Abstract
Purpose: We wanted to investigate the efficacy and safety of the immunotherapeutic Uro-Vaxom for treating uncomplicated recurrent cystitis in female patients only. Materials and Methods: Adult female patients were enrolled in this multicenter, open-label study if they had acute cystitis at the enrollment visit and positive results on urine culture (≥103 CFU/ml). The patients were treated for 3 months with one capsule daily of Uro-Vaxom after antibiotic therapy, and they were observed for another 3 months. The primary efficacy criteria were the cystitis recurrence rates over 6 months, the distribution of cystitis and the proportion of patients with cystitis. Results: A total of 50 patients were evaluated. During the 6-month trial, the number of cystitis recurrences was significantly reduced in comparison with the 6-month pretrial period (on the average 0.64 as compared to 3.0 recurrences, respectively p < 0.001). The incidences of frequency, urgency and dysuria remained low until the end of the trial. Uro-Vaxom was well tolerated: side-effects were mentioned by 8% of the 50 patients, and there was no case leading to treatment withdrawal. Conclusions: Uro-Vaxom significantly reduced the incidence of cystitis during the 6 months of this study, including the 3 months of treatment. These results demonstrate that Uro-Vaxom is a valuable agent for prophylaxis of recurrent cystitis.
| Original language | English |
|---|---|
| Pages (from-to) | 428-432 |
| Number of pages | 5 |
| Journal | Korean Journal of Urology |
| Volume | 48 |
| Issue number | 4 |
| Publication status | Published - 2007 Apr 1 |
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Keywords
- Cystitis
- Escherichia coli
- Female
- Uro-Vaxom
ASJC Scopus subject areas
- Urology
Cite this
Efficacy and safety of uro-vaxom treatment for patients with recurrent cystitis : An open multicenter study. / Lee, Seung Ju; Kim, Su Jin; Cho, Yong Hyun; Woo, Young Nam; Kim, Bup Wan; Chang, Sung Goo; Kim, Min Eui; Kim, Chul Sung; Lee, Jeong Gu; Sim, Bong Suck; Kim, Hyung Jin; Chung, Byung Ha; Cho, In Rae; Lee, Sang Don.
In: Korean Journal of Urology, Vol. 48, No. 4, 01.04.2007, p. 428-432.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Efficacy and safety of uro-vaxom treatment for patients with recurrent cystitis
T2 - An open multicenter study
AU - Lee, Seung Ju
AU - Kim, Su Jin
AU - Cho, Yong Hyun
AU - Woo, Young Nam
AU - Kim, Bup Wan
AU - Chang, Sung Goo
AU - Kim, Min Eui
AU - Kim, Chul Sung
AU - Lee, Jeong Gu
AU - Sim, Bong Suck
AU - Kim, Hyung Jin
AU - Chung, Byung Ha
AU - Cho, In Rae
AU - Lee, Sang Don
PY - 2007/4/1
Y1 - 2007/4/1
N2 - Purpose: We wanted to investigate the efficacy and safety of the immunotherapeutic Uro-Vaxom for treating uncomplicated recurrent cystitis in female patients only. Materials and Methods: Adult female patients were enrolled in this multicenter, open-label study if they had acute cystitis at the enrollment visit and positive results on urine culture (≥103 CFU/ml). The patients were treated for 3 months with one capsule daily of Uro-Vaxom after antibiotic therapy, and they were observed for another 3 months. The primary efficacy criteria were the cystitis recurrence rates over 6 months, the distribution of cystitis and the proportion of patients with cystitis. Results: A total of 50 patients were evaluated. During the 6-month trial, the number of cystitis recurrences was significantly reduced in comparison with the 6-month pretrial period (on the average 0.64 as compared to 3.0 recurrences, respectively p < 0.001). The incidences of frequency, urgency and dysuria remained low until the end of the trial. Uro-Vaxom was well tolerated: side-effects were mentioned by 8% of the 50 patients, and there was no case leading to treatment withdrawal. Conclusions: Uro-Vaxom significantly reduced the incidence of cystitis during the 6 months of this study, including the 3 months of treatment. These results demonstrate that Uro-Vaxom is a valuable agent for prophylaxis of recurrent cystitis.
AB - Purpose: We wanted to investigate the efficacy and safety of the immunotherapeutic Uro-Vaxom for treating uncomplicated recurrent cystitis in female patients only. Materials and Methods: Adult female patients were enrolled in this multicenter, open-label study if they had acute cystitis at the enrollment visit and positive results on urine culture (≥103 CFU/ml). The patients were treated for 3 months with one capsule daily of Uro-Vaxom after antibiotic therapy, and they were observed for another 3 months. The primary efficacy criteria were the cystitis recurrence rates over 6 months, the distribution of cystitis and the proportion of patients with cystitis. Results: A total of 50 patients were evaluated. During the 6-month trial, the number of cystitis recurrences was significantly reduced in comparison with the 6-month pretrial period (on the average 0.64 as compared to 3.0 recurrences, respectively p < 0.001). The incidences of frequency, urgency and dysuria remained low until the end of the trial. Uro-Vaxom was well tolerated: side-effects were mentioned by 8% of the 50 patients, and there was no case leading to treatment withdrawal. Conclusions: Uro-Vaxom significantly reduced the incidence of cystitis during the 6 months of this study, including the 3 months of treatment. These results demonstrate that Uro-Vaxom is a valuable agent for prophylaxis of recurrent cystitis.
KW - Cystitis
KW - Escherichia coli
KW - Female
KW - Uro-Vaxom
UR - http://www.scopus.com/inward/record.url?scp=34247882728&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=34247882728&partnerID=8YFLogxK
M3 - Article
AN - SCOPUS:34247882728
VL - 48
SP - 428
EP - 432
JO - Korean Journal of Urology
JF - Korean Journal of Urology
SN - 2005-6737
IS - 4
ER -