Session I Y. Kawada
inclusion Criteria for Acute Uncomplicated Cystitis Patients and Methods Summary: Inclusion criteria for acute uncomplicated cystitis were studied in a total of 307 patients. The data on recurrence should be grouped according to age or menopause, because recurrence was observed only in postmenopausal patients, and the mean age was significantly higher in the recurrence group than in the non-recurrence group. Bacteriuria of 103 and 104 cfu/ml could be included only when urine was collected by catheterization or very careful clean-catch method, because the incidence of uropathogens was significantly low even in patients with bacteriuria of 104 cfu/ml, when urine was collected by conventional midstream catch. Zusammenfassung: Einschluflkriterien far die akute Zystitis. Die Einschlugkriterien fiir die akute unkomplizierte Zystitis wurden bei insgesamt 307 Patientinnen fiberprtift. Die H/iufigkeit rezidivierender Zystitiden sollte nach dem Alter oder dem Zeitpunkt der Menopause eingeteilt werden, da Rezidive nur bei Frauen in der Menopause auftraten und das mittlere Alter in der Gruppe mit Rezidiven hfher als in der Gruppe ohne Rezidive war. Eine Bakteriurie mit einer Keimzahl yon 103/ml und 104/ml sollte nur dann als Einschluf3kriterium gelten, wenn der Urin mittels Einmalkatheterismus oder mittels sorgf/iltiger Mittelstrahltechnik nach vorheriger Reinignng (clean catch) gewonnen wurde. Bei Verwendung der fiblichen Mittelstrahltechnik fanden sich bei diesen Keimzahlen nur bei wenigen Patientinnen uropathogene Erreger, selbst wenn die Keimzahl bei 104/ml lag.
Introduction According to the inclusion criteria for acute uncomplicated cystitis on which an agreement was reached at the First International Symposium on Clinical Evaluation of Drug Efficacy in UTI held in Tokyo in October 1989, only female patients over 16 years of age with pain on micturition, urinary frequency or sense of residual urine, pyuria of at least 10 leucocytes per high power microscopic field (HPF) and bacteriuria of at least 103 colony forming unit (CFU) per ml of urine are to be included in the study for evaluating the clinical efficacy and safety of antimicrobial agents for acute uncomplicated cystitis [1]. The duration of symptoms from onset and upper age limit are not fixed in these criteria. In this paper, the practicability of these criteria was studied.
The study population consisted of a total of 307 female patients
from seven different institutions in Japan who met the above criteria and who were shown to have no underlying urinary tract disease. Patients were treated with either oral sparfloxacin (100 mg once daily) or enoxacin (100 mg t.i.d.) for three or seven days. The background characteristics of all patients were analyzed. Clinical efficacy was evaluated in 202 patients by the criteria proposed by the Japanese UTI Committee as excellent, moderate or poor based on the combination of changes in symptoms, pyuria and bacteriuria [2]. Recurrence was checked in 104 patients seven to ten days after completion of treatment. Patients with pyuria of 10 leucocytes/HPF or more and bacteriuria of 104 cfu/ml or more after completion of treatment were assessed a s "recurrence."
Results The ages of 307 patients ranged from 17 to 78 years with an almost equal distribution between 20 and 60. Consequently, 44.3% of the patients were postmenopausal. Excellent and moderate responses were obtained in 200 (99.0%) of 202 patients. No significant differences were observed between premenopausal and postmenopausal patients regarding the incidence of each symptom, grade of pyuria, grade of bacteriuria, incidence of Escherichia coli and clinical efficacy. Recurrence was observed in none of 60 premenopausal patients but in four (8.5%) of 47 postmenopausal patients. Ages of the four patients with recurrence ranged from 58 to 75 years, with a mean of 60.5. Mean age of 100 patients without recurrence was 46.9 years, which was significantly lower than that of the recurrence group. Of the three major symptoms of acute cystitis, pain on micturition was most prevalent, occurring in 93.8% of the cases, followed by urinary frequency in 91.9% and a sense of residual urine in 82.4%. The duration of symptoms from onset was within one week in 95.8% and within two weeks in 98.7% of the cases. The incidences of gram-positive and gram-negative bacteria relating to the method of urine collection and bacterial counts are shown in Table 1. When urine specimens were obtained by catheterization, the incidence of gram-positive and gram-negative bacteria was constant, regardless of bacterial counts. However, when urine specimens were obtained by conventional midstream catch, the incidence of gram-negative bacteria was significantly low even in patients with bacteriuria of 104 cfu/ml.
Y. Kawada, M. D., Dept. of Urology, Gifu University School of Medicine, 40 Tsukasa-machi, Gifu-shi 500, Japan.
Infection 20 (1992) Suppl. 3 © MMV Medizin Verlag GmbH MiJnchen, M0nchen 1992
S 143
Y. Kawada: Inclusion Criteria for Acute Cystitis Table 1: Bacterial count related to the method of urine collection.
Catheterized
Midstream
103 104 >-105
2 (18.2) 7 (29.2) 41 (17.8)
8 (72.7) 17 (70.8) 188 (81.7)
1 (9.I) 0 1 (0.4)
11 24 230
103
0 13 (68.4) 18 (24.3)
1 4 (21.1) 51 (68.9)
0 2 (10.5) 5 (6.8)
1 19 74
10 4
>-105 *GPB: Gram-positive bacteria; **GNB: Gram-negative bacteria.
Discussion
The numbers of elderly patients suffering from acute cystitis have increased in recent years. In this study, 44% of the cases were postmenopausal, and recurrence was observed only in postmenopausat patients. Therefore, data on recurrence should be stratified by age or menopause, and care should be taken to exclude patients with underlying urinary disease if the u p p e r age limit is not fixed. According to the Japanese criteria, only patients with pain on micturition are to be included. However, patients with urinary frequency or a sense of residual urine may also be included, because the incidence of these two symptoms was high. A two-week duration of symptoms can be regarded as proof of acute infection. In acutely symptomatic women with uncomplicated infections, an appropriate threshold value for defining "significant bacteriuria" is reported to be 102 or 103 cfu/ml of a recognized uropathogen [3].
S 144
In this study, however, the incidence of gram-negative bacteria, including E. coli, was significantly low even in patients with bacteriuria of 10 4 cfu/ml of urine collected by conventional midstream catch. Therefore, bacteriuria of 10 3 and 104 cfu/ml can be included only when urine is collected by catheterization or a very careful clean-catch method.
References
1. Naber, K. G., Kllmamoto, Y.: Summary of discussion for acute uncomplicated cystitis. In: Ohkoshi, M., Kawada, Y. (eds.): Clinical evaluation of drug efficacy in LrrI. Excerpta Medica, Amsterdam 1990, p. 230. 2. Kawada, Y.: An outline of Japanese criteria for evaluating the clinical efficacy of antimicrobial agents in acute uncomplicated cystitis. In: Ohkoshi, M., Kawada, Y. (eds.): Clinical evaluation of drug efficacyin I.YI'I.Excerpta Medica, Amsterdam 1990, pp. 185-t95. 3. Stamm, W. E., Counts, G. W., Running, K. R., Fihn, S., Tnrek, M., Holmes, K. K.: Diagnosis of coliform infection in acutely dysuric
women. N. Engl. J. Med. 307 (1982) 463-468.
Infection 20 (1992) Suppl. 3 © MMV Medizin Verlag GmbH Miinchen, Miinchen 1992
inclusion Criteria for Acute Uncomplicated Cystitis Patients and Methods Summary: Inclusion criteria for acute uncomplicated cystitis were studied in a total of 307 patients. The data on recurrence should be grouped according to age or menopause, because recurrence was observed only in postmenopausal patients, and the mean age was significantly higher in the recurrence group than in the non-recurrence group. Bacteriuria of 103 and 104 cfu/ml could be included only when urine was collected by catheterization or very careful clean-catch method, because the incidence of uropathogens was significantly low even in patients with bacteriuria of 104 cfu/ml, when urine was collected by conventional midstream catch. Zusammenfassung: Einschluflkriterien far die akute Zystitis. Die Einschlugkriterien fiir die akute unkomplizierte Zystitis wurden bei insgesamt 307 Patientinnen fiberprtift. Die H/iufigkeit rezidivierender Zystitiden sollte nach dem Alter oder dem Zeitpunkt der Menopause eingeteilt werden, da Rezidive nur bei Frauen in der Menopause auftraten und das mittlere Alter in der Gruppe mit Rezidiven hfher als in der Gruppe ohne Rezidive war. Eine Bakteriurie mit einer Keimzahl yon 103/ml und 104/ml sollte nur dann als Einschluf3kriterium gelten, wenn der Urin mittels Einmalkatheterismus oder mittels sorgf/iltiger Mittelstrahltechnik nach vorheriger Reinignng (clean catch) gewonnen wurde. Bei Verwendung der fiblichen Mittelstrahltechnik fanden sich bei diesen Keimzahlen nur bei wenigen Patientinnen uropathogene Erreger, selbst wenn die Keimzahl bei 104/ml lag.
Introduction According to the inclusion criteria for acute uncomplicated cystitis on which an agreement was reached at the First International Symposium on Clinical Evaluation of Drug Efficacy in UTI held in Tokyo in October 1989, only female patients over 16 years of age with pain on micturition, urinary frequency or sense of residual urine, pyuria of at least 10 leucocytes per high power microscopic field (HPF) and bacteriuria of at least 103 colony forming unit (CFU) per ml of urine are to be included in the study for evaluating the clinical efficacy and safety of antimicrobial agents for acute uncomplicated cystitis [1]. The duration of symptoms from onset and upper age limit are not fixed in these criteria. In this paper, the practicability of these criteria was studied.
The study population consisted of a total of 307 female patients
from seven different institutions in Japan who met the above criteria and who were shown to have no underlying urinary tract disease. Patients were treated with either oral sparfloxacin (100 mg once daily) or enoxacin (100 mg t.i.d.) for three or seven days. The background characteristics of all patients were analyzed. Clinical efficacy was evaluated in 202 patients by the criteria proposed by the Japanese UTI Committee as excellent, moderate or poor based on the combination of changes in symptoms, pyuria and bacteriuria [2]. Recurrence was checked in 104 patients seven to ten days after completion of treatment. Patients with pyuria of 10 leucocytes/HPF or more and bacteriuria of 104 cfu/ml or more after completion of treatment were assessed a s "recurrence."
Results The ages of 307 patients ranged from 17 to 78 years with an almost equal distribution between 20 and 60. Consequently, 44.3% of the patients were postmenopausal. Excellent and moderate responses were obtained in 200 (99.0%) of 202 patients. No significant differences were observed between premenopausal and postmenopausal patients regarding the incidence of each symptom, grade of pyuria, grade of bacteriuria, incidence of Escherichia coli and clinical efficacy. Recurrence was observed in none of 60 premenopausal patients but in four (8.5%) of 47 postmenopausal patients. Ages of the four patients with recurrence ranged from 58 to 75 years, with a mean of 60.5. Mean age of 100 patients without recurrence was 46.9 years, which was significantly lower than that of the recurrence group. Of the three major symptoms of acute cystitis, pain on micturition was most prevalent, occurring in 93.8% of the cases, followed by urinary frequency in 91.9% and a sense of residual urine in 82.4%. The duration of symptoms from onset was within one week in 95.8% and within two weeks in 98.7% of the cases. The incidences of gram-positive and gram-negative bacteria relating to the method of urine collection and bacterial counts are shown in Table 1. When urine specimens were obtained by catheterization, the incidence of gram-positive and gram-negative bacteria was constant, regardless of bacterial counts. However, when urine specimens were obtained by conventional midstream catch, the incidence of gram-negative bacteria was significantly low even in patients with bacteriuria of 104 cfu/ml.
Y. Kawada, M. D., Dept. of Urology, Gifu University School of Medicine, 40 Tsukasa-machi, Gifu-shi 500, Japan.
Infection 20 (1992) Suppl. 3 © MMV Medizin Verlag GmbH MiJnchen, M0nchen 1992
S 143
Y. Kawada: Inclusion Criteria for Acute Cystitis Table 1: Bacterial count related to the method of urine collection.
Catheterized
Midstream
103 104 >-105
2 (18.2) 7 (29.2) 41 (17.8)
8 (72.7) 17 (70.8) 188 (81.7)
1 (9.I) 0 1 (0.4)
11 24 230
103
0 13 (68.4) 18 (24.3)
1 4 (21.1) 51 (68.9)
0 2 (10.5) 5 (6.8)
1 19 74
10 4
>-105 *GPB: Gram-positive bacteria; **GNB: Gram-negative bacteria.
Discussion
The numbers of elderly patients suffering from acute cystitis have increased in recent years. In this study, 44% of the cases were postmenopausal, and recurrence was observed only in postmenopausat patients. Therefore, data on recurrence should be stratified by age or menopause, and care should be taken to exclude patients with underlying urinary disease if the u p p e r age limit is not fixed. According to the Japanese criteria, only patients with pain on micturition are to be included. However, patients with urinary frequency or a sense of residual urine may also be included, because the incidence of these two symptoms was high. A two-week duration of symptoms can be regarded as proof of acute infection. In acutely symptomatic women with uncomplicated infections, an appropriate threshold value for defining "significant bacteriuria" is reported to be 102 or 103 cfu/ml of a recognized uropathogen [3].
S 144
In this study, however, the incidence of gram-negative bacteria, including E. coli, was significantly low even in patients with bacteriuria of 10 4 cfu/ml of urine collected by conventional midstream catch. Therefore, bacteriuria of 10 3 and 104 cfu/ml can be included only when urine is collected by catheterization or a very careful clean-catch method.
References
1. Naber, K. G., Kllmamoto, Y.: Summary of discussion for acute uncomplicated cystitis. In: Ohkoshi, M., Kawada, Y. (eds.): Clinical evaluation of drug efficacy in LrrI. Excerpta Medica, Amsterdam 1990, p. 230. 2. Kawada, Y.: An outline of Japanese criteria for evaluating the clinical efficacy of antimicrobial agents in acute uncomplicated cystitis. In: Ohkoshi, M., Kawada, Y. (eds.): Clinical evaluation of drug efficacyin I.YI'I.Excerpta Medica, Amsterdam 1990, pp. 185-t95. 3. Stamm, W. E., Counts, G. W., Running, K. R., Fihn, S., Tnrek, M., Holmes, K. K.: Diagnosis of coliform infection in acutely dysuric
women. N. Engl. J. Med. 307 (1982) 463-468.
Infection 20 (1992) Suppl. 3 © MMV Medizin Verlag GmbH Miinchen, Miinchen 1992
