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.
Neurourol Urodyn
; 39(5): 1505-1514, 2020 06.
Article
em En
| MEDLINE
| ID: mdl-32394478
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.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Micção
/
Cistite Intersticial
/
Manejo da Dor
/
Tratamento por Ondas de Choque Extracorpóreas
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
/
Etiology_studies
/
Observational_studies
/
Risk_factors_studies
Limite:
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article