Four New Studies Support the Use of Non-ablative Fotona SMOOTH® Technology for SUI

29 December 2025

Global Clinical Evidence continues to support the use of Er:YAG laser for Stress Urinary Incontinence. Read the four most recent studies on the effectiveness of the revolutionary non-ablative Fotona SMOOTH® technology.

Large Prospective Sham-Controlled Trial Confirms Efficacy and Safety

Wang et al. reported results from a prospective, multicenter randomized trial involving 126 women with mild-to-moderate SUI. Three sessions of non-ablative vaginal Er:YAG laser therapy resulted in a 71.4% treatment success rate at 3 months—nearly double that of the sham group. Objective improvements in urine leakage were accompanied by a favorable safety profile, positioning laser therapy as a promising non-surgical alternative for appropriately selected patients.

 https://doi.org/10.1007/s10103-025-04400-3

Randomized Evidence Supporting Vaginal Er:YAG Laser vs. Sham

Phillips et al. conducted a multicenter, randomized, sham-controlled trial in women with mild-to-moderate SUI. At 6 months, 62.7% of women treated with vaginal Er:YAG laser achieved “cure” (≥50% reduction in pad weight), compared with just 18.2% in the sham group. Significant improvements were also observed in incontinence severity and sexual function, reinforcing the clinical relevance of this non-ablative approach.

https://doi.org/10.1111/1471-0528.70080

Enhancing Outcomes by Combining Intraurethral and Vaginal Laser Therapy

Erel et al. compared intraurethral Er:YAG laser treatment alone with a combined intraurethral + intravaginal approach in women with SUI or stress-dominant mixed urinary incontinence. While both treatments significantly improved symptoms up to 12 months, the combined approach produced a steeper and more pronounced reduction in ICIQ-UI SF scores over time. These real-world, multicenter data suggest that addressing both urethral and vaginal support structures may optimize long-term outcomes.

 https://doi.org/10.1007/s10103-025-04691-6

Meaningful Quality-of-Life Gains After IncontiLase® Treatment

Pancholia et al. evaluated patient-reported outcomes following non-ablative Er:YAG laser treatment (IncontiLase®) in women with SUI. As early as 2 months post-treatment, participants reported marked improvements in symptom burden and quality of life, with continued gains at 9 months. Importantly, symptoms were no longer considered bothersome enough to seek further care—highlighting the real-world impact of laser therapy beyond objective measures.

https://doi.org/10.1155/aiu/1255593

These recent peer-reviewed studies show significant, clinically meaningful improvements in patient-reported quality of life after non-ablative Er:YAG laser treatment for SUI.

Real Clinical Evidence. Real Quality-of-Life Improvements. Fotona SMOOTH®