Pain reduction realized with extracorporeal shock wave therapy for the treatment of symptoms associated with interstitial cystitis/bladder pain syndrome—A prospective, multicenter, randomized, double‐blind, placebo‐controlled study

• Published in: Neurourology and urodynamics Vol. 39; no. 5; pp. 1505 - 1514
• Main Authors: Chuang, Yao‐Chi, Meng, En, Chancellor, Michael, Kuo, Hann‐Chorng
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01.06.2020
• Subjects: Bladder; bladder pain syndrome; Cystitis; Cystitis, Interstitial - complications; Cystitis, Interstitial - physiopathology; Cystitis, Interstitial - therapy; Double-Blind Method; Double-blind studies; Energy flow; Extracorporeal Shockwave Therapy; Female; Humans; interstitial cystitis; Lithotripsy; Male; Middle Aged; Pain; Pain - etiology; Pain - physiopathology; Pain Management; Pain Measurement; Patient Satisfaction; Prospective Studies; shock wave; Statistical analysis; Treatment Outcome; Urination - physiology; shock wave; bladder pain syndrome; interstitial cystitis
• ISSN: 0733-2467; 1520-6777; 1520-6777
• DOI: 10.1002/nau.24382

Aims Extracorporeal shock wave therapy (ESWT) inhibited bladder inflammation and pain in preclinical studies. We assessed ESWT for the treatment of refractory interstitial cystitis/bladder pain syndrome (IC/BPS). Methods This double‐blind, randomized, placebo‐controlled physician‐initiated study enrolled 54 patients with IC/BPS. The patients were assigned to ESWT (N = 24; 2000 shocks, frequency of 3 Hz, and maximum total energy flow density 0.25 mJ/mm2) once a week for 4 weeks at suprapubic bladder area or placebo (N = 25; shock wave setting without energy transmission). The primary endpoint was the average changes in O'Leary‐Sant symptom scores (OSS) between baseline and 4 weeks after treatment. Secondary endpoints included visual analog scale (VAS, 0‐10) for pain, the average changes of variables in a 3‐day voiding diary, and global response assessment of patient satisfaction. Results At 4 weeks posttreatment, both groups were associated with a statistically significant decrease in OSS and VAS pain scale. However, there were no difference in mean change between ESWT vs placebo groups. A significantly higher proportion of patients on ESWT responded as improved in the VAS ≥ 3 vs placebo (P = .035). At 12 weeks posttreatment, improvement in the VAS ≥ 3 was 57.1% vs 19.0% (ESWT vs placebo; P = .011). The finding was associated with an improvement in frequency − 1.0 ± 2.3 vs 0.7 ± 3.2 (ESWT vs placebo; P = .065). No significant adverse events were found in either group. Conclusions A reduction in pain was discovered in this trial assessing ESWT in patients with IC/BPS but OSS, which was the primary outcome parameter, was not improved.