Lasertherapy for Vulvodynia

NCT ID: NCT04711369

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2026-07-30

Brief Summary

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

Conditions

Vulvodynia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention group (laser therapy)

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.

Group Type: ACTIVE_COMPARATOR

Erbium:Yag laser

Intervention Type: DEVICE

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.

Control group (sham laser therapy)

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.

Group Type: SHAM_COMPARATOR

Sham Erbium:Yag laser

Intervention Type: DEVICE

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.

Interventions

Erbium:Yag laser

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.

Intervention Type: DEVICE

Sham Erbium:Yag laser

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Obstetrics and Gynecology/ Medical University of Graz

Graz, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Gerda Trutnovsky, MD

Role: CONTACT

gerda.trutnovsky@medunigraz.at

+43 316 385 ext. 81081

Karl Tamussino, MD

Role: CONTACT

karl.tamussino@medunigraz.at

+43 316 385 ext. 81068

Facility Contacts

Gerda Trutnovsky, MD

Role: primary

gerda.trutnovsky@medunigraz.at

+43 316 385 ext. 81081

Daniela Gold, MD

Role: backup

daniela.gold@medunigraz.at

+43 316 385 ext. 81437

Other Identifiers

32-187 ex 19/20

Identifier Type: -

Identifier Source: org_study_id