A double-blind comparative trial of short-term orally administered enoxacin in the prevention of urinary infection after elective transurethral prostatectomy: a clinical and pharmacokinetic study.
A double-blind randomized comparative study was done to investigate the efficacy of enoxacin in the prevention of urinary infection after elective transurethral prostatectomy, as well as its ability to penetrate the prostate. A total of 40 patients received 200 mg. enoxacin and 40 received a placebo, given orally the night before the operation, 2 to 4 hours preoperatively and every 12 hours postoperatively for 36 hours. Urine samples for bacterial culture were obtained within 1 week preoperatively, at operation and at 48 hours, 5 days, and 2 and 6 weeks postoperatively. Samples of the serum and prostate were taken at operation and assayed for enoxacin levels. Of the placebo patients 15 had a urinary infection postoperatively (38 per cent) compared to 3 enoxacin patients (8 per cent) (p less than 0.01). Enoxacin penetrated well into prostatic tissue; the mean levels in tissue and serum were 3.1 +/- 1.8 mg. per kg. (standard deviation) and 1.26 +/- 0.48 mg. per l., respectively, with a mean tissue-to-serum ratio of 2.53 +/- 1.8.
D000328:Adult; D000368:Aged; D000892:Anti-Infective Agents, Urinary / Q000493:pharmacokinetics / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D015365:Enoxacin; D006801:Humans; D008297:Male; D008875:Middle Aged; D009287:Naphthyridines / Q000493:pharmacokinetics / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000517:prevention & control*; D011467:Prostate / Q000378:metabolism; D011468:Prostatectomy; D011470:Prostatic Hyperplasia / Q000601:surgery; D011897:Random Allocation; D013997:Time Factors; D014552:Urinary Tract Infections / Q000517:prevention & control*
D000892:Anti-Infective Agents, Urinary; D009287:Naphthyridines; D015365:Enoxacin