Lasertherapy for Vulvodynia

NCT04711369 | Recruiting

• 1 other identifier: 32-187 ex 19/20
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to assess the efficacy, acceptance and safety profile of vulvovaginal laser therapy in women with vulvodynia.

Conditions

Vulvodynia

Keywords

Erbium:Yag laser

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline and final assessment (3 months).

Secondary Outcomes (16)

• Change of pelvic floor muscle (PFM) function- PFM contraction strength

  Baseline and final assessment (3 months).

• Change of pelvic floor muscle (PFM) function- PFM tone

  Baseline and final assessment (3 months).

• Change of levator hiatal dimensions at rest

  Baseline and final assessment (3 months).

• Change of levator hiatal dimensions at maximal voluntary contraction

  Baseline and final assessment (3 months).

• Change of levator hiatal dimensions at maximal Valsalva maneuver

  Baseline and final assessment (3 months).

Study Arms (2)

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.

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.

Device: Sham Erbium:Yag laser

Interventions

Erbium:Yag laser 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.

Intervention group (laser therapy)

Sham Erbium:Yag laser 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.

Control group (sham laser therapy)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with vulvodynia (diagnosed according to the 2015 Consensus Terminology)
• multidisciplinary treatment for at least 3 months
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Department of Obstetrics and Gynecology/ Medical University of Graz

Graz, 8036, Austria

RECRUITING

MeSH Terms

Conditions

Vulvodynia

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Gerda Trutnovsky, MD

CONTACT

+43 316 385; gerda.trutnovsky@medunigraz.at

Karl Tamussino, MD

CONTACT

+43 316 385; karl.tamussino@medunigraz.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sham-controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized double blinded sham-controlled clinical study

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: January 15, 2021
• Study Start: January 15, 2021
• Primary Completion: January 15, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: March 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)