Surgical treatment of urethral stricture disease - the earlier, the better.

INTRODUCTION: Surgical treatment of urethral strictures is a constantly evolving process. There are various treatment options like internal urethrotomy (IUT) and open surgery. A variety of techniques for urethral reconstruction are available (grafts, flaps, and excision-reanastomosis). Functional results of urethral reconstructive surgery are very satisfying and with low rate of complications. AIM: We assessed the early open surgical reconstruction in comparison with the continuation with the endourological treatment - IUTs. MATERIALS AND METHODS: The study included 129 patients with urethral strictures referred to our center. At that time point, they had received two unsuccessful IUTs and were divided into two groups - consecutive IUT and surgical repair, which included excision and reanastomosis or augmented urethroplasty. These patients were evaluated at 12 months using urethrography and uroflowmetry. Sexual function was evaluated using the international index of erectile function questionnaire 5-IIEF. Chi-squared test for statistical analysis was used. RESULTS: Successful outcomes (urethrography presented equal caliber and Qmax was >15 ml/sec 12 months after the procedure) were achieved in 59 (88%) of the patients using reconstructive surgery versus 26 (41.9%) of the patients with consecutive IUT (p<0.001). Mild sexual dysfunction was reported by 12 (17.9%) patients from the group with open surgery and 7 (11.3%) from the group with continuous IUT (p=0.289). CONCLUSIONS: Early open surgery seems a reasonable solution to the problem of urethral strictures as there are only a few complications from this surgery and the functional results are satisfactory. The success rate using open surgery was found to be significantly greater than that in the consecutive IUT group, whereas no differences in the complication rates regarding sexual function were observed.

Prospective, randomized, double-blind, Phase 2 dose-ranging study comparing efficacy and safety of imipenem/cilastatin plus relebactam with imipenem/cilastatin alone in patients with complicated urinary tract infections.

Objectives: The ß-lactamase inhibitor relebactam can restore imipenem activity against imipenem non-susceptible pathogens. Methods: To explore relebactam's safety, tolerability and efficacy, we conducted a randomized (1:1:1), controlled, Phase 2 trial comparing imipenem/cilastatin+relebactam 250 mg, imipenem/cilastatin+relebactam 125 mg and imipenem/cilastatin alone in adults with complicated urinary tract infections (cUTI) or acute pyelonephritis, regardless of baseline pathogen susceptibility. Treatment was administered intravenously every 6 h for 4-14 days, with optional step-down to oral ciprofloxacin. The primary endpoint was favourable microbiological response rate (pathogen eradication) at discontinuation of intravenous therapy (DCIV) in the microbiologically evaluable (ME) population. Non-inferiority of imipenem/cilastatin+relebactam over imipenem/cilastatin alone was defined as lower bounds of the 95% CI for treatment differences being above -15%. Results: At DCIV, 71 patients in the imipenem/cilastatin + 250 mg relebactam, 79 in the imipenem/cilastatin + 125 mg relebactam and 80 in the imipenem/cilastatin-only group were ME; 51.7% had cUTI and 48.3% acute pyelonephritis. Microbiological response rates were 95.5%, 98.6% and 98.7%, respectively, confirming non-inferiority of both imipenem/cilastatin + relebactam doses to imipenem/cilastatin alone. Clinical response rates were 97.1%, 98.7% and 98.8%, respectively. All 23 ME patients with imipenem non-susceptible pathogens had favourable DCIV microbiological responses (100% in each group). Among all 298 patients treated, 28.3%, 29.3% and 30.0% of patients, respectively, had treatment-emergent adverse events. The most common treatment-related adverse events across groups (1.0%-4.0%) were diarrhoea, nausea and headache. Conclusions: Imipenem/cilastatin + relebactam (250 or 125 mg) was as effective as imipenem/cilastatin alone for treatment of cUTI. Both relebactam-containing regimens were well tolerated. (NCT01505634).

Macroscopic hematuria in patients on anticoagulation therapy.

INTRODUCTION: Visible hematuria is not rare in patients on anticoagulant therapy. There is no consensus regarding the diagnostic approach for them; some authors suggest restricted volume of diagnostic procedures because of the low number of urological etiology found. Some antibiotics have been reported to potentiate the effect of oral anticoagulants. MATERIAL AND METHODS: The study addresses the need for urological assessment of patients on anticoagulation therapy and the possible role of some drugs administrated simultaneously with an oral anticoagulant, for the onset of macroscopic hematuria. Patients hospitalized with hematuria, both with or without anticoagulation therapy, were investigated and followed up. RESULTS: The onset of hematuria depends on the monitoring of oral anticoagulation. INR (International Normalized Ratio) value corresponds with the probability of non-urological etiology, where INR>4 carries relatively low risk for urological and malignant etiology. Some antibiotics may influence the anticoagulation effect, so INR value may be elevated and hematuria may occur. CONCLUSIONS: Anticoagulation therapy should be administrated carefully and individually. The risk of urological etiology of hematuria is lower in patients on oral anticoagulants (especially when INR >4), however, it is not zero.