[Phenazopyridine and fosfomycin for the acute cystitis treatment: results of multicenter randomized study].

AIM: To evaluate the analgesic effect, efficacy and tolerability of phenazopyridine in combination with fosfomycin for the treatment of acute uncomplicated cystitis in working-age female. MATERIAL AND METHODS: A total of 152 women with acute uncomplicated cystitis were included in multicenter, randomized, open-label study which were carried out in 5 polyclinics of the Perm Territory. All the patients were divided into 2 groups of 76 people each, depending on the treatment. In the main group, women received oral phenazopyridine 200 mg 3 times a day for 2 days (a total dose 1200 mg) and fosfomycin trometamol in a dose of 3 g once. In the control group, patients received a single dose of fosfomycin trometamol (3 g) and drotaverin 80 mg 3 times a day for 2 days. A visual analogue scale (VAS) was used for evaluation of pain intensity. The symptoms of cystitis were assessed using the ACSS scale. In addition, urinalysis, urine culture and other methods were done. The results were evaluated after 6, 12, 24, 48 hours, 3 and 6 days. RESULTS: In the main group, the severity of pain according to the VAS decreased from the initial 7.2+/-0.5 points to 1.6+/-0.2 points after 12 hours, to 0.4 +/- 0.05 points after 24 hours. Pain syndrome completely disappeared in all patients after 48 hours. In the control group, at all time points, a significant less pronounced analgesic effect was seen (p<0.001). The overall ACSS score in the main group decreased from the 12.0+/-0.5 points to 2.1+/-0.3 after 3 days and to 0.28+/-0.04 points after 6 days (p<0.001), which indicated a more rapid resolution of symptoms compared to the control group. The symptomatic effect of phenazopyridine (relief of pain, dysuria and discomfort) provided a more pronounced improvement in the well-being in the main group in comparison to the control group, which was confirmed by Dynamics domain of the ACSS scale (p<0.001). The combination of fosfomycin and phenazopyridine was more effective than the combination of fosfomycin and drotaverine. The clinical and microbiological cure rate in the main group was 97.4% and 96.9%, respectively. Leukocyturia was resolved earlier, and the duration of treatment decreased by 30.1%. An undesirable effect of phenazopyridine (nausea) was detected only in 1 (1.3%) patient. CONCLUSION: Phenazopyridine has a pronounced analgesic effect and is proved to be an effective and safe drug in patients with acute uncomplicated cystitis.

[Treatment of acute uncomplicated cystitis in women with antibiotic allergy or intolerance].

AIM: A comparative evaluation of the efficacy and safety of Canephron N and Cystone as monotherapy in women with acute uncomplicated cystitis and antibiotic allergy or intolerance was performed. MATERIALS AND METHODS: A prospective, randomized, controlled study of drug Canephron N as monotherapy for acute uncomplicated cystitis in 51 women with a history of antibiotic allergy or intolerance was carried out in 3 urological centers in Perm from 2016 to 2019. In the main group, patients received Canephron N for 30 days, while in comparison group, Cystone was prescribed. The Acute Cystitis Symptom Score (ACSS), microscopic study of urine sediment, urine culture and other methods were used. Results were evaluated 3, 6, 30 days and 1 year after the start of treatment. RESULTS: In the main group, monotherapy with Canephron N for 30 days resulted in a decrease in the total ACSS score from the baseline 12.9 to 0.3 points, while in Cyston group, changes of ACSS score were less pronounced, from baseline 12.8 to 1.4 points (p<0.01). Clinical cure rate in the main and comparison group was 88.5% and 68%, respectively. In another 3.8% and 1% of patients in the main and comparison group, an improvement was seen. The number of patients with leukocyturia in the Canephron N group decreased to 11.5% compared to 28% in Cyston group (p>0.05). Bacteriuria rate in the main group was 7.7%, which was less than in the comparison group (20%, p>0.05). Number of sick days in the main group was 4.9+/-0.4, compared to 7.4+/-0.6 days in Cyston group. In the Canephron N group, 1-year recurrence rate was only 7.7%, while in the Cyston group the recurrence was seen in 16% of patients. CONCLUSION: According to the results, Canephron N is an effective and safe drug as monotherapy for acute uncomplicated cystitis, and can be considered as drug of choice for the treatment of women with antibiotic allergy or intolerance.

[Comparative assessment of Canephron N and ciprofloxacin as monotherapy of acute uncomplicated cystitis in women].

The study aimed to compare the efficacy and safety of Canephron N and ciprofloxacin as monotherapy in the management of mild forms of acute uncomplicated cystitis in women of working age. MATERIALS AND METHODS: A prospective, randomized study of Canephron N and ciprofloxacin for treating mild forms of acute uncomplicated cystitis (ACSS score less or equal 10) comprising 160 women aged 18-55 years was conducted from 2015 to 2017. Group I consisted of 80 women, who received oral Canephron N 2 tablets 3 times daily for 30 days. Group II included 80 women who took oral ciprofloxacin 0.5 g twice daily for 3 days. The results were assessed using the ACSS scale, urinalysis by microscopy, bacteriological examination of urine, etc. The outcomes were evaluated at 3, 6 and 30 days, and one year after the treatment initiation. RESULTS: In group I, monotherapy with Canephron NH resulted in a marked improvement in symptoms, a decrease in the ACSS scores from 7.9 at baseline to 0.1 at day 30. The indicator of clinical efficacy (recovery) was 93.75%, bacteriological efficiency was 91.3%, relapse of cystitis within one year was observed in 5% of patients; no side effects were registered. In group II, the symptoms and bacteriuria decreased more rapidly in the early periods, but after 30 days the results of clinical and bacteriological efficacy did not differ from the group I (93.75 and 91.3%, respectively). Side effects and cystitis relapses were noted in 18.8% and 12.5% of patients, respectively. CONCLUSION: The findings of the study show that Canephron N is an effective and safe alternative to treating mild forms (ACSS score less or equal 10) of acute uncomplicated cystitis in women, allowing the use of antibiotics to be reduced. In our opinion, patients with more severe forms of acute uncomplicated cystitis should be treated with traditional antibiotic therapy.

[Treatment of chronic cystitis in postmenopausal women].

A randomized double blind controlled trial of intravaginal cream ovestin (estriol) was conducted in 102 postmenopausal females with chronic cystitis. The patients were divided into two groups. Group 1 (n = 52) received standard therapy, group 2 (n = 50) received standard therapy plus ovestin (daily intravaginal administration for 2 weeks, then twice a week). Final results were evaluated 1 year after therapy. Before the treatment 94% patients had subnormal levels of blood estradiol. One year after the treatment positive results were achieved in 91.3% patients of group 2 and 65.8% of group 1 (p < 0.001). In group 2 patients ovestin significantly reduced pollakiuria, nocturia, episodes of urgent urinary incontinence, painful voiding. Percentage of patients with leukocyturia diminished from 100 to 8%, bacteriuria--from 74 to 4%, with vaginal lactobacilli increased from 0 to 56%, enterobacterial contamination of the vagina fell from 66 to 12%. Vaginal pH decreased from 6.0 to 3.6. Addition of ovestin to standard therapy reduced the number of cystitis recurrences 11-fold, days of antibacterial therapy--12.4-fold. Side effects of ovestin (vaginal pruritus) were seen in 4% patients.