Lasertherapy for Vulvodynia
ConditionVulvodynia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorMedical University of Graz
About this trial
The study aims to assess the efficacy, acceptance and safety profile of vulvovaginal laser therapy in women with vulvodynia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women with vulvodynia (diagnosed according to the 2015 Consensus Terminology)
multidisciplinary treatment for at least 3 months
Informed consent
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Erbium:Yag laser
DeviceVulvovaginal 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
DeviceClinical 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.
Treatment groups
92 Participants
are divided into 2 treatment groupsGroup A: Intervention group (laser therapy)Active comparator 1 intervention
Group B: Control group (sham laser therapy)Sham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change of Vestibular pain index
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
Time frame
Baseline and final assessment (3 months).Secondary outcomes
1
Change of pelvic floor muscle (PFM) function- PFM contraction strength
The Modified Oxford Scale (MOS) will be used to score maximal PFM contraction strength, ranging from 0 (no contraction) to 5 (strong contraction and lift).
Time frame
Baseline and final assessment (3 months).2
Change of pelvic floor muscle (PFM) function- PFM tone
PFM tone will be scored on a 7-point PFM tone scale ranging from -3 (very hypotonic) to +3 (very hypertonic), with 0 representing a "normal" pelvic muscle tone.
Time frame
Baseline and final assessment (3 months).3
Change of levator hiatal dimensions at rest
3D perineal ultrasound will be used to measure levator hiatal dimensions at rest
Time frame
Baseline and final assessment (3 months).4
Change of levator hiatal dimensions at maximal voluntary contraction
3D perineal ultrasound will be used to measure levator hiatal dimensions at maximal voluntary contraction
Time frame
Baseline and final assessment (3 months).Sponsors and contacts
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Source ClinicalTrials.gov