Efficacy and safety of skin-adhesive low-level light therapy for overactive bladder: a Phase III study

Introduction and hypothesis Overactive bladder (OAB) is a common condition that remains challenging to treat. We hypothesized that skin-adhesive low-level light therapy (LLLT) would be an effective treatment for OAB caused by bladder muscle contraction. Accordingly, we aimed to evaluate the efficacy and safety of an LLLT device for the treatment of OAB. Methods This prospective, randomized, double-blind, placebo-controlled, multicenter trial included patients with a clinical diagnosis of OAB who were treated at either of two university hospitals. Patients were instructed to apply an LLLT device (Color DNA-WSF) or a sham device at home three times daily for 12 weeks. The primary outcome was the change in the mean daily number of urge urinary incontinence (UUI) episodes between baseline and 12 weeks. The secondary outcomes were the mean changes in incontinence, voiding, and nocturia episodes from baseline and the likelihood of achieving a > 50% reduction in UUI and incontinence episodes after 12 weeks. All patients completed the Overactive Bladder Symptom Score (OABSS), Urogenital Distress Inventory-6 (UDI-6), and Impact Urinary Incontinence-7 (IIQ-7) questionnaires. Safety parameters included treatment-emergent adverse events. Results Compared with those in the sham group, the numbers of UUI and urinary incontinence episodes in the LLLT group were significantly decreased at week 12 (UUI, (-1.0 +/- 1.7 vs. -0.4 +/- 2.5, P = 0.003; urinary incontinence, -1.1 +/- 1.9 vs. -0.5 +/- 2.9, P=0.002). Furthermore, the OABSS, UDI-6, and IIQ-7 scores at week 12 tended to be better in the LLLT group than in the sham group. The incidence of device-related treatment-emergent adverse events was similar between groups. Conclusions LLLT may be clinically useful and safe for the treatment of OAB.

Automated summary

This study aimed to evaluate the efficacy and safety of low-level light therapy (LLLT) device for the treatment of overactive bladder (OAB). The results showed that compared to the sham group, the LLLT group had significantly reduced episodes of urge urinary incontinence (UUI) and urinary incontinence after 12 weeks of treatment, and LLLT also tended to improve the OAB symptoms and quality of life. This study suggests that LLLT may be a safe and effective treatment for OAB.