A prospective multi-center trial of Escherichia coli extract for the prophylactic treatment of patients with chronically recurrent cystitis.
We have assessed the efficacy and safety of Escherichia coli extract (ECE; Uro-Vaxom) which contains active immunostimulating fractions, in the prophylactic treatment of chronically recurrent cystitis. Forty-two patients with more than 2 episodes of cystitis in the proceeding 6 months were treated for 3 months with one capsule daily of ECE and observed for a further 6 months. The primary efficacy criterion was the number of episodes of recurrent cystitis during the 6 months after treatment compared to those during the 6 months before treatment. At the end of the 9-month trial, 34 patients (all women) were eligible for statistical analysis. Their mean age was 56.4 yr (range, 34-75 yr), and they had experienced recurrent urinary tract infections for 7.2+/-5.2 yr. The number of recurrences was significantly lower during the 6-month follow-up period than during the 6 months preceding the trial (0.35 vs. 4.26, P<0.001). During the follow-up, 28 (82.4%) patients had no recurrences and 4 (11.8%) had 1 each. In patients who relapsed, ECE alleviated cystitis symptoms, including painful voiding, frequency and urgency. There were no serious adverse events related to the study drug. Our study demonstrates the efficacy and safety of ECE in the prophylactic treatment of chronically recurrent cystitis.
Kim
Kun Suk
KS
Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Kim
Ji-Yoon
JY
Jeong
In Gab
IG
Paick
Jae-Seung
JS
Son
Hwancheol
H
Lim
Dae Jung
DJ
Shim
Hong Bang
HB
Park
Won Hee
WH
Jung
Hee Chang
HC
Choo
Myung-Soo
MS
D000328:Adult; D000368:Aged; D002457:Cell Extracts / Q000276:immunology / Q000627:therapeutic use*; D003556:Cystitis / Q000188:drug therapy* / Q000276:immunology / Q000382:microbiology / Q000517:prevention & control*; D004926:Escherichia coli / Q000737:chemistry* / Q000276:immunology / Q000472:pathogenicity; D005260:Female; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies; D012008:Recurrence
D002457:Cell Extracts