Lasertherapy for Vulvodynia

Study Overview
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Brief Summary
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The study aims to assess the efficacy, acceptance and safety profile of vulvovaginal laser therapy in women with vulvodynia.

Detailed Description
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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

Official Title
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Lasertherapy for Vulvodynia

Conditions
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Vulvodynia

Intervention / Treatment
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* Device: Erbium:Yag laser
* Device: Sham Erbium:Yag laser


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized double blinded sham-controlled clinical study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group (laser therapy)<br>Participants allocated to the laser-therapy group will receive 2 laser treatments over a period of 3 months. Laser therapy will be performed according to a standardized protocol. | Device: Erbium:Yag laser<br>* 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.<br>|
| Sham Comparator: Control group (sham laser therapy)<br>Participants allocated to the control group will receive 2 sham laser treatments over a period of 3 months. Laser therapy will be performed according to a standardized protocol. | Device: Sham Erbium:Yag laser<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline and final assessment (3 months). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline and final assessment (3 months). | 
| 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. | Baseline and final assessment (3 months). | 
| Change of levator hiatal dimensions at rest | 3D perineal ultrasound will be used to measure levator hiatal dimensions at rest | Baseline and final assessment (3 months). | 
| Change of levator hiatal dimensions at maximal voluntary contraction | 3D perineal ultrasound will be used to measure levator hiatal dimensions at maximal voluntary contraction | Baseline and final assessment (3 months). | 
| Change of levator hiatal dimensions at maximal Valsalva maneuver | 3D perineal ultrasound will be used to measure levator hiatal dimensions at maximal Valsalva maneuver | Baseline and final assessment (3 months). | 
| Change of Vaginal health score index (VHSI) | In postmenopausal women the VHSI will be performed to assess elasticity, fluid volume, pH, epithelial integrity and a moisture on a scale from 1 (none) to 5 (excellent) each. The sum score will be recorded. | Baseline and final assessment (3 months). | 
| Change of Sexual activity | Participants will be asked to complete a study diary and record whether they experienced sexual intercourse. Possible answers are: #1-No, too painful indicating that the woman could not accept an approach to physical intimacy because of pain, #2 -No, not interested, indicating that the subject was not in the mood for sexual intimacy, #3-No,no opportunity, indicating that her partner was not available, #4-Yes meaning that an attempt at sexual intercourse was made. If intercourse was attempted the level of pain during intercourse should be rated on a 0 - 10 NRS pain scale. | Baseline and final assessment (3 months). | 
| Change of Sexual Function | The German version of the Female Sexual Function Index (FSFI-d) will be used to assess women´s sexuality. The validated 19-item questionnaire examines several aspects of female sexuality, i.e. sexual arousal, orgasm and dyspareunia. | Baseline and final assessment (3 months). | 
| Change in Endometriosis Health Profile (EHP-30) | The EHP-30 consists of five scales -pain, control and powerlessness, emotional well-being, social support, and self-image (30 items) and a module with 23 items. The modular part consists of six scales - work, relationship with children, sexual intercourse, infertility, medical profession, and treatment. | Baseline and final assessment (3 months). | 
| Change in German Pain Assessment (assessed by Deutscher Schmerzfragebogen/DSF) | The DSF was developed for the comprehensive assessment and therapy planning of patients with chronic pain conditions. The modules on pain assessment (e.g. pain characteristics, relieving and aggravating factors) and on demographic information will be used. | Baseline and final assessment (3 months). | 
| Change in Patient Health Questionnaire (PHQ-D) | The PHQ-D is a sensitive screening tool for detecting depressive symptoms in a general patient population. The 9-item tool assesses the degree and severity of depression, and has been found to be a valid and useful tool for therapy evaluation | Baseline and final assessment (3 months). | 
| Change in Pain sensitivity questionnaire (PSQ) | The PSQ is an instrument for the assessment of pain sensitivity based on pain intensity self ratings of daily life situations | Baseline and final assessment (3 months). | 
| Change in Patient Global Impression of Improvement (PGI-I) | The Patient Global Impression of Improvement (PGI-I), a valid instrument with a 7-step Likert type response scale, will be used to assess subjective improvement after treatment. After three months, i.e. one month after the second laser therapy, women will be asked to rate the change in vulvar pain. | Baseline and final assessment (3 months). | 
| Change in Patient treatment satisfaction | Treatment satisfaction will be assessed using an adopted version of the Fragebogen zur Patientenzufriedenheit - ZUF8. The questionnaire, the German version of the original Client Satisfaction Questionnaire-CSQ8, is a tool for measuring global patient satisfaction at the end of inpatient treatment | Baseline and final assessment (3 months). | 
| Change in Treatment discomfort | At the end of each treatment session patients are asked to indicate the degree of discomfort during laser therapy on a NRS ranging from 0 no discomfort to 10 worst possible discomfort | Twice after treatment, one and two months after baseline | 
| Change in Treatment pain | At the end of each treatment session patients are asked to indicate the degree of pain during laser therapy on a NRS ranging from 0 no pain to 10 worst possible pain. | Twice after treatment, one and two months after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erbium:Yag laser