PURPOSE: We conducted a prospective single-center study to evaluate the possibility of discontinuation of dutasteride after combination therapy with an alpha blocker for benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: We prospectively treated BPH patients with an alpha blocker and dutasteride (0.5 mg/d). Patients who had been treated with alpha blockers against BPH for more than 2 months were eligible, and 20 patients were included in the study. After 6 months of combination therapy, dutasteride was discontinued. Patients were followed for 12 months after cessation. Prostate volume, intraprostatic architecture determined by transrectal ultrasound, peak urinary flow rate, postvoid residual urine volume, and the serum prostate-specific antigen level were evaluated every 6 months, and the International Prostate Symptom Score and overactive bladder symptom score (OABSS) every 3 months. Patients were allowed to restart dutasteride during the follow-up period according to their desire. RESULTS: Twelve patients (12/20, 60%) restarted the combination therapy from 6 to 12 months into the follow-up period. For patients who restarted dutasteride, the prostate volume and OABSS had increased and worsened after discontinuation, respectively. A visible transition zone with a clear border on transrectal ultrasound at baseline and regrowth of the prostate after discontinuation of dutasteride were risk factors for restarting the therapy (Mann-Whitney U test: p=0.008, p=0.017). CONCLUSIONS: Prostatic enlargement after discontinuation of dutasteride differs among patients. Rapid regrowth of the prostate leads to deterioration of storage symptoms and a tendency to restart dutasteride. Baseline intraprostatic architecture may be a predictive factor for whether the patient is a good candidate for discontinuation.
5-alpha Reductase Inhibitors/administration & dosage/adverse effects ; *Adrenergic alpha-Antagonists/administration & dosage/adverse effects ; Aged ; Drug Monitoring ; Drug Therapy, Combination/methods ; *Dutasteride/administration & dosage/adverse effects ; Follow-Up Studies ; Humans ; Japan ; Male ; Middle Aged ; Organ Size ; Prospective Studies ; *Prostate/drug effects/pathology/ultrasonography ; Prostate-Specific Antigen/analysis ; *Prostatic Hyperplasia/drug therapy/pathology ; Secondary Prevention/methods/statistics & numerical data ; Treatment Outcome ; Withholding Treatment

INTRODUCTIONInfection-related complications after transrectal ultrasound guided prostatic biopsy (TRPB) could be life threatening. Our centre observed sepsis after TRPB despite prophylactic oral ciprofloxacin. We reviewed all cases of post-TRPB sepsis with their bacteriology and evaluated if the addition of intramuscular (I/M) gentamicin to standard prophylaxis before TRPB could reduce its incidence.

MATERIALS AND METHODSIn a single urological centre, we performed an interventional study that compared a prospective group with retrospective control. The latter is known as the "cipro-only" group included consecutive patients who underwent TRPB between 1 September 2003 and 31 August 2004. The addition of I/M gentamicin 80 mg half an hour before TRPB started on 1 September 2004. All subsequent patients who underwent TRPB until 31 August 2005 were included in the "cipro+genta" group. Patients who did not receive the studied antibiotics were excluded.

RESULTSThere were 374 patients in the "cipro+genta" group and 367 patients in the "cipro-only" group with comparable profiles. There were 12 cases of post-TRPB sepsis in the "cipro-only" group and 5 cases in the "cipro+genta" group. Ciprofloxacin-resistant Escherichia coli (E. coli) was the only pathogen isolated in both groups. In the "cipro-only" group, 9 patients had positive blood cultures and 8 were sensitive to gentamicin. In the "cipro+genta" group, the only positive E. coli was gentamicin-resistant. One patient in the "cipro+genta" group was admitted to the intensive care unit with septicaemia.

CONCLUSIONThe addition of I/M gentamicin to oral ciprofloxacin is a safe and effective prophylactic antibiotic regime in reducing the incidence of post-TRPB sepsis.

Administration, Oral ; Adult ; Aged ; Antibiotic Prophylaxis ; methods ; Biopsy ; Ciprofloxacin ; administration & dosage ; therapeutic use ; Drug Resistance, Bacterial ; Escherichia coli ; drug effects ; isolation & purification ; Gentamicins ; administration & dosage ; Humans ; Injections, Intramuscular ; Male ; Middle Aged ; Prospective Studies ; Prostate ; diagnostic imaging ; pathology ; Rectum ; Ultrasonography