Overview
The study aims to assess the efficacy, acceptance and safety profile of vulvovaginal laser therapy in women with vulvodynia.
Description
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
Eligibility
Inclusion Criteria:
- Women with vulvodynia (diagnosed according to the 2015 Consensus Terminology)
- multidisciplinary treatment for at least 3 months
- Informed consent
Exclusion Criteria:
- 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