Lasertherapy for Vulvodynia
Medical University of Graz
92 participants
Jan 15, 2021
INTERVENTIONAL
Conditions
Summary
The study aims to assess the efficacy, acceptance and safety profile of vulvovaginal laser therapy in women with vulvodynia.
Eligibility
Inclusion Criteria3
- Women with vulvodynia (diagnosed according to the 2015 Consensus Terminology)
- multidisciplinary treatment for at least 3 months
- Informed consent
Exclusion Criteria13
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Vulvovaginal laser therapies will be performed with the non-ablative 2940 nm Er:YAG laser (Smooth XS, Fotona, Slovenia) in the Renova mode according to the manufacturer's guidelines and recommendations. The spot size (diameter of the laser beam) is 7 mm, with a pulse at a frequency of 1.6 Hz, and a fluence (laser energy delivered per unit area) of 5.0 to 10.0 J/cm2. All sensitive/painful areas of the introitus will be treated, using 1-3 repetitions. In postmenopausal women with signs of atrophy, additional irradiation of the vaginal wall will be performed.
Clinical examination and preparations will be identical to the intervention group. Sham laser treatments will be performed with the same laser and the same procedures. However, a specially devised placebo probe with a steel shutter, which blocks the emission of radiation, will be used. Women will therefore receive no therapeutic irradiation. Before treatment, a study assistant, who is aware of the study allocation, will prepare the laser with the placebo probe, which looks identically to the "normal" probe. The treating physician will not be aware of the study allocation and the type of probe in use.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04711369