Low Intensity Extracorporeal Shock Wave Therapy as a Novel Treatment for Stress Urinary Incontinence: A Randomized-Controlled Clinical Study

Aims: To evaluate the effects of low intensity extracorporeal shock wave therapy (LiESWT) on stress urinary incontinence (SUI). Methods: This investigation was a multicenter, single-blind, randomized controlled trial study. 60 female SUI patients were randomly assigned to receive LiESWT with 0.25 mJ/mm2 intensity, 3000 pulses, and 3 pulses/second, once weekly for 4-week (W4) and 8-week (W8), or an identical sham LiESWT treatment without energy transmission. The primary endpoint was the changes in urine leakage as measured by pad test and validated standardized questionnaires. While the secondary endpoint was the changes in 3-day urinary diary among the baseline (W0), the W4 and the W8 of LiESWT, and 1-month (F1), 3-month (F3) and 6-month (F6) follow-up after LiESWT. Results: The results showed that 4-week LiESWT could significantly decrease urine leakage based on pad test and validated standardized questionnaire scores, as compared to the sham group. Moreover, 4-week LiESWT could significantly reduce urine leakage, but increase urine volume and attenuate urgency symptom, which showed meaningful and persistent improvement at W8, F1, F3 and F6. Furthermore, validated standardized questionnaire scores were significantly improved at W4, W8, F1, F3 and F6 as compared to the baseline (W0). Conclusions: 8-week LiESWT could attenuate SUI symptoms on physical activity, reduce urine leakage and ameliorate overactive bladder symptoms, which implied that LiESWT significantly improved the quality of life. Our findings suggested that LiESWT could serve as a potentially novel and non-invasive treatment for SUI.