VulvodyniaLydiaNCT04711369
Lasertherapy for Vulvodynia
A study testing Erbium:Yag laser in people with Vulvodynia, run by Medical University of Graz at 1 site in Austria.
Trial summary
The study aims to assess the efficacy, acceptance and safety profile of vulvovaginal laser therapy in women with vulvodynia. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Vulvodynia
- What is being tested?
- Erbium:Yag laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteAustria
- Study dates
- 15 Jan 2021to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with vulvodynia (diagnosed according to the 2015 Consensus Terminology)
- multidisciplinary treatment for at least 3 months
- Informed consent
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Obstetrics and Gynecology/ Medical University of Graz
Graz, 8036
About this study
The study aims to assess the efficacy, acceptance and safety profile of vulvovaginal laser therapy in women with vulvodynia.
Read the detailed description
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
- Conditions
- Vulvodynia
- Being tested
- Erbium:Yag laser, Sham Erbium:Yag laser
- Keywords
- Erbium:Yag laser
- Medical subject headings
- Vulvodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erbium:Yag laserDevice
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.
Sham Erbium:Yag laserDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (laser therapy) | Active comparator | 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. Receives: Device: Erbium:Yag laser |
| Control group (sham laser therapy) | Sham comparator | 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. Receives: Device: Sham Erbium:Yag laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and final assessment (3 months).
Secondary outcomes (16)
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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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"
Measured: 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".
Measured: Twice after treatment, one and two months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start15 Jan 2021
- Primary completion15 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VulvodyniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double blinded sham-controlled clinical study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711369
- Sponsor's protocol ID
- 32-187 ex 19/20
- Acronym
- Lydia
- Status last verified
- Aug 2026
- First submitted
- 15 Dec 2020
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lasertherapy for Vulvodynia
- ClinicalTrials.gov ID
- NCT04711369
- Acronym / sponsor ID
- Lydia / 32-187 ex 19/20
- Conditions
- Vulvodynia
- Keywords
- Erbium:Yag laser
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to assess the efficacy, acceptance and safety profile of vulvovaginal laser therapy in women with vulvodynia.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double blinded sham-controlled clinical study
| Arm | Type | Receives |
|---|---|---|
| Intervention group (laser therapy) | Active comparator | Device: Erbium:Yag laserParticipants 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. |
| Control group (sham laser therapy) | Sham comparator | Device: Sham Erbium:Yag laserParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women with vulvodynia (diagnosed according to the 2015 Consensus Terminology)
- multidisciplinary treatment for at least 3 months
- Informed consent
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erbium:Yag laserVulvovaginal 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. | Device | Intervention group (laser therapy) |
| Sham Erbium:Yag laserClinical 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. | Device | Control group (sham laser therapy) |
Primary outcome
Change of Vestibular pain index
Time frame: Baseline and final assessment (3 months).
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
16 secondary outcomes
Change of pelvic floor muscle (PFM) function- PFM contraction strength
Time frame: Baseline and final assessment (3 months).
Change of pelvic floor muscle (PFM) function- PFM tone
Time frame: Baseline and final assessment (3 months).
Change of levator hiatal dimensions at rest
Time frame: Baseline and final assessment (3 months).
Change of levator hiatal dimensions at maximal voluntary contraction
Time frame: Baseline and final assessment (3 months).
Change of levator hiatal dimensions at maximal Valsalva maneuver
Time frame: Baseline and final assessment (3 months).
Change of Vaginal health score index (VHSI)
Time frame: Baseline and final assessment (3 months).
Change of Sexual activity
Time frame: Baseline and final assessment (3 months).
Change of Sexual Function
Time frame: Baseline and final assessment (3 months).
Change in Endometriosis Health Profile (EHP-30)
Time frame: Baseline and final assessment (3 months).
Change in German Pain Assessment (assessed by Deutscher Schmerzfragebogen/DSF)
Time frame: Baseline and final assessment (3 months).
Change in Patient Health Questionnaire (PHQ-D)
Time frame: Baseline and final assessment (3 months).
Change in Pain sensitivity questionnaire (PSQ)
Time frame: Baseline and final assessment (3 months).
Change in Patient Global Impression of Improvement (PGI-I)
Time frame: Baseline and final assessment (3 months).
Change in Patient treatment satisfaction
Time frame: Baseline and final assessment (3 months).
Change in Treatment discomfort
Time frame: Twice after treatment, one and two months after baseline
Change in Treatment pain
Time frame: Twice after treatment, one and two months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erbium:Yag laser in people with Vulvodynia, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Vestibular pain index (time frame: Baseline and final assessment (3 months).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.