A long-term, multicenter, double-blind study of an Escherichia coli extract (OM-89) in female patients with recurrent urinary tract infections.
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.
Bauer
Hartwig W
HW
Maximilianstrasse 31, D-80539 Munich, Germany.
Alloussi
Schanaz
S
Egger
Günther
G
Blümlein
Hans-Martin
HM
Cozma
Gabriel
G
Schulman
Claude C
CC
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*
D045424:Complex Mixtures