title: A long-term, multicenter, double-blind study of an Escherichia coli extract (OM-89) in female patients with recurrent urinary tract infections.
abstract: OBJECTIVE
  To investigate the long-term preventive effect of the immunotherapeutic OM-89 versus placebo in uncomplicated recurrent UTI in a large cohort of female patients only.
  
  
  METHODS
  Adult female patients could enroll in this multicenter, double-blind study if they had acute UTI at the enrollment visit and positive results of urinalysis (> or =10(3)bacteria/ml). Patients received the immunotherapeutic OM-89 or a matching placebo; 1 capsule per day for 90 days, 3 months without treatment, then the first 10 days in Months 7, 8 and 9 and were followed up during 12 months. Primary efficacy criteria were UTI rates over 12 months, distribution of UTIs and proportion of patients with UTI.
  
  
  RESULTS
  A total of 453 patients were treated, 231 in the active group and 222 in the placebo group. Mean rate of post-baseline UTIs was significantly lower in the active group than in the placebo group (0.84 vs. 1.28; p<0.003), corresponding to a 34% reduction of UTIs in patients treated with OM-89. In the active group, 93 patients (40.3%) had 185 post-baseline UTIs, compared to 276 UTIs in 122 patients (55.0%) in the placebo group (p=0.001). The safety profile of OM-89 was good and consistent with that reported in previous studies.
  
  
  CONCLUSIONS
  OM-89 significantly reduced the incidence of UTI during the 12 months of the study including 3 months of treatment and three 10-day booster courses. These results confirm that OM-89 is a valuable component of the management of recurrent UTI.
authors.affiliation: Maximilianstrasse 31, D-80539 Munich, Germany.
authors.forename: Hartwig W
authors.initials: HW
authors.lastname: Bauer
authors.forename: Schanaz
authors.initials: S
authors.lastname: Alloussi
authors.forename: Günther
authors.initials: G
authors.lastname: Egger
authors.forename: Hans-Martin
authors.initials: HM
authors.lastname: Blümlein
authors.forename: Gabriel
authors.initials: G
authors.lastname: Cozma
authors.forename: Claude C
authors.initials: CC
authors.lastname: Schulman
mesh_terms: D000328:Adult; D045424:Complex Mixtures / Q000627:therapeutic use*; D004311:Double-Blind Method; D004926:Escherichia coli; D006801:Humans; D007167:Immunotherapy; D012008:Recurrence; D013997:Time Factors; D014552:Urinary Tract Infections / Q000188:drug therapy* / Q000517:prevention & control*
chemical_list: D045424:Complex Mixtures