Improves symptoms and urinary biomarkers in refractory interstitial cystitis/bladder pain syndrome patients randomized to extracorporeal shock wave therapy versus placebo

Yuan-Chi Shen,Pradeep Tyagi,Michael Chancellor,Wei-Chia Lee,Yao-Chi Chuang

doi:10.1038/s41598-021-87040-1

Abstract

Extracorporeal shock wave therapy (ESWT) has been shown to improve symptoms in patients with interstitial cystitis/bladder pain syndrome (IC/BPS); however, there is a lack of objective evidence. We measured change of urinary biomarker levels in 25 patients with IC/BPS received ESWT or placebo once a week for 4 weeks. Urines were collected from participants at baseline, 4 and 12 weeks post treatment. A representative 41 inflammatory growth factors, cytokines, and chemokines in urine were measured using a MILLIPLEX immunoassay kit. Symptom bother was assessed by O’Leary-Sant symptom scores (OSS), and visual analog scale (VAS) for pain. The ESWT group exhibited a significant reduction in the OSS and VAS compared to the placebo group 4 weeks post-treatment (P < 0.05), and the effects were persistent at 12 weeks. The difference in urinary markers change in ESWT versus placebo was P = 0.054 for IL4, P = 0.013 for VEGF, and P = 0.039 for IL9 at 4 weeks. The change of urine biomarker was not significant in other biomarkers or all the measured proteins at 12 weeks. The current data suggest that IL4, IL9, and VEGF mediation may be involved in its pathophysiologic mechanisms and response to LESW treatment.

Highlights

Extracorporeal shock wave therapy (ESWT) has been shown to improve symptoms in patients with interstitial cystitis/bladder pain syndrome (IC/BPS); there is a lack of objective evidence
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic disease characterized by symptoms of unpleasant sensation, pain, pressure, and discomfort perceived to be related to the urinary bladder, associated with lower urinary tract symptoms, in the absence of infection or other identifiable c auses[1]
The final intent-to-treat population consisted of 24 subjects, including 13 in ESWT, and 11 in placebo groups of whom all subjects completed the primary endpoint evaluation (i.e. 4 weeks post-treatment)

Summary

Introduction

Extracorporeal shock wave therapy (ESWT) has been shown to improve symptoms in patients with interstitial cystitis/bladder pain syndrome (IC/BPS); there is a lack of objective evidence. We measured change of urinary biomarker levels in 25 patients with IC/BPS received ESWT or placebo once a week for 4 weeks. The ESWT group exhibited a significant reduction in the OSS and VAS compared to the placebo group 4 weeks post-treatment (P < 0.05), and the effects were persistent at 12 weeks. Low energy shock wave (LESW), known to exert anti-inflammatory, anti- apoptotic effects, and improve tissue repair, has been applied for the treatment of urological disease, including erectile dysfunction, and chronic prostatitis chronic pelvic pain syndrome[5,6]. Towards that end we assessed the change in urine levels of multiple growth factors, cytokines, chemokines, and clinical symptoms of IC/BPS patients at baseline and after LESW or placebo treatment

Objectives

Methods

Results