Clinical trial NCT04711369: Lasertherapy for Vulvodynia
Official title: Lasertherapy for Vulvodynia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vulvodynia
Keywords: Erbium:Yag laser
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized double blinded sham-controlled clinical study
Primary purpose: TREATMENT

Brief summary: 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

Eligibility 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

Primary outcomes:
measure: Change of Vestibular pain index
timeFrame: Baseline and final assessment (3 months).
Secondary outcomes:
measure: Change of pelvic floor muscle (PFM) function- PFM contraction strength
timeFrame: Baseline and final assessment (3 months).
measure: Change of pelvic floor muscle (PFM) function- PFM tone
timeFrame: Baseline and final assessment (3 months).
measure: Change of levator hiatal dimensions at rest
timeFrame: Baseline and final assessment (3 months).
measure: Change of levator hiatal dimensions at maximal voluntary contraction
timeFrame: Baseline and final assessment (3 months).
measure: Change of levator hiatal dimensions at maximal Valsalva maneuver
timeFrame: Baseline and final assessment (3 months).
measure: Change of Vaginal health score index (VHSI)
timeFrame: Baseline and final assessment (3 months).
measure: Change of Sexual activity
timeFrame: Baseline and final assessment (3 months).
measure: Change of Sexual Function
timeFrame: Baseline and final assessment (3 months).
measure: Change in Endometriosis Health Profile (EHP-30)
timeFrame: Baseline and final assessment (3 months).
measure: Change in German Pain Assessment (assessed by Deutscher Schmerzfragebogen/DSF)
timeFrame: Baseline and final assessment (3 months).
measure: Change in Patient Health Questionnaire (PHQ-D)
timeFrame: Baseline and final assessment (3 months).
measure: Change in Pain sensitivity questionnaire (PSQ)
timeFrame: Baseline and final assessment (3 months).
measure: Change in Patient Global Impression of Improvement (PGI-I)
timeFrame: Baseline and final assessment (3 months).
measure: Change in Patient treatment satisfaction
timeFrame: Baseline and final assessment (3 months).
measure: Change in Treatment discomfort
timeFrame: Twice after treatment, one and two months after baseline
measure: Change in Treatment pain
timeFrame: Twice after treatment, one and two months after baseline
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Department of Obstetrics and Gynecology/ Medical University of Graz
Study officials:
References: