Actively Recruiting
Lasertherapy for Vulvodynia
Led by Medical University of Graz · Updated on 2025-03-04
92
Participants Needed
1
Research Sites
28 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness, acceptance, and safety of vulvovaginal laser therapy in women diagnosed with vulvodynia. The study is a randomized, double-blinded, sham-controlled clinical trial designed to compare laser therapy with sham laser therapy in reducing vulvar pain, assessed by tests such as the Q-tip and tampon tests. Secondary goals include measuring improvements in sexual health, quality of life, and side effect rates between the two groups. Participants are randomly assigned to one of two groups: the active laser therapy group or the sham laser therapy group. Those in the laser therapy group will receive two treatments over three months using a non-ablative 2940 nm Er:YAG laser according to a standardized protocol. The control group will receive two sham treatments using the same procedures but with a placebo probe that blocks laser emission, ensuring no therapeutic radiation is delivered. During the study, participants will undergo assessments at baseline and after three months to measure changes in vestibular pain, pelvic floor muscle function, levator hiatal dimensions, vaginal health, sexual activity and function, and various health and pain questionnaires. Treatment discomfort and pain will also be evaluated twice after treatment. The study includes safety monitoring and patient satisfaction evaluations throughout the treatment period.
CONDITIONS
Brief Title
Lasertherapy for Vulvodynia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with vulvodynia diagnosed according to the 2015 Consensus Terminology
- Received multidisciplinary treatment for at least 3 months
- Provided informed consent to participate
You will not qualify if you...
- Current genital infection such as candidiasis or herpes
- Inflammatory vulvar diseases like lichen sclerosus or lichen planus
- Neoplastic vulvar diseases including HSIL Vulva or Paget disease
- Recent vulvar trauma such as bleeding, erosion, or ulceration
- Pudendal neuralgia diagnosis
- Pregnant or delivered within the last 6 months
- Epilepsy or major neurological or psychiatric disorders
- Active systemic infection
- Previous ionizing radiation treatment in the area to be treated
- History of wound healing disorders such as abnormal scarring
- Fever at the time of assessment
- Systemic or local autoimmune disorders
- History of photosensitivity disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive 2 laser or sham laser treatments over a period of 3 months following a standardized protocol.
2 treatment visits over 3 months
Duration - 2 months after treatment start
Participants complete assessments of treatment pain and discomfort at 1 and 2 months after baseline.
2 follow-up visits at 1 and 2 months after baseline
Trial Site Locations
Total: 1 location
1
Department of Obstetrics and Gynecology/ Medical University of Graz
Graz, Austria, 8036
Actively Recruiting
Research Team
G
Gerda Trutnovsky, MD
K
Karl Tamussino, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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