Provoked vestibulodynia (PVD), a leading subtype of chronic pelvic pain, is characterized by pain at the vaginal entry with pressure or attempted vaginal penetration. Women with PVD are confronted with limited effective treatment options. High-intensity laser therapy (HILT) appears promising to fill this therapeutic gap based on pilot and feasibility studies [1,2]. Given the growing popularity of laser therapy, leading societies, including the International Continence Society, have emphasized the urgent need for high-quality evidence supporting its use. [3]. No randomized controlled trial (RCT) has yet investigated the efficacy of laser among women with PVD. The aim of this study was therefore to determine the efficacy of active HILT, compared to sham, in reducing pain during intercourse in women with PVD. Secondary objectives were to compare the effects of active and sham HILT on pain quality, sexual function and distress, satisfaction and perceived change.

This multicenter parallel-group RCT was conducted in women diagnosed with PVD following a standardized gynecological examination. Participants had to report pain (≥5/10, numerical rating scale [NRS]) at the vaginal entry during intercourse for >3 months. Participants were randomized (1:1) to either active or sham HILT sessions bi-weekly for 6 weeks. The active group was treated with the non-ablative Laser Fotona (Nd:Yag 1064nm) while the sham group received the same treatment regimen using a deactivated probe. Participants were evaluated at baseline, 2-week post-treatment, and 6-month follow-up using validated questionnaires. Patients, outcome assessors, and data analysts were blinded to group assignment. The primary outcome was pain intensity during intercourse (0–10 NRS). Secondary outcomes included pain quality (McGill–Melzack Pain Questionnaire), sexual function (Female Sexual Function Index), sexual distress (Female Sexual Distress Scale–Revised), satisfaction (0–10 NRS), and perceived change (Patient Global Impression of Change). The a priori sample size calculation determined that a total of 142 participants were required to detect a clinically significant difference of 1.5 points between groups (SD2.5; α=0.05; β=0.90), while accounting for a 15% dropout rate. Intention-to-treat analyses were conducted using linear growth models (considering between-group slope differences baseline–post-treatment and baseline–follow-up), t-tests and Fisher’s exact tests.

A total of 145 participants were allocated to the active (73) or the sham (72) group. Among these, 137 (94%) completed the post-treatment evaluation, and 134 (92%) the follow-up evaluation. Regarding pain intensity, although both groups showed changes from baseline to post-treatment, no clinically and statistically significant differences were found between groups at post-treatment (mean difference between groups -0.7 [95%CI -1.4 ; 0.0], slope difference p=0.383) and at follow-up (mean difference between groups -0.5 [95%CI -1.2 ; 0.2], slope difference p=0.630). Similarly, no between-group differences were observed in pain quality, sexual function, or sexual distress at post-treatment or follow-up (p≥0.163). Treatment satisfaction was slightly higher in the active group at post-treatment (active 6.3±2.8 vs sham 5.0±3.2; p=0.015), with no differences at follow-up (5.0±3.2 vs 4.5±3.5; p=0.365). Perceived change did not differ between groups: at post-treatment, 47% active vs 31% sham (p=0.057), and at follow-up, 30% vs 31% (p=0.139), reported being “much” or “very much” improved.

This is the first study investigating HILT in women with PVD. Results showed that active HILT did not significantly differ from sham in reducing pain during intercourse or improving secondary outcomes. Post-treatment satisfaction was slightly higher in the active group than in the sham group, but the difference was not sustained at follow-up.

Findings of this RCT show that active HILT was not effective, compared to sham, to reduce pain during intercourse in women with PVD.

Starzec-Proserpio M, Bardin MG, Morin M. Not all lasers are the same: a scoping review evaluating laser therapy for vulvodynia. Sex Med Rev. 2023 Dec 23;12(1):14-25.
Morin M, Paré J, Bérubé-Lauzière Y, Simard C, Tu LM. Feasibility, acceptability and effects of high intensity laser therapy for women with vulvodynia: a randomized prospective pilot study. Continence. 2022 Jun 01;2S2.
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