Lasertherapy for vulvodynia

Vulvodynia is defined as vulvar pain of at least three months duration without a clear identifiable cause. Prevalence studies conducted in Anglo-American countries indicate that between 8 and 10 % of women are affected by vulvodynia. However, many of them may not have been diagnosed with the condition. In German speaking countries the diagnosis vulvodynia is still rather unknown, since it is rarely mentioned in medical textbooks. Therefore many affected women are not properly diagnosed and treated. Treatment for vulvodynia is challenging. Multidisciplinary therapy plans, which combine medical treatments with physiotherapy, psychological interventions and complementary medicine, have been shown to provide the highest success rates. In the last few years microablative and non-ablative laser systems have been increasingly used for the treatment of gynecological symptoms. Treatments can be easily performed with local anaesthesia in an outpatient setting. There is some evidence that vulvar laser therapy may also improve symptoms in women with vulvodynia. The current LYDIA study aims to examine the efficacy, acceptance and safety of laser treatment for women with vulvodynia. Women presenting to the gynaecologic pain clinic of the Medical University of Graz, who are diagnosed with vulvodynia, will be invited to participate in the study. Patients will be randomised to the real- laser therapy group or the sham-laser therapy group, without knowing their study group allocation. All study participants will receive two treatments with an Erbium:Yag laser in an outpatient setting. In the sham-laser group the laser beam will be blocked, and therefore no irradiation will occur. During the three-months treatment period participating women will be asked to refrain from any other new treatment modalities for vulvodynia. However, it will be allowed to continue ongoing treatments. The study outcomes will be assessed three and six months after the first laser therapy. A range of questionnaires and clinical tests will be used to examine the effect of laser therapy on local pain, quality-of-life and sexuality. Potential adverse effect and treatment satisfaction will be monitored during the entire study period. We intent to include 92 patients with vulvodynia in this study. Total study duration is expected to be 36 months.

The recruitment of the LYDIA study is still ongoing and the study duration has been extended. Therefore no final study data can be submitted at this stage, but will be forwarded after study completion and final data analysis. Subsequently the publication in a peer-reviewed journal can be expected. The aim of the LYDIA study is to assess the effectiveness of non-ablative vulvovaginal laser therapy as part of a multidisciplinary treatment for women with vulvodynia. Treatment for vulvodynia is challenging and vulvovaginal laser therapy may be an additional effective treatment option. This randomized blinded placebo- controlled clinical study plans to recruit 92 women diagnosed with vulvodynia. At this stage we managed to include 64 women (70%), and 51 study patients completed the follow-up visits. In this study local vulvar pain, sexual function, pelvicfloor function and Health-related Quality-of-Life will be analysed by clinical examination and questionnaires. In addition treatment discomfort, side effects and patient treatment satisfaction will be assessed. During the entire study period no suspected unexpected serious adverse reactions (SUSARs) have occurred. The study has been conducted according to study plan with good overall patient satisfaction.