92
Participants
Start Date
January 15, 2021
Primary Completion Date
January 15, 2026
Study Completion Date
July 30, 2026
Erbium:Yag laser
"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."
Sham Erbium:Yag laser
"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."
RECRUITING
Department of Obstetrics and Gynecology/ Medical University of Graz, Graz
Medical University of Graz
OTHER