NCT04711369

Lasertherapy for Vulvodynia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.
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.

Timeline

• Start date: 2021-01-15
• Primary completion: 2026-01-15
• Completion: 2026-07-30
• First posted: 2021-01-15
• Last updated: 2025-03-04

Locations

1 site across 1 country: Austria