Status:
RECRUITING
Lasertherapy for Vulvodynia
Lead Sponsor:
Medical University of Graz
Conditions:
Vulvodynia
Eligibility:
FEMALE
18-80 years
Phase:
NA
Brief Summary
The study aims to assess the efficacy, acceptance and safety profile of vulvovaginal laser therapy in women with vulvodynia.
Detailed 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...
Eligibility Criteria
Inclusion
- Women with vulvodynia (diagnosed according to the 2015 Consensus Terminology)
- multidisciplinary treatment for at least 3 months
- Informed consent
Exclusion
- 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
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2026
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04711369
Start Date
January 15 2021
End Date
July 30 2026
Last Update
March 4 2025
Active Locations (1)
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1
Department of Obstetrics and Gynecology/ Medical University of Graz
Graz, Austria, 8036