Vaginal erbium laser treatment for stress urinary incontinence: A multicenter randomized sham‐controlled clinical trial

Abstract

ObjectiveTo evaluate the efficacy and safety of non‐ablative vaginal Er:YAG laser device in stress urinary incontinence (SUI) treatment.MethodsWe conducted a multicenter blinded randomized sham‐controlled trial in which women with urodynamic SUI were randomization to active arm using Er:YAG laser therapy, and sham arm using sham handpiece. Patients received two treatments 1 month apart. The primary outcomes measure was 1 h pad weight test measured at 6 months. Secondary outcomes were durability of treatment success at 12 months, and questionnaires for assessment of SUI severity (ICIQ‐UI SF), sexual function (PISQ‐12) and HRQoL (KHQ), and incidence and severity of device related adverse events and pain (VAS).ResultsA total of 110 participants with SUI were recruited; 73 in the active arm and 37 in the sham arm. Two participants were excluded; one was assigned the wrong treatment and one withdrew their consent. Treatment success was observed in 36% of the sham arm and 59% of the active arm; in the latter, odds of achieving treatment success were more than three‐fold higher (OR 3.63, 95% CI: 1.3–11.2, P = 0.02). HRQoL by KHQ showed significant improvement in the active versus the sham arm (OR 0.36, 95% CI: 0.15–0.87, P = 0.003). Similarly, subjective patient assessment of general and sexual function improvement with PISQ‐12 and PGI‐I showed superior effect over sham (OR 2.8, 95% CI: 1.2–7.0, P = 0.02 and OR 0.13, 95% CI: 0.05–0.36, P < 0.001, respectively).ConclusionNon‐ablative vaginal Er:YAG laser therapy significantly improves SUI symptoms versus sham treatment. Er:YAG laser therapy should be considered as a non‐surgical treatment option for SUI patients.

Mesh Extraction Surgery and Laser Treatment for Pain After Mid-Urethral Sling Surgery: A Case Series

“…Both VEL and UEL were well tolerated in our study, with no reported complaints from the patients, such as burning during urination or dysuria. Furthermore, there were no observed indications of a risk of urethral stricture associated with laser therapy, which is consistent with previous research [8][9][10][11][12][13][14]19,20].…”

“…Our selection consisted of the non-ablative erbium:yttrium-aluminum-garnet (Er:YAG) SMOOTH® laser, accompanied by a laser tailored for the vagina (vaginal erbium laser (VEL)) and the urethra (urethra erbium laser (UEL)). Previous reports showed that a combination of VEL and UEL improved severe SUI [8][9][10][11][12][13][14]. VEL itself is very 1 2 safe, with few side effects observed [12,14].…”

“…VEL and UEL employ a series of non-ablative micropulses to deliver heat penetration at depths of approximately 400-500 um, stimulating tissue regeneration, collagen formation, and blood vessel development. This process occurs without surface damage and has been observed to affect tissues up to 2 mm deep in the mucosa [8][9][10][11][12][13][14].…”

Innovative decision making tools using discrete mathematics for stress urinary incontinence treatment

“…Given modern ethical standards, this limitation becomes more complex when considering the difficulty of conducting randomized controlled trials (RCTs) that compare highly invasive procedures with less invasive alternatives given modern ethical standards. Recent studies reporting promising results for VEL suggest that it is a viable and minimally invasive treatment option 14 , 54 . However, the long-term efficacy and safety of this treatment need to be established through further high-quality longitudinal studies.…”

“…A common treatment is mid-urethral sling (MUS) procedures using polypropylene mesh, but this method can lead to postoperative pain, foreign body reactions, inflammation, and even the emergence or worsening of Urgency Urinary Incontinence (UUI) 11 – 13 . Given these issues, Vaginal Erbium Laser (VEL) therapy has gained attention as a non-ablation alternative 14 – 18 . However, owing to the lack of sufficient data, choosing between MUS and VEL remains challenging.…”