Efficacy of K-laser as a Therapeutic Treatment of the Symptoms of Genitourinary Syndrome of Menopause (SGM) in Postmenopausal Women: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Change from Baseline in Vaginal pH
研究概览
简要总结
This is a prospective, multi-centre, double blinded, randomized controlled trial, which will be conducted under a common protocol.
The aim of this study is to evaluate the efficacy of vaginal laser for treatment of GSM (Genitourinary Syndrome of Menopause) compared to the sham procedure in postmenopausal women.
The study population is female subjects > 18 years old with symptoms of genitourinary syndrome of menopause (GSM) who have not menstruated for at least 5 years.
详细描述
The clinical data will be analysed by comparing post-treatment data with the baseline data (clinical history, compliance with selection, inclusion and exclusion requirements, assessment of the muscle and pH, and questionnaires). The follow-up is for 6 weeks after the procedure, a physical examination will be passed again to assess whether the effects on the tissue are maintained once the treatment is finished (coloration, hydration, and mobility of the tissue). Two biopsies will be taken, once at the beginning of treatment and another at the end.
The symptoms of SGM worsen as the age of the subject advances, which is why a treatment is required that improves the symptoms in the long term and maintains them once the treatment is finished. For this reason, the objective is to carry out a randomized control study with a new K-Laser Cube device that minimizes the possible risks of conventional vaginal laser therapy.
The hypothesis is that women who will undergo vaginal K-Laser treatment will report an improvement not only in SGM, but also in pelvic floor dysfunctions. The objective in this pilot study will be to evaluate the effects of K-laser treatment on pelvic floor dysfunctions using validated and commonly used questionnaires.
Changes in vaginal pH measured by FSFI (Female Sexual Function Index) questionnaire and changes in the deep musculature with the PERFECT protocol and the OXFORD scale will be the primary endpoints of the study. The secondary endpoints include quality of life changes with the SF-12 (Short Form) health questionnaire and Cervantes Scale, CPPQ-Mohedo (Chronic Pelvic Pain Floor) questionnaire, PFDI-20 (Pelvic Floor Distress Inventory) questionnaire and the Menopause Rating Scale (MSR).
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women of any age with established menopause of 5 years or more who report genitourinary discomfort, dyspareunia, sequelae, genital atrophy, voiding discomfort, voiding urgency or urinary incontinence. Postmenopausal status is defined if patients have at least 12 continuous months of amenorrhea for no other apparent reason or permanently elevated follicle-stimulating hormone (FSH) blood levels (≥30 mIU/mL).
- •Patients who have had cancer treatment already completed and in the process of remission.
- •Sexually active
- •Nulliparous or who have had vaginal deliveries or caesarean section
- •That they do not receive hormone replacement therapy in any of its routes of administration. If you received HRT, 4 months must have elapsed since stopping treatment before starting the trial protocol.
- •Motivated and committed to complete the trial
排除标准
- •According to the pelvic organ prolapse quantification system [POP-Q], POP>Stage 2, , severe urinary or fecal incontinence (FI) or any disease that could influence the study protocol. In addition, patients will be advised to refrain from vaginal practices for three days prior to each biopsy (one at the beginning and one at the end of treatment).
- •Women who are not sexually active, do not have coital relationships, either with a partner or alone
- •Women with recurrent cystitis or candidiasis
- •Women with little motivation to participate in the trial
- •Patients who do not have the ability to comprehend or understand what participation in a clinical trial entail
- •Patients with severe psychiatric pathology (depression, anxiety)
- •Patients with degenerative neurological pathology: either cognitive impairment or ALS, MS, diabetic neuropathy, etc.
- •Patients with neuropathic genital pain (neuralgia or pudendal nerve entrapment)
- •Vulvodynia, hyperalgesia, or genital allodynia
- •Post-pelvic surgery of less than 3 months
结局指标
主要结局
Change from Baseline in Vaginal pH
时间窗: The evaluation will be done at baseline before treatment and 6 weeks post treatment
During the physical examination a sample of the mucosa will be extracted to check the acidity of the pH. This is a marker of the health of the vaginal flora and abnormalities in pH values will be determined by hormonal imbalances of oestrogens. A pH\> 4.5 refers to a decrease in local vaginal defenses which predisposes to infections or inflammatory processes. The pH analysis is a valid tool to diagnose menopause equivalent to an analysis of the levels of the follicle-stimulating molecule (FSH) non-invasive and inexpensive.
Change from Baseline in the deep musculature with the PERFECT protocol
时间窗: The evaluation will be done at baseline before treatment and 6 weeks post treatment
Digital evaluation is essential during the examination of the pelvic floor muscles. For this, digital palpation and a pressure gauge will be used. Digital assessment is performed by inserting the index and middle fingers into the distal 3 centimetres of the vagina in a frontal plane. The PERFECT protocol is described as an acronym for evaluating the main components of pelvic floor muscle contractility. The components are: P (power, score muscle strength according to the OXFORD scale), E (endurance, time the maximum contraction is maintained without loss of strength), R (repetitions, number of contractions with intervals of 4 to 10 seconds), F (number of fast contractions followed after a rest of 1 minute), ECT (every contraction timed: each contraction measured) that consists in evaluating each contraction before the beginning of the treatment, which allows individualizing the program.
Analysis of the impact on QoL (Quality of life) with the FSFI (Female Sexual Function Index) questionnaire.
时间窗: The evaluation will be done at baseline before treatment and 6 weeks post treatment
FSFI questionnaire assesses sexual function in women with pelvic floor dysfunction. It consists of 6 domains and 19 items (Cronbach's alpha coefficient =0.85). The maximum score is 36.0 (high level of sexual functional) and minimum score is 2.0 (low level of sexual functional). The domains are: desire (2 items), arousal (4 items), lubrication (4 items), orgasm (3 items), satisfaction (3 items), pain (3 items).
次要结局
- Analysis of the impact on QoL (Quality of life) with Cervantes Scale(The evaluation will be done at baseline before treatment and 6 weeks post treatment)
- Evaluation of the impact of pelvic floor dysfunction symptoms with the PFDI-20 (Pelvic Floor Distress Inventory) questionnaire(The evaluation will be done at baseline before treatment and 6 weeks post treatment)
- Analysis of the impact on QoL (Quality of life) with the SF-12 (Short Form) health questionnaire.(The evaluation will be done at baseline before treatment and 6 weeks post treatment)
- Assessment of pain with the CPPQ-Mohedo (Chronic Pelvic Pain Floor) questionnaire(The evaluation will be done at baseline before treatment and 6 weeks post treatment)
- Assesment of menopausal symptoms with the Menopause Rating Scale (MSR).(The evaluation will be done at baseline before treatment and 6 weeks post treatment)
研究者
Rocío Martín Valero
PhD
University of Malaga