Chuang YC. et al., 2020: 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
Chuang YC, Meng E, Chancellor M, Kuo HC.
Department of Urology, Center for Shockwave Medicine and Tissue Engineering, Kaohsiung Chang Gung Memorial Hospital, College of Medicine, Chang Gung University, Taoyuan City, Taiwan.
Division of Urology, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.
Department of urology, Oakland University William Beaumont School of
Department of Urology, Hualien Tzu Chi General Hospital, Tzu Chi Medical Foundation, Buddhist Tzu Chi University, Hualien, Taiwan.
Abstract
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.
Neurourol Urodyn. 2020 Jun;39(5):1505-1514. doi: 10.1002/nau.24382. Epub 2020 May 11. PMID: 32394478
Comments 1
Interstitial cystitis is a pathological condition associated with intolerable pain and frequency. Clinically, it might be demanding and challenging to give these patients satisfactory relief of symptoms. It therefore is of interest to note that ESWT resulted in at least some improvement.
Although both groups in this study experienced decreased symptom scores, it is noteworthy that in patients with initial pain-score of ≥3, ESWT reduced the pain in 57.1% compared with 19% in the placebo-treated group. The frequency was numerically but not statistically reduced.
It might thus be worthwhile to try ESWT in patients with severe symptoms caused by interstitial cystitis/bladder pain syndrome.
The equipment used was a Taiwan system (Lithomed LM) with which 2000 weekly shockwaves were given during a period of 4 weeks. SW-frequency 3 Hz and energy density 0.25 mJ/ mm2.
Hans-Göran Tiselius