Introduction. Currently, there is a renaissance of phenazopyridine in world urology. The aim of this work was to study the analgesic and antidysuric effects of phenazopyridine, as well as to evaluate the efficacy and tolerability of phenazopyridine in combination with fosfomycin for the treatment of acute uncomplicated cystitis in women of working age.
Materials and methods. In 2020–2022 a multicenter randomized open study was conducted. This study involved 224 women aged 18 to 60 years with acute uncomplicated cystitis. They were randomized into two groups of 112 people each. In the first group, patients received oral phenazopyridine (Urinalgin F, earlier Fenazalgin) 200 mg 3 times a day for 2 days (total dose 1200 mg) and fosfomycin trometamol (Monural) at a dose of 3 g once. In the 2nd group, women received orally once 3 g of fosfomycin trometamol and drotaverine hydrochloride (No-spa) 80 mg 3 times a day for 2 days. The visual analogue scale (VAS) of pain, the assessment of symptoms of cystitis according to the ACSS scale, urinalysis by microscopy, and bacteriological examination of urine were used. The results were evaluated after 6, 12, 24 and 48 hours, 3 and 6 days.
Results. In the 1st group, a strong uroanalgesic and antidysuric effect of phenazopyridine was revealed. According to VAS, the severity of pain decreased from the initial 7.3±0.5 points after 6 hours to 3.7±0.4 points, after 12 hours to 1.6 points, after 24 hours to 0.4 points, and after 48 hours the pain disappeared in all 112 patients. The sum of the characteristic symptoms of cystitis on the ACSS scale from the initial 12.2±0.5 points decreased to 2.1±0.2 points after 3 days, and to 0.27±0.04 points after 6 days. In patients of the 2nd group, for all indicators, a less pronounced symptomatic effect was obtained with relief of pain and dysuria. The combined treatment of cystitis with fosfomycin and phenazopyridine turned out to be more effective than the combination of fosfomycin and drotaverine hydrochloride: in the 1st group, 97.3% of patients recovered, bacteriological efficiency was 96.8%, leukocyturia disappeared at an earlier date, by 30% reduced treatment time. An undesirable effect of phenazopyridine (nausea) was detected in 1 (0.9%) patient.
Сonclusion. Phenazopyridine has a pronounced uroanalgesic and antidysuric effect and is an effective and safe agent for the symptomatic treatment of patients with acute uncomplicated cystitis. The combination of the antibiotic fosfomycin and the uroanalgesic phenazopyridine improves the results of the treatment of acute uncomplicated cystitis, has a clinical efficacy of 97.3% and a bacteriological efficacy of 96.8%.