Lasertherapy for Vulvodynia

NARecruitingINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

January 15, 2021

Primary Completion Date

January 15, 2026

Study Completion Date

July 30, 2026

Conditions
Vulvodynia
Interventions
DEVICE

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."

DEVICE

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."

Trial Locations (1)

8036

RECRUITING

Department of Obstetrics and Gynecology/ Medical University of Graz, Graz

All Listed Sponsors
lead

Medical University of Graz

OTHER