Recruiting NCT04711369

Lasertherapy for Vulvodynia

No phase Interventional Vulvodynia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Erbium:Yag laser, Sham Erbium:Yag laser.
Who it may be relevant to: Registry conditions: Vulvodynia. Basic parameters: 18 years — 80 years · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Austria
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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

Secondary study hypotheses Laser therapy, in comparison to sham laser therapy

* will lead to more improvement of Sexual Health and HrQoL * will have similar rates of side effects

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 atroph
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 "no

Change of Vestibular pain index [Time frame: Baseline and final assessment (3 months).]

Secondary outcome measures (12)

Change of pelvic floor muscle (PFM) function- PFM contraction strength [Time frame: Baseline and final assessment (3 months).]
Change of pelvic floor muscle (PFM) function- PFM tone [Time frame: Baseline and final assessment (3 months).]
Change of levator hiatal dimensions at rest [Time frame: Baseline and final assessment (3 months).]
Change of levator hiatal dimensions at maximal voluntary contraction [Time frame: Baseline and final assessment (3 months).]
Change of levator hiatal dimensions at maximal Valsalva maneuver [Time frame: Baseline and final assessment (3 months).]
Change of Vaginal health score index (VHSI) [Time frame: Baseline and final assessment (3 months).]
Change of Sexual activity [Time frame: Baseline and final assessment (3 months).]
Change of Sexual Function [Time frame: Baseline and final assessment (3 months).]
Change in Endometriosis Health Profile (EHP-30) [Time frame: Baseline and final assessment (3 months).]
Change in German Pain Assessment (assessed by Deutscher Schmerzfragebogen/DSF) [Time frame: Baseline and final assessment (3 months).]
Change in Patient Health Questionnaire (PHQ-D) [Time frame: Baseline and final assessment (3 months).]
Change in Pain sensitivity questionnaire (PSQ) [Time frame: Baseline and final assessment (3 months).]

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Austria · 1 center

NCT: NCT04711369 · 32-187 ex 19/20