Genitourinary Syndrome of Menopause Induced by Breast Cancer Treatments: A Randomized Clinical Trial Protocol Comparing Multimodal Pelvic Floor Physiotherapy and Frac-tional CO2 Laser Therapy (PILME Study).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 182
- 试验地点
- 2
- 主要终点
- Female Sexual Function (FSFI)
研究概览
简要总结
This randomized, single-blind clinical trial will compare the effectiveness of multimodal pelvic floor physiotherapy (PPT) and fractional CO2 vaginal laser therapy in reducing genitourinary syndrome of menopause (GSM) symptoms among breast cancer (BC) survivors. GSM, induced by cancer treatments, is common in BC survivors due to hormonal deprivation, and effective non-hormonal treatments are needed. The study will enroll 210 women diagnosed with GSM following BC treatment, who will be randomly assigned to either three sessions of CO2 vaginal laser therapy or eight sessions of multimodal PPT, which includes pelvic floor muscle training, vaginal non-ablative radiofrequency, education, and moisturizers. Primary outcomes will include perineal pain, sexual function, and health-related quality of life (HRQoL), with assessments at baseline, post-intervention, and at 3, 6, and 12 months. The hypothesis is that multimodal PPT will lead to greater improvements in pelvic pain, muscle function, and sexual health, with sustained benefits over time. This trial aims to provide evidence for non-invasive, non-hormonal treatments to manage GSM in BC survivors, filling a significant therapeutic gap.
详细描述
Background: Genitourinary syndrome of menopause (GSM) induced by breast cancer (BC) treatments is highly prevalent among BC survivors due to the abrupt hor-monal deprivation caused by oncological therapies. Given the contraindication of hor-monal treatments in this population, there is a critical need for effective non-hormonal alternatives to alleviate GSM symptoms.
Objectives: This study aims to compare the effectiveness of multimodal pelvic floor physiotherapy (PPT)-comprising pelvic floor muscle training, vaginal non-ablative radiofrequency, pelvic health education, and vaginal moisturizers-against fractional CO2 vaginal laser therapy in reducing GSM symptoms among BC survivors.
Methods: A randomized, single-blind clinical trial will be conducted with 210 women diagnosed with GSM after undergoing BC treatment. Participants will be ran-domly assigned (1:1) to receive either three sessions of CO2 vaginal laser therapy or eight face-to-face sessions of multimodal PPT. Assessments will be performed at base-line, immediately after the intervention, and at 3-, 6-, and 12- months post-intervention. Primary outcomes will include perineal pain, sexual function, and health-related quality of life (HRQoL). Additionally, a cost-effectiveness analysis will be conducted to evaluate the costs of each intervention relative to the changes in clinical outcomes, and any ad-verse effects will be monitored throughout the study.
Results: It is hypothesized that women undergoing multimodal PPT will show greater reductions in pelvic pain and improvements in pelvic floor muscle strength, endurance, and relaxation compared to those receiving CO2 laser therapy, alongside enhanced sexual function and HRQoL. These improvements are expected to be sus-tained in the short and medium term through continued adherence to home exercises and educational strategies.
Conclusions: This study aims to provide evidence for novel, non-invasive, and non-hormonal treatment strategies to manage GSM in BC survivors, addressing an important gap in the therapeutic landscape for this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 38 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer survivors diagnosed with GSM as a result of cancer treatment
- •Vaginal Health Index (VHI) score of ≤ 15.
排除标准
- •History of conservative treatment or surgery for pelvic floor dysfunction or GSM
- •Currently undergoing chemotherapy, or have undergone BC surgery but have not received chemotherapy or hormonal treatment.
- •Presence of concomitant or systemic diseases that could interfere with the proposed treatments, such as a recurrence of the oncological process, active or recurrent untreated urinary tract infections, hematuria, or cognitive impairments that hinder the participant's ability to comprehend study information, respond to questionnaires, provide informed consent, or fully participate in the study.
结局指标
主要结局
Female Sexual Function (FSFI)
时间窗: Baseline (before intervention) (A0); immediately after completing the intervention (A1), and at 3 months (A2), 6 months (A3), and 12 months (A4) following A1.
The FSFI is a 19-item questionnaire that evaluates sexual function across six domains: de-sire, arousal, lubrication, orgasm, satisfaction, and pain. Each domain is scored from 0 to 5, with higher scores indicating better sexual function. The total FSFI score ranges from 2 to 36, with higher scores reflecting improved sexual function.
Subjective Pelvic Perineal Pain Intensity
时间窗: Baseline (before intervention) (A0); immediately after completing the intervention (A1), and at 3 months (A2), 6 months (A3), and 12 months (A4) following A1.
Measured using a 100-mm horizontal Visual Analog Scale (VAS), with "no pain" on the left and "worst imaginable pain" on the right.
Health-Related Quality of Life (HRQoL)
时间窗: Baseline (before intervention) (A0); immediately after completing the intervention (A1), and at 3 months (A2), 6 months (A3), and 12 months (A4) following A1.
This 40-item questionnaire evaluates HRQoL across four general domains (physical, emo-tional, social, and functional well-being), along with two specific subscales: breast cancer (9 items) and arm symptoms (4 items). The scores for the BC subscale (BCS) and arm subscale range from 0 to 56. The Trial Outcome Index (TOI), a key measure, is the sum of the BCS and the physical and functional well-being subscales, with scores ranging from 0 to 92. The total FACT-B score ranges from 0 to 144, where higher scores indicate better HRQoL.
次要结局
- Vaginal Health Index (VHI)(Baseline (before intervention) (A0); immediately after completing the intervention (A1), and at 3 months (A2), 6 months (A3), and 12 months (A4) following A1.)
- Impact of Vaginal Symptoms(Baseline (before intervention) (A0); immediately after completing the intervention (A1), and at 3 months (A2), 6 months (A3), and 12 months (A4) following A1.)
- Pelvic Floor Dysfunction Symptoms(Baseline (before intervention) (A0); immediately after completing the intervention (A1), and at 3 months (A2), 6 months (A3), and 12 months (A4) following A1.)
- Treatment Satisfaction(Baseline (before intervention) (A0); immediately after completing the intervention (A1), and at 3 months (A2), 6 months (A3), and 12 months (A4) following A1.)
- Pelvic Floor Muscle Tone(Baseline (before intervention) (A0); immediately after completing the intervention (A1), and at 3 months (A2), 6 months (A3), and 12 months (A4) following A1.)
- Pelvic Floor Muscle Strength(Baseline (before intervention) (A0); immediately after completing the intervention (A1), and at 3 months (A2), 6 months (A3), and 12 months (A4) following A1.)
- Pelvic Floor Muscle Contraction(Baseline (before intervention) (A0); immediately after completing the intervention (A1), and at 3 months (A2), 6 months (A3), and 12 months (A4) following A1.)
- Pelvic Floor Elasticity(Baseline (before intervention) (A0); immediately after completing the intervention (A1), and at 3 months (A2), 6 months (A3), and 12 months (A4) following A1.)
研究者
Maria Torres Lacomba
Full Professor
University of Alcala