[Results of three-year clinical study of prostamol uno efficacy and safety in patients with initial symptoms of prostatic adenoma and risk of its progression].

Prostamol Uno (PU) efficacy and safety were studied in a multicenter, open-population, randomized and comparative trial. PU was given in a single daily dose 320 mg for 36 months to 50 patients with initial symptoms of prostatic adenoma (PA) in comparison with 50 matched controls. The trial evaluated PU action on the symptoms progression and quality of life with application of questionnaires IPSS and QoL (BS). It was found that PU treatment relieved PA symptoms by IPSS, while these symptoms progressed in the controls. QoL improved in the study group and deteriorated in the control one. Administration of PU significantly increased urinary flow rate though in the controls urinary flow rate decreased, size of the prostate diminished and increased, respectively. Changes in the PSA were not seen and were insignificant, respectively. The results of the study say that prostamol Uno in a dose 320 mg/day can prevent PA progression without side effects.

Prophylactics of erectile dysfunction in patients with metabolic syndrome.

For prophylactics of erectile dysfunction in patients with metabolic syndrome, all unfavorable life-style factors should be excluded and all metabolic disturbances should be corrected. This will reduce the severity and stabilize the course of metabolic syndrome. Administration of special drugs is required for prevention of erection disturbances.

[Efficacy and safety of prostamol-UNO in the treatment of patients with initial symptoms of prostatic adenoma and risk of progression: 2 years of investigations].

The article presents 2-year pilot results of a multicenter, randomized, controlled trial of prostamol-UNO effects on symptoms progression, quality of life, tolerance and safety in patients with early prostatic adenoma. The drug was used in a single dose 320 mg/day for 36 months. Prostamol-UNO efficacy in arrest of the symptoms progression and quality of life was assessed with the use of IPSS and QoL (BS) questionnaires. Measurements were also made of changes in Qmax, urine volume, residual urine, size of the prostate.

[Vitaprost plus in the treatment of chronic bacterial prostatitis].

Our study has demonstrated that compound medicine vitaprost plus in therapy of chronic bacterial prostatitis (CBP) reduces intensity of prostatic inflammation, significantly relieves symptoms of chronic prostatitis and pain syndrome. The absence of unwanted side effects, significant changes in clinical and biochemical blood and urine parameters evidences for good tolerance and safety of the drug. Thus, rectal suppositories vitaprost plus can be recommended for treatment of chronic bacterial prostatitis caused by both gram-positive and gram-negative bacteria in patients of different age and clinical symptoms.

[Temporary stent--CoreFlow Soft Stent--for diagnosis of the causes of incomplete bladder emptying in men with neurological diseases].

The new device--CoreFlow Soft Stent--was used for diagnosis of causes of incomplete bladder emptying (IBE) in 19 men with neurogenic diseases. Group 1 consisted of 8 men with IBE and prostatic adenoma. Group 2 consisted of 11 men with IBE but no prostatic adenoma. The CoreFlow Soft Stent comprises an introducer and a stent. Different active lengths of the stent are available to match it to the length of the prostatic urethra. The stent has an anchoring balloon situated in the bladder and a second anchor located distally to the external sphincter. CoreFlow was introduced in a similar way as an ordinary Foley catheter. The bladder was filled with 200 ml of saline solution through the introducer and the stent. The introducer part was then separated from the stent part positioned in the prostatic urethra. The stent part is connected to the integral "pull-thread" device which runs through the urethra ending outside the meatus. Reposition of the stent using the special thread opens the striated urethral sphincter. Out of 8 patients with prostatic adenoma and neurogenic diseases 4 could urinate with the stent part positioned in the prostatic urethra indicating that prostatic adenoma was the cause for IBE. These patients have undergone TUR. The other 4 patients of group 1 and 11 patients of group 2 could urinate only using Valsalva manoeuvre and after reposition of the stent for opening the striated urethral sphincter. This allowed us to conclude that these 15 patients suffered from detrusor underactivity. Our experience indicates that CoreFlow Soft Stent is a simple device for diagnosis of the causes of IBE in men with neurogenic diseases.

[Administration of oral vitaprost for prevention of exacerbations of chronic abacterial prostatitis].

Active substance of vitaprost is a complex of water-soluble biologically active peptides isolated from bovine prostate. The prostatic extract has an organotropic action in relation to the prostate. As all peptide bioregulators, prostatic extract has antiaggregant and anticoagulant properties, enhances synthesis of antihistamine and antiserotonine antibodies, improves microcirculation in the prostatic gland. This accounts for its ability to reduce edema in prostatic inflammation. This clinical trial demonstrated that vitaprost tablets decreases twice probability of chronic prostatitis exacerbation, of development of secondary exacerbations. A prophylactic intake of vitaprost relieves symptoms of chronic prostatitis, first of all pain (discomfort), improvement of quality of life by NIH-CPSI, including exacerbation and significantly reduces size of the prostate. Vitaprost tablets can be effectively used prophylactively in chronic prostatitis for reducing probability of the disease exacerbations and their severity.

[Efficacy of phosphodiesterase inhibitors in the treatment of patients with organic erectile dysfunction: a comparative study].

Currently available three highly selective and effective PDE-5 inhibitors (sildenafil, tadalafil and wardenafil) are comparable by PDE-5 inhibition and selectivity of action on PDE-5 but their differences in activity, interaction with food and alcohol, biological half-life and other characteristics make their use individual for certain clinical situations. Our trial with participation of 575 patients (mean age 57.73 +/- 12.33 years) with arteriogenic erectile dysfunction and great number of vascular risk factors has shown that wardenafil was most popular among our examinees as it is more effective and begins acting faster. Further studies in optimization of the above drugs administration may perfect treatment of erectile dysfuncion.

[Trospium chloride in combined treatment of females with genital prolapse and overactive urinary bladder].

The trial of efficacy of trospium chloride (TC) in a dose of 45 mg/day in females with overactive bladder (OAB) symptoms preserved after genital prolapse (GP) surgical correction included 28 females (age 55-82, mean age 68.07 +/- 12 years). GP was corrected by means of vaginal hysterectomy and anterior colporraphy. Treatment results were assessed 3 months after surgery basing on urine diary. Overall TC efficacy reached 82%. Symptoms attenuated in patients with and without detrusor overactivity: voiding frequency reduced by 31 and 24%, imperative voidings reduced by 26 and 8%, mean urine volume rose by 28 and 19%, respectively. Side effects were mild. TC demonstrated good efficacy in OAB patients, it noticeably improved quality of life.

[Levitra (wardenafil) effects on endothelial function of brachial and cavernous arteries].

We studied effects of oral PDE-5 inhibitor wardenafil (levitra, Bayer & GlaxoSmithKline) on endothelial function of cavernous and brachial arteries in males with normal erectile function and in patients with erectile dysfunction (ED). Endothelial function of the brachial and cavernous arteries was studied in 75 males with ED and 20 healthy volunteers before and after wardenafil intake in a dose 20 mg using ultrasound examination of postcompression diameter changes. The results show that wardenafil improves endothelial function of cavernous and brachial arteries. The degree of the positive effect depends on baseline condition of the endothelial function of the vessels. The highest activity of the drug was seen in patients with arteriogenic ED who had significant decline of endothelial function of both cavernous and brachial arteries. The dependence of wardenafil effect on baseline condition of the endothelial function is confirmed by negative correlation between changes in postcompression artery dilatation after the drug intake and baseline values. This evidences for wardenafil ability to correct disturbed endothelial function of the arteries.

Study of the correlation between clinical efficiency of impaza and serum ADMA level.

Correlation between superlow-dose antibodies to endothelial NO synthase (Impaza) and serum level of ADMA was evaluated in a double blind placebo-controlled study. The reduction of ADMA in patients with erectile dysfunction after impaza treatment was paralleled by improvement of clinical symptoms. No clear-cut correlation between ADMA level and impaza effect was detected.

[Botulinum A toxin in the treatment of patients with detrusor external sphincter dyssynergia and neurogenic low detrusor contractility].

AIM: To investigate safety and efficacy of botulinum A toxin external urethral sphincter injection in the treatment of patients with detrusor external sphincter dyssynergia (DSD) and neurogenic low detrusor contractility (DC). MATERIAL AND METHODS: The study included 21 patients with DSD and 27 patients with low DC between 17 and 73 years of age. The diagnostic scheme consisted of voiding diary for 72 hours, laboratory tests, ultrasound investigation with measurement of residual urine volume, urodynamic investigation and neurologic examination. 100 units of botulinum A toxin (botox, allergan) were injected into external urethral sphincter paraurethrally in women and transurethrally in men. RESULTS: 6 months after the toxin injection good results were achieved in 6 out of 9 DSD patients with spontaneous micturition; physiologic micturition was restored in 5 out of 8 patients who had performed intermittent self catheterization and in 3 out of 4 patients with suprapubic fistula and urethral catheter. As for patients with neurogenic low DC, good results were achieved in 6 of 8 patients who had had spontaneous micturition; physiologic micturition was restored in 13 out of 14 patients who had performed intermittent self catheterization and in 3 out of 5 patients with suprapubic fistula and urethral catheter. There were neither complications nor side effects. CONCLUSION: Botulinum A toxin external urethral sphincter injection demonstrated high efficacy in patients with DSD and neurogenic low DC.

[Etiotropic therapy of chronic bacterial prostatitis].

A total of 20 patients entered the clinical trial of efficacy and safety of Russian produced drug levofloxacin (floracid) in the treatment of chronic bacterial prostatitis (CBP). The drug was given in a single dose of 500 mg/day for 28 days. Antibacterial treatment of CBP with floracid killed sensitive to it bacteria in 18 of 20 (90%) CBP patients. Symptoms of the disease attenuated including pain syndrome and voiding disorders, quality of life assessed by NIH-CPSI scale improved. The absence of side effects points to good tolerance and safety of the drug.

[The pathogenesis of erectile dysfunction in metabolic syndrome].

The aim of the study was to investigate the pathogenesis of erectile dysfunction (ED) in men with metabolic syndrome (MS). The subjects of the study were 385 men with ED and MS and 210 patients with organic ED (control group). The results of a complex clinical and andrological examination demonstrated that the fundamental pathogenetic factor of ED in patients with MS was the alteration of arterial blood circulation in the cavernosal tissue. The most valuable method in the diagnosis of this form of ED was ultrasonographic measurement of postocclusive changes in the diameters of cavernous arteries, reflecting local endothelial function. In addition, in a substantial portion of MS patients, hormonal and neurological disturbances were found, which also contributed to the pathogenesis of ED in this category of patients.

Association between the insertion/deletion polymorphism of the angiotensin-converting enzyme gene and erectile dysfunction in patients with metabolic syndrome.

This study was designed to investigate whether angiotensin-converting enzyme (ACE) insertion/deletion (I/D) polymorphism is associated with erectile dysfunction (ED) in Russian men with metabolic syndrome (MS). A total of 331 men with MS were studied. All patients underwent complex evaluation including the International Index of Erectile Function (IIEF) questionnaire. The ACE I/D polymorphism was determined by polymerase chain reaction. Overall, 182 men (55.0%) had ED according to the IIEF erectile function domain score. In the ED group, the prevalence of DD genotype was found to be significantly higher compared to the non-ED group (P<0.001). In both groups, patients with DD genotype were significantly younger than patients with other genotypes (P<0.001). In addition, in the ED group, the disease affected patients with DD genotype at a significantly younger age (P<0.001). Obtained results give evidence to support the finding that the D allele is a risk factor for the micro- and macrovascular diseases.

[Effects of different treatments on endothelial function in patients with erectile dysfunction and hypogonadism].

AIM: To study effects of different treatments on erectile and endothelial functions in patients with erectile dysfunction (ED) and age-related hypogonadism (HG). MATERIAL AND METHODS: The study included 66 males with ED who had clinical and laboratory signs of HG. All the patients were examined using questionnaires (international index of erectile function, AMS), blood hormones tests. Endothelial function was assessed with postcompression tests on the cavernous arteries and blood homocystein assay. All the patients were divided into two matched groups. Group 1 (20 males, mean age 54.6 +/- 11.5 years) received androgens only, replacement therapy consisted of testosterone undecanoate (Nebido, Shering) 1000 mg each 10-12 weeks intramuscularly, interval between the first and second injection was 6 weeks. Group 2 (46 males, mean age 53.98 +/- 10.03 years) was given combined treatment (androgens and PDE 5 inhibitors), wardenafil (Levitra, Buer Shering Pharma) was used in a dose 20 mg. The treatment lasted 6 months. RESULTS: AMS points decreased in group 1 from 38.3 +/- 0.29 to 29.2 +/- 0.32, in group 2--from 39.02 +/- 0.21 to 28.6 +/- 0.95, while testosterone rose from 9.86 +/- 0.4 to 17.77 +/- 0.42 and 9.35 +/- 0.25 to 17.21 +/- 0.63 nmol, respectively. Homocystein lowering was significantly more manifest in group 2. EF index in group 2 rose from 11.4 +/- 0.77 to 25.54 +/- 0.25 points versus 11.2 +/- 1.01 to 23.95 +/- 0.71 points in group 1, improvement of EF in group 2 occurred sooner. Endothelial function by diameter of the cavernous arteries differed after treatment in group 1 and 2 (19.55 +/- 2.88 to 39.2 +/- 0.84% and 19.51 +/- 1.28 to 48.5 +/- 1.76, respectively, p<0.001). CONCLUSION: Combined therapy improves blood homocistein, acts faster and stronger on endothelial and erectile functions and can be recommended as first line for ED and HG patients.