Laser therapy for vulvodynia treatment
Lasertherapy for Vulvodynia
This study is testing whether laser therapy can help women with vulvodynia feel less pain and improve their sexual health and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Medical University of Graz Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Graz) |
| Trial ID | NCT04711369 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of Erbium:Yag laser therapy in women suffering from vulvodynia. It is a randomized, double-blinded, sham-controlled study designed to compare the outcomes of actual laser treatment against a placebo. The primary focus is on measuring pain reduction through standardized tests, while secondary outcomes include improvements in sexual health and quality of life. Participants will undergo a thorough screening process to ensure eligibility based on specific inclusion and exclusion criteria.
Who should consider this trial
Good fit: Ideal candidates are women diagnosed with vulvodynia who have undergone multidisciplinary treatment for at least three months.
Not a fit: Patients with current genital infections, inflammatory vulvar diseases, or other specified exclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce vulvar pain and improve the quality of life for women with vulvodynia.
How similar studies have performed: While there is limited data on laser therapy for vulvodynia, similar approaches in treating other chronic pain conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Graz
- Department of Obstetrics and Gynecology/ Medical University of Graz — Graz, Austria (Recruiting)
Study contacts
- Study coordinator: Gerda Trutnovsky, MD
- Email: gerda.trutnovsky@medunigraz.at
- Phone: +43 316 385
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.