Lasertherapy for Vulvodynia

Lasertherapy for Vulvodynia

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

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

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