Lasertherapy for Vulvodynia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vulvodynia
- Sponsor
- Medical University of Graz
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Change of Vestibular pain index
- Status
- Recruiting
- Last Updated
- last year
Overview
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
Investigators
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)
Outcomes
Primary Outcomes
Change of Vestibular pain index
Time Frame: Baseline and final assessment (3 months).
The Vestibular pain index is derived from the Q-tip test and the tampon test. A standardized Q-Tip test (MRC Systems GmbH, Heidelberg, Germany), developed for quantitative sensoric testing, will be used. Pain on six defined anatomical regions of the vulvar vestibule (at 2 ,5,6,7,10 and 12 o clock) will be assessed. Patients will be asked to rate the level of vulvar pain on a numeric rating scale (NRS) of 0 "none at all" to 10 "worst imaginable". The tampon test is a standardized tampon insertion and removal test. The vestibular pain index will be calculated as follows: (mean NRS score of the standardized Q-tip test (6 sites) + NRS score during the tampon test) / 2
Secondary Outcomes
- Change in Pain sensitivity questionnaire (PSQ)(Baseline and final assessment (3 months).)
- Change in Treatment discomfort(Twice after treatment, one and two months after baseline)
- Change in Treatment pain(Twice after treatment, one and two months after baseline)
- Change of pelvic floor muscle (PFM) function- PFM contraction strength(Baseline and final assessment (3 months).)
- Change of levator hiatal dimensions at rest(Baseline and final assessment (3 months).)
- Change in Endometriosis Health Profile (EHP-30)(Baseline and final assessment (3 months).)
- Change in Patient Health Questionnaire (PHQ-D)(Baseline and final assessment (3 months).)
- Change of pelvic floor muscle (PFM) function- PFM tone(Baseline and final assessment (3 months).)
- Change of levator hiatal dimensions at maximal voluntary contraction(Baseline and final assessment (3 months).)
- Change of levator hiatal dimensions at maximal Valsalva maneuver(Baseline and final assessment (3 months).)
- Change of Sexual activity(Baseline and final assessment (3 months).)
- Change in Patient Global Impression of Improvement (PGI-I)(Baseline and final assessment (3 months).)
- Change of Vaginal health score index (VHSI)(Baseline and final assessment (3 months).)
- Change of Sexual Function(Baseline and final assessment (3 months).)
- Change in German Pain Assessment (assessed by Deutscher Schmerzfragebogen/DSF)(Baseline and final assessment (3 months).)
- Change in Patient treatment satisfaction(Baseline and final assessment (3 months).)