The efficacy and safety of a single maintenance laser treatment for stress urinary incontinence: a double-blinded randomized controlled trial

INTRODUCTION AND HYPOTHESIS: To evaluate the efficacy and safety of a single carbon dioxide (CO(2)) laser maintenance treatment in women previously treated successfully with laser for stress urinary incontinence (SUI), who have demonstrated a decline in treatment effect. METHODS: Women aged 40–70 years who experienced temporary significant improvement in symptoms following CO(2) laser treatments for SUI were randomized to either the treatment group or the sham treatment control group. Cough test results, 1-h pad weights and scores on the Urogenital Distress Inventory (UDI6), the International Consultation of Incontinence Questionnaire (ICIQ-UI) and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) were obtained at baseline and 3 and 6 months. RESULTS: Of 183 women screened, 131 were included in the final analysis. Demographic characteristics and baseline measures in the outcome tests were similar between the groups. Statistically significant improvements were demonstrated in the study compared to the control group at 3 months post-treatment in positive cough test (44.4% vs. 79.4%, P = 0.002), mean pad weight test (2.3 g ± 1.3 vs. 5.6 ± 1.1, P < 0.001), mean UDI-6(24.7 ± 12.1 vs. 45.1 ± 13.6 SD, P = 0.004), mean ICIQ-UI (16.5 ± 4.3 vs. 10.3 + 3.8, P = 0.003) and mean PISQ-12 (21.3 ± 6.8 vs. 36.6 ± 7.5, P = 0.003). However, values at 6 months post-treatment were similar to those at baseline. CONCLUSIONS: Our results suggest that a single maintenance laser treatment for reducing symptoms of SUI is transiently effective, well tolerated and safe. This treatment modality provides alternative non-surgical therapy for women with SUI.