[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.

[Sexual dysfunction in Russia: risk factors for women].

The aim of the study was to identify the most important risk factors in genesis of female sexual dysfunction (FSD) using a Russian modification of the female sexual function index (FSFI) questionnaires and original questionnaires for Russian women. A total of 540 women aged 18-75 years living in the South of Russia entered the trial. They were divided into 4 groups: group 1--18-30 year old women (n = 250), group 2--premenopausal women (n = 213), group 3--women with 5 year and less menopause (n = 39), group 4--women with 5 year and longer menopause. Age, stress and menopause were identified to be significant risk factors of FSD. The other factors were not significant. A mathematical model was designed and the coefficient of each risk factor was estimated for determination of individual probability to develop FSD in Russian women.

[Prevalence of female sexual dysfunction in Rostov on Don].

We assessed the prevalence of sexual dysfunction in the women living in the South of Russia. The study included 540 women aged between 18-75 years (mean age 35.3 +/- 0.505 years) who filled in an original 14-point questionnaire and modified for Russia the female sexual function index (FSFI) questionnaire. The women were divided into four age groups: group 1 (n = 253)--18-30 years; group 2 (n = 175)--31-45 years; group 3 (n = 76)--46-55 years; group 4 (n = 40)--over 55 years. For 540 women the mean total point was 24.75. FSFI under 24.75 was found in 247 (45.5%) women. The mean total point was 23.43 +/- 0.366 for group 1, 22.15 +/- 0.504 for group 2, 16.71 +/- 0.504 for group 3, 16.71 +/- 1.05 for group 4. Mean points by desire were 4.43 +/- 0.071, 3.75 +/- 0.094, 2.93 +/- 0.14, 2.35 +/- 0.23, respectively. By arousal, 4.33 +/- 0.077, 3.87 +/- 0.105, 2.73 +/- 0.18 and 2.04 +/- 0.28, respectively. By lubrication, 4.66 +/- 0.097, 4.44 +/- 0.125, 3.13 +/- 0.25, 1.86 +/- 0.32, respectively. By orgasm, 3.48 +/- 0.069, 3.43 +/- 0.08, 2.57 +/- 0.18, 1.7 +/- 0.27, respectively. By satisfaction, 4.53 +/- 0.101, 4.33 +/- 0.13, 3.26 +/- 0.25, 1.97 +/- 0.39, respectively. By pain, 2.33 +/- 0.085, 2.31 +/- 0.099, 2.07 +/- 0.17, 1.02 +/- 0.2, respectively. Thus, 45.5% women in the south of Russia have sexual dysfunction. Desire, arousal, lubrication and orgasm disorders are more pronounced.