NRS 0-10)
排除标准
- •Age over 75 years.
- •Current or past diagnosis of any cancer other than breast cancer.
- •Pelvic surgery, chemotherapy, or radiotherapy in the past 3 months.
- •Use of local estrogen therapy within the past month.
- •Active genital infections.
- •Diagnosis of HIV infection or severe immunosuppression.
- •Presence of pacemakers, metallic implants, or electromagnetic devices.
- •Coagulation disorders or current use of anticoagulants.
- •Pelvic organ prolapse stage > III (POP-Q classification).
- •Unexplained abnormal vaginal bleeding.
- •History of pelvic anti-incontinence surgery, with or without mesh.
- •Inflammatory dermatoses of the vulva.
- •Pelvic-floor muscle strength score of 0/5 on the Modified Oxford Scale.
- •Nickel allergy.
- •Previous treatment with radiofrequency in the pelvic or genital area.
研究组 & 干预措施
Active Non-ablative Radiofrequency + Pelvic-Floor Muscle Training
Participants in this group will receive non-ablative monopolar capacitive radiofrequency therapy combined with pelvic-floor muscle training guided by biofeedback.
干预措施: Active Radiofrequency (Capenergy C500 UpGradeC200) (Device)
Sham Radiofrequency + Pelvic-Floor Muscle Training
Participants in this group will receive sham radiofrequency treatment combined with pelvic-floor muscle training guided by biofeedback.
干预措施: Sham Radiofrequency (Capenergy C500 UpGrade C200 - Placebo Mode) (Device)
结局指标
主要结局
Subjective sensation of vaginal dryness
时间窗: T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1)
Measured using a 0-10 Numeric Rating Scale (NRS), where 0 indicates "no dryness" and 10 indicates "maximum dryness". The NRS is a self-reported, single-item scale commonly used for subjective symptom intensity.
次要结局
- Subjective sensation of pain during sexual activity (NRS 0-10)(T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1))
- Subjective sensation of vaginal itching (NRS 0-10)(T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1))
- Vaginal Health Index Score(T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1))
- Female Sexual Function Index total score(T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1))
- Vaginal pH level(T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1))
- Pelvic organ support parameters measured by POP-Q system(T0 (baseline, before intervention); T2 (3 months after T1))
- International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF total score)(T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1))
- ICIQ-FLUTS(T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1))
- Pelvic-floor muscle strength (Modified Oxford Scale, 0-5)(T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1))
- Pelvic-floor muscle activity measured by surface electromyography (μV)(T0 (baseline, before intervention); T1 (immediately after completing the intervention); T2 (3 months after T1))
- Subjective global impression of improvement (7-point Likert scale)(T1 (immediately after completing the intervention); T2 (3 months after T1))
- Incidence of adverse events related to the intervention(T1 (immediately after completing the intervention); T2 (3 months after T1))
- Adherence to prescribed home pelvic-floor training(T1 (immediately after completing the intervention); T2 (3 months after T1))
- Local recurrence of breast cancer at 12 months(12 months after T1)
- Participant's belief regarding group allocation (intervention vs. placebo)(T1 (immediately after completing the intervention))
研究者
Irene Lázaro Navas
PhD Physiotherapist, Department of Rehabilitation Medicine, Hospital Universitario Ramón y Cajal
Hospital Universitario Ramon y Cajal