Study design, materials and methods
From May 2019 to December 2023, a total of 119 female patients diagnosed with mild to moderate stress urinary incontinence (SUI) were enrolled in this study. Diagnosis of mild to moderate SUI was based on each patient's urodynamic study. Participants were divided into treatment groups based on patient preference: 85 patients received a course of three vaginal laser treatments alone, while 34 patients underwent both three vaginal laser treatments and pelvic floor muscle training (PFMT). Among the latter group, 16 patients received laser treatment first, followed by PFMT, while 18 patients underwent PFMT before receiving laser treatment. The vaginal laser treatment was performed using the fractional CO2 laser system (SmartXide2 V²LR, MonaLisa Touch; DEKA, Florence, Italy) and each patient underwent three treatments with intervals of four weeks between each treatment. The PFMT program consisted of an individualized comprehensive rehabilitation plan, incorporating pelvic floor exercises with biofeedback and electrical stimulation, as well as lifestyle modifications and behavioral therapy. Treatment outcomes were assessed using the Female Sexual Function Index (FSFI), the Visual Analog Scale (VAS), and the Urogenital Distress Inventory-6 (UDI-6) questionnaire. Patients were assessed at baseline, 1-, 6-, and 12-month follow-ups. Statistical analysis was performed to compare outcomes between the laser-only group and the laser with PFMT group, assessing differences in sexual function, pain levels, and urinary distress.
Results
There were no significant differences in the patient characteristics between the two groups (Table 1). In both the laser-only group and the laser with PFMT group, there was a statistically significant change in the UDI-6 scores at 1-, 6-, and 12-month post-treatment follow-ups when compared to baseline (Table 1). Furthermore, there was a statistically significant improvement in both FSFI total and domain scores at follow-up when compared to baseline in both groups (Figure 1). The one-month, six-month, and twelve-month improvement of total FSFI score compared to baseline in the laser only group was 18.2%, 27.8%, and 27.5%, respectively, and in the laser with PFMT group was 26.8%, 27.9% and 27.7%, respectively. Between-group analysis did not show any statistically significant differences in baseline and follow-up scores in both FSFI and UDI-6 questionnaires. Patients’ satisfaction with vaginal laser treatment was 90%.
Interpretation of results
Vaginal laser therapy is an effective and noninvasive procedure that restores vaginal health, increases collagen deposits, and increases submucosal vascularity in vaginal tissue. The present study evaluated the short-term and long-term efficacy of vaginal laser treatment and vaginal laser with PFMT on sexual function and urinary incontinence. The results showed statistically significant improvement in the assessment of incontinence and sexual function symptoms via the UDI-6, VAS, and FSFI questionnaires at one-month follow-up and these improvements were sustained for at least one-year post-treatment in both the laser-only and the laser with PFMT groups. However, there was no statistically significant difference in questionnaire scores between groups. These findings indicate that while both treatment approaches are effective, the therapeutic effect of CO₂ vaginal laser alone is not inferior to the combined vaginal laser treatment with PFMT. Furthermore, patient satisfaction with the vaginal laser therapy is high.