Lasertherapy for Vulvodynia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 92
- 试验地点
- 3
- 主要终点
- Change of Vestibular pain index
研究概览
简要总结
The study aims to assess the efficacy, acceptance and safety profile of vulvovaginal laser therapy in women with vulvodynia.
详细描述
Randomized double blinded sham-controlled clinical study
Main hypothesis:
Laser therapy will be more effective than sham laser therapy in vulvar pain reduction measured by Q-tip test and tampon test
Secondary study hypotheses Laser therapy, in comparison to sham laser therapy
- will lead to more improvement of Sexual Health and HrQoL
- will have similar rates of side effects
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)
盲法说明
Sham-controlled
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with vulvodynia (diagnosed according to the 2015 Consensus Terminology)
- •multidisciplinary treatment for at least 3 months
- •Informed consent
排除标准
- •Current genital infection (i.e. candidiasis, herpes )
- •Inflammatory vulvar disease/ dermatosis (i.e. lichen sclerosus, lichen planus)
- •Neoplastic vulvar disease (e.g. HSIL Vulva, Paget disease)
- •Recent vulvar trauma (i.e. bleeding, erosion or ulceration)
- •Pudendal neuralgia
- •Pregnancy, delivery <6 months
- •Epilepsy or major neurologic or psychiatric morbidity
- •Active systemic infection
- •Previous treatment with ionizing radiation in the area to be treated
- •History of wound healing disorders (i.e. hyperpigmentation, abnormal scarring)
- •Systemic or local autoimmune disorders
- •History of photosensitivity disorder
研究组 & 干预措施
Control group (sham laser therapy)
Participants allocated to the control group will receive 2 sham laser treatments over a period of 3 months. Laser therapy will be performed according to a standardized protocol.
干预措施: Sham Erbium:Yag laser (Device)
Intervention group (laser therapy)
Participants allocated to the laser-therapy group will receive 2 laser treatments over a period of 3 months. Laser therapy will be performed according to a standardized protocol.
干预措施: Erbium:Yag laser (Device)
结局指标
主要结局
Change of Vestibular pain index
时间窗: Baseline and final assessment (3 months).
The Vestibular pain index is derived from the Q-tip test and the tampon test. A standardized Q-Tip test (MRC Systems GmbH, Heidelberg, Germany), developed for quantitative sensoric testing, will be used. Pain on six defined anatomical regions of the vulvar vestibule (at 2 ,5,6,7,10 and 12 o clock) will be assessed. Patients will be asked to rate the level of vulvar pain on a numeric rating scale (NRS) of 0 "none at all" to 10 "worst imaginable". The tampon test is a standardized tampon insertion and removal test. The vestibular pain index will be calculated as follows: (mean NRS score of the standardized Q-tip test (6 sites) + NRS score during the tampon test) / 2
次要结局
- Change in Pain sensitivity questionnaire (PSQ)(Baseline and final assessment (3 months).)
- Change in Treatment discomfort(Twice after treatment, one and two months after baseline)
- Change in Treatment pain(Twice after treatment, one and two months after baseline)
- Change of pelvic floor muscle (PFM) function- PFM contraction strength(Baseline and final assessment (3 months).)
- Change of levator hiatal dimensions at rest(Baseline and final assessment (3 months).)
- Change in Endometriosis Health Profile (EHP-30)(Baseline and final assessment (3 months).)
- Change in Patient Health Questionnaire (PHQ-D)(Baseline and final assessment (3 months).)
- Change of pelvic floor muscle (PFM) function- PFM tone(Baseline and final assessment (3 months).)
- Change of levator hiatal dimensions at maximal voluntary contraction(Baseline and final assessment (3 months).)
- Change of levator hiatal dimensions at maximal Valsalva maneuver(Baseline and final assessment (3 months).)
- Change of Sexual activity(Baseline and final assessment (3 months).)
- Change in Patient Global Impression of Improvement (PGI-I)(Baseline and final assessment (3 months).)
- Change of Vaginal health score index (VHSI)(Baseline and final assessment (3 months).)
- Change of Sexual Function(Baseline and final assessment (3 months).)
- Change in German Pain Assessment (assessed by Deutscher Schmerzfragebogen/DSF)(Baseline and final assessment (3 months).)
- Change in Patient treatment satisfaction(Baseline and final assessment (3 months).)