[The results of the multicenter prospective comparative study of Androgel in men with endogenous testosterone deficiency and lower urinary tract symptoms, associated with benign prostate hyperplasia (POTOK)].

AIM: To evaluate the efficacy and safety of using Androgel in men with endogenous testosterone deficiency and lower urinary tract symptoms (LUTS), associated with benign prostatic hyperplasia (BPH) in routine clinical practice. MATERIALS AND METHODS: The multicenter, prospective, comparative study "POTOK" included 500 patients aged over 50 years with biochemical signs of testosterone deficiency (morning total testosterone concentration <12.1 nmol/l) and LUTS/BPH (International Prostatic Symptoms Score [IPSS] score of 8-19). The recruitment and monitoring of patients was carried out in 2022 in 40 clinics in Russia. Depending on the therapy, all patients were divided into two groups. The physician's decision to prescribe a specific drug (according to the approved patient information leaflet), as well as the subsequent follow-up scheme and therapy, was made a priori and independently of patient. In the first group (n=250) alpha-blockers and Androgel were prescribed, while in the second group (n=250) patients received monotherapy with alpha-blockers. The follow-up duration was 6 months. The efficiency of the therapy was evaluated after 3 and 6 months according to IPSS, symptoms of androgen deficiency (AMS and IIEF scores), uroflowmetry (peak flow rate, total urination volume), ultrasound study (postvoid residual and prostate volume). Safety was assessed by the total number of adverse events, stratified by severity and frequency. Statistical analysis was carried out using IBM SPSS 26.0. RESULTS: According to the primary end-point (IPSS score), there were significant differences between groups 1 and 2 after 3 months (11 vs. 12 points, p=0.009) and 6 months of therapy (9 vs. 11 points, p<0.001). There were also significant differences in the severity of symptoms of androgen deficiency after 3 and 6 months of therapy according to AMS score of 35 vs. 38 points (p<0.001) and 28 vs. 36 points (p<0.001), respectively. According to IIEF, all domains (erectile and orgasmic functions, libido, sexual satisfaction with and general satisfaction) were better in group 1 (p<0.001). After 6 months, uroflowmetry values also differed. In group 1 Qmax was 16 ml/s compared to 15.2 ml/s in group 2 (p=0.004); postvoid residual was 10 ml vs. 15.5 ml, respectively (p=0.001). The prostate volume in group 1 after 6 months of treatment was significantly lower (39.5 cc) compared with group 2 (43.3 cc; p=0.002). During the study, 18 mild AEs, 2 moderate AEs, and 1 severe AE were identified without significant differences between the groups (p>0.05). CONCLUSION: The results of study "POTOK" showed greater efficacy and comparable safety of alpha-blockers in combination with Androgel compared with monotherapy with alpha-blockers in men with LUTS/BPH and endogenous testosterone deficiency in routine clinical practice. The increase in serum testosterone concentrations to normal values in patients with age-related hypogonadism favorably influence on the severity of LUTS and the potentiate the effect of the standard monotherapy with alpha-blockers.

[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.