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Can a laser beam silence chronic vulvar pain?

NCT ID NCT04711369

Symptom relief Sponsor: Medical University of Graz Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This trial asks whether a special laser, called Er:YAG, can reduce pain in women with vulvodynia—a condition causing chronic pain in the vulvar area without a clear cause. About 92 women who have already tried other treatments for at least three months will receive either real laser therapy or a sham (fake) procedure. Researchers will measure pain using a standardized cotton-swab test and a tampon test, and also check pelvic floor muscle function and safety. The goal is to see if this non-invasive approach offers a new way to ease symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Erbium:YAG laser treatment (non-ablative 2940 nm laser applied to painful vulvar areas)
What this could lead to
If effective, this could offer a non-drug, non-surgical option to reduce chronic vulvar pain and improve quality of life for women with vulvodynia.
What could go wrong
This is an early-stage trial with a sham comparison, so results may show no benefit over placebo. Laser treatment may also cause temporary discomfort or irritation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 92 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

vulvodynia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Vulvodynia

Contacts and locations

Locations

  • Department of Obstetrics and Gynecology/ Medical University of Graz

    Graz, 8036, Austria

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