Lasertherapy for Vulvodynia

Обзор

The study aims to assess the efficacy, acceptance and safety profile of vulvovaginal laser therapy in women with vulvodynia.

Подробное описание

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

Вмешательства

• Устройство Erbium:Yag laser
  Vulvovaginal laser therapies will be performed with the non-ablative 2940 nm Er:YAG laser (Smooth XS, Fotona, Slovenia) in the Renova mode according to the manufacturer's guidelines and recommendations. The spot size (diameter of the laser beam) is 7 mm, with a pulse at a frequency of 1.6 Hz, and a fluence (laser energy delivered per unit area) of 5.0 to 10.0 J/cm2. All sensitive/painful areas of the introitus will be treated, using 1-3 repetitions. In postmenopausal women with signs of atroph
• Устройство Sham Erbium:Yag laser
  Clinical examination and preparations will be identical to the intervention group. Sham laser treatments will be performed with the same laser and the same procedures. However, a specially devised placebo probe with a steel shutter, which blocks the emission of radiation, will be used. Women will therefore receive no therapeutic irradiation. Before treatment, a study assistant, who is aware of the study allocation, will prepare the laser with the placebo probe, which looks identically to the "no

Первичные конечные точки

• Change of Vestibular pain index [Срок оценки: Baseline and final assessment (3 months).]

Вторичные конечные точки (12)

• Change of pelvic floor muscle (PFM) function- PFM contraction strength [Срок оценки: Baseline and final assessment (3 months).]
• Change of pelvic floor muscle (PFM) function- PFM tone [Срок оценки: Baseline and final assessment (3 months).]
• Change of levator hiatal dimensions at rest [Срок оценки: Baseline and final assessment (3 months).]
• Change of levator hiatal dimensions at maximal voluntary contraction [Срок оценки: Baseline and final assessment (3 months).]
• Change of levator hiatal dimensions at maximal Valsalva maneuver [Срок оценки: Baseline and final assessment (3 months).]
• Change of Vaginal health score index (VHSI) [Срок оценки: Baseline and final assessment (3 months).]
• Change of Sexual activity [Срок оценки: Baseline and final assessment (3 months).]
• Change of Sexual Function [Срок оценки: Baseline and final assessment (3 months).]
• Change in Endometriosis Health Profile (EHP-30) [Срок оценки: Baseline and final assessment (3 months).]
• Change in German Pain Assessment (assessed by Deutscher Schmerzfragebogen/DSF) [Срок оценки: Baseline and final assessment (3 months).]
• Change in Patient Health Questionnaire (PHQ-D) [Срок оценки: Baseline and final assessment (3 months).]
• Change in Pain sensitivity questionnaire (PSQ) [Срок оценки: Baseline and final assessment (3 months).]

Критерии участия

Критерии включения

• Women with vulvodynia (diagnosed according to the 2015 Consensus Terminology)
• multidisciplinary treatment for at least 3 months
• Informed consent

Критерии исключения

• 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)
• Fever
• Systemic or local autoimmune disorders
• History of photosensitivity disorder

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Австрия · 1 центр

• Department of Obstetrics and Gynecology/ Medical University of Graz — Graz

Идентификаторы

NCT: NCT04711369 · 32-187 ex 19/20

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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