Single-dose oral ciprofloxacin versus placebo for prophylaxis during transrectal prostate biopsy

Deepak A. Kapoor, Ira W. Klimberg, Gholam H. Malek, John D. Wegenke, Clair E. Cox, Anthony Patterson, Evelyn Graham, Roger M. Echols, Edward Whalen, Steven E. Kowalsky

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Abstract

Objectives. To determine whether antimicrobial prophylaxis could prevent infections after transrectal needle biopsy of the prostate using automated biopsy devices. Methods. We conducted a prospective, randomized, double- blind, multicenter trial in which a total of 537 patients received either oral ciprofloxacin 500 mg or placebo before transrectal needle biopsy of the prostate. Repeated urine cultures and urinalysis were obtained at 2 to 6 days after biopsy and 9 to 15 days after biopsy. The primary determinant of efficacy was bacteriologic response (bacteriuria [more than 104 colony- forming units (CFU)/mL] versus no bacteriuria) at the 9- to 15-day follow-up evaluation. Results. Two hundred twenty-seven (84%) of 269 ciprofloxacin patients and 230 (86%) of 268 placebo patients were valid for efficacy analysis in which a mean of four biopsies was performed. Six ciprofloxacin- treated (3%) and 19 placebo-treated (8%) patients had bacteriuria (more than 104 CFU/mL) after the procedure (P = 0.009). Six ciprofloxacin recipients (3%) and 12 placebo recipients (5%) had clinical signs and symptoms of a urinary tract infection (UTI) (P = 0.15). In addition, no ciprofloxacin- treated patients compared with 4 placebo-treated patients (2%) were admitted to the hospital for febrile UTI after the procedure. Ciprofloxacin reduced the expected net costs of treating infectious complications after biopsy by $23 per patient for an overall annual savings of $68,195 in the five study groups when compared with placebo. Conclusions. Single-dose oral ciprofloxacin reduced bacteriuria after biopsy compared with placebo in patients undergoing transrectal prostatic biopsy and provided an economic advantage. In addition, this study establishes the actual rate of bacteriuria after transrectal needle biopsy of the prostate without antibiotic prophylaxis to be 8% with a clinical rate of UTI of 5% and a hospitalization rate of 2%.

Original languageEnglish (US)
Pages (from-to)552-558
Number of pages7
JournalUrology
Volume52
Issue number4
DOIs
StatePublished - Oct 1 1998

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Ciprofloxacin
Prostate
Bacteriuria
Placebos
Biopsy
Needle Biopsy
Urinary Tract Infections
Stem Cells
Urinalysis
Antibiotic Prophylaxis
Multicenter Studies
Signs and Symptoms
Hospitalization
Fever
Economics
Urine
Costs and Cost Analysis
Equipment and Supplies
Infection

All Science Journal Classification (ASJC) codes

  • Urology

Cite this

Kapoor, D. A., Klimberg, I. W., Malek, G. H., Wegenke, J. D., Cox, C. E., Patterson, A., ... Kowalsky, S. E. (1998). Single-dose oral ciprofloxacin versus placebo for prophylaxis during transrectal prostate biopsy. Urology, 52(4), 552-558. https://doi.org/10.1016/S0090-4295(98)00296-9

Single-dose oral ciprofloxacin versus placebo for prophylaxis during transrectal prostate biopsy. / Kapoor, Deepak A.; Klimberg, Ira W.; Malek, Gholam H.; Wegenke, John D.; Cox, Clair E.; Patterson, Anthony; Graham, Evelyn; Echols, Roger M.; Whalen, Edward; Kowalsky, Steven E.

In: Urology, Vol. 52, No. 4, 01.10.1998, p. 552-558.

Research output: Contribution to journalArticle

Kapoor, DA, Klimberg, IW, Malek, GH, Wegenke, JD, Cox, CE, Patterson, A, Graham, E, Echols, RM, Whalen, E & Kowalsky, SE 1998, 'Single-dose oral ciprofloxacin versus placebo for prophylaxis during transrectal prostate biopsy', Urology, vol. 52, no. 4, pp. 552-558. https://doi.org/10.1016/S0090-4295(98)00296-9
Kapoor, Deepak A. ; Klimberg, Ira W. ; Malek, Gholam H. ; Wegenke, John D. ; Cox, Clair E. ; Patterson, Anthony ; Graham, Evelyn ; Echols, Roger M. ; Whalen, Edward ; Kowalsky, Steven E. / Single-dose oral ciprofloxacin versus placebo for prophylaxis during transrectal prostate biopsy. In: Urology. 1998 ; Vol. 52, No. 4. pp. 552-558.
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abstract = "Objectives. To determine whether antimicrobial prophylaxis could prevent infections after transrectal needle biopsy of the prostate using automated biopsy devices. Methods. We conducted a prospective, randomized, double- blind, multicenter trial in which a total of 537 patients received either oral ciprofloxacin 500 mg or placebo before transrectal needle biopsy of the prostate. Repeated urine cultures and urinalysis were obtained at 2 to 6 days after biopsy and 9 to 15 days after biopsy. The primary determinant of efficacy was bacteriologic response (bacteriuria [more than 104 colony- forming units (CFU)/mL] versus no bacteriuria) at the 9- to 15-day follow-up evaluation. Results. Two hundred twenty-seven (84{\%}) of 269 ciprofloxacin patients and 230 (86{\%}) of 268 placebo patients were valid for efficacy analysis in which a mean of four biopsies was performed. Six ciprofloxacin- treated (3{\%}) and 19 placebo-treated (8{\%}) patients had bacteriuria (more than 104 CFU/mL) after the procedure (P = 0.009). Six ciprofloxacin recipients (3{\%}) and 12 placebo recipients (5{\%}) had clinical signs and symptoms of a urinary tract infection (UTI) (P = 0.15). In addition, no ciprofloxacin- treated patients compared with 4 placebo-treated patients (2{\%}) were admitted to the hospital for febrile UTI after the procedure. Ciprofloxacin reduced the expected net costs of treating infectious complications after biopsy by $23 per patient for an overall annual savings of $68,195 in the five study groups when compared with placebo. Conclusions. Single-dose oral ciprofloxacin reduced bacteriuria after biopsy compared with placebo in patients undergoing transrectal prostatic biopsy and provided an economic advantage. In addition, this study establishes the actual rate of bacteriuria after transrectal needle biopsy of the prostate without antibiotic prophylaxis to be 8{\%} with a clinical rate of UTI of 5{\%} and a hospitalization rate of 2{\%}.",
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AU - Kapoor, Deepak A.

AU - Klimberg, Ira W.

AU - Malek, Gholam H.

AU - Wegenke, John D.

AU - Cox, Clair E.

AU - Patterson, Anthony

AU - Graham, Evelyn

AU - Echols, Roger M.

AU - Whalen, Edward

AU - Kowalsky, Steven E.

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N2 - Objectives. To determine whether antimicrobial prophylaxis could prevent infections after transrectal needle biopsy of the prostate using automated biopsy devices. Methods. We conducted a prospective, randomized, double- blind, multicenter trial in which a total of 537 patients received either oral ciprofloxacin 500 mg or placebo before transrectal needle biopsy of the prostate. Repeated urine cultures and urinalysis were obtained at 2 to 6 days after biopsy and 9 to 15 days after biopsy. The primary determinant of efficacy was bacteriologic response (bacteriuria [more than 104 colony- forming units (CFU)/mL] versus no bacteriuria) at the 9- to 15-day follow-up evaluation. Results. Two hundred twenty-seven (84%) of 269 ciprofloxacin patients and 230 (86%) of 268 placebo patients were valid for efficacy analysis in which a mean of four biopsies was performed. Six ciprofloxacin- treated (3%) and 19 placebo-treated (8%) patients had bacteriuria (more than 104 CFU/mL) after the procedure (P = 0.009). Six ciprofloxacin recipients (3%) and 12 placebo recipients (5%) had clinical signs and symptoms of a urinary tract infection (UTI) (P = 0.15). In addition, no ciprofloxacin- treated patients compared with 4 placebo-treated patients (2%) were admitted to the hospital for febrile UTI after the procedure. Ciprofloxacin reduced the expected net costs of treating infectious complications after biopsy by $23 per patient for an overall annual savings of $68,195 in the five study groups when compared with placebo. Conclusions. Single-dose oral ciprofloxacin reduced bacteriuria after biopsy compared with placebo in patients undergoing transrectal prostatic biopsy and provided an economic advantage. In addition, this study establishes the actual rate of bacteriuria after transrectal needle biopsy of the prostate without antibiotic prophylaxis to be 8% with a clinical rate of UTI of 5% and a hospitalization rate of 2%.

AB - Objectives. To determine whether antimicrobial prophylaxis could prevent infections after transrectal needle biopsy of the prostate using automated biopsy devices. Methods. We conducted a prospective, randomized, double- blind, multicenter trial in which a total of 537 patients received either oral ciprofloxacin 500 mg or placebo before transrectal needle biopsy of the prostate. Repeated urine cultures and urinalysis were obtained at 2 to 6 days after biopsy and 9 to 15 days after biopsy. The primary determinant of efficacy was bacteriologic response (bacteriuria [more than 104 colony- forming units (CFU)/mL] versus no bacteriuria) at the 9- to 15-day follow-up evaluation. Results. Two hundred twenty-seven (84%) of 269 ciprofloxacin patients and 230 (86%) of 268 placebo patients were valid for efficacy analysis in which a mean of four biopsies was performed. Six ciprofloxacin- treated (3%) and 19 placebo-treated (8%) patients had bacteriuria (more than 104 CFU/mL) after the procedure (P = 0.009). Six ciprofloxacin recipients (3%) and 12 placebo recipients (5%) had clinical signs and symptoms of a urinary tract infection (UTI) (P = 0.15). In addition, no ciprofloxacin- treated patients compared with 4 placebo-treated patients (2%) were admitted to the hospital for febrile UTI after the procedure. Ciprofloxacin reduced the expected net costs of treating infectious complications after biopsy by $23 per patient for an overall annual savings of $68,195 in the five study groups when compared with placebo. Conclusions. Single-dose oral ciprofloxacin reduced bacteriuria after biopsy compared with placebo in patients undergoing transrectal prostatic biopsy and provided an economic advantage. In addition, this study establishes the actual rate of bacteriuria after transrectal needle biopsy of the prostate without antibiotic prophylaxis to be 8% with a clinical rate of UTI of 5% and a hospitalization rate of 2%.

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