Lasertherapy for Vulvodynia (Lydia)

Medical University of Graz

Status: Enrolling

Conditions: Vulvodynia

Treatments: Device: Sham Erbium:Yag laser; Device: Erbium:Yag laser

Study type: Interventional

Funder types: Other

Identifiers

NCT04711369

32-187 ex 19/20

Details and patient eligibility

About

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

Full 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

Enrollment: 92 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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92 participants in 2 patient groups

Intervention group (laser therapy)

Active Comparator group

Description:

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.

Treatment:

Device: Erbium:Yag laser

Control group (sham laser therapy)

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Erbium:Yag laser