title: A prospective multi-center trial of Escherichia coli extract for the prophylactic treatment of patients with chronically recurrent cystitis.
abstract: 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.
authors.affiliation: Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Kun Suk
authors.initials: KS
authors.lastname: Kim
authors.forename: Ji-Yoon
authors.initials: JY
authors.lastname: Kim
authors.forename: In Gab
authors.initials: IG
authors.lastname: Jeong
authors.forename: Jae-Seung
authors.initials: JS
authors.lastname: Paick
authors.forename: Hwancheol
authors.initials: H
authors.lastname: Son
authors.forename: Dae Jung
authors.initials: DJ
authors.lastname: Lim
authors.forename: Hong Bang
authors.initials: HB
authors.lastname: Shim
authors.forename: Won Hee
authors.initials: WH
authors.lastname: Park
authors.forename: Hee Chang
authors.initials: HC
authors.lastname: Jung
authors.forename: Myung-Soo
authors.initials: MS
authors.lastname: Choo
mesh_terms: 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
chemical_list: D002457:Cell Extracts