Improvement of Urinary Tract Symptoms and Quality of Life in Benign Prostate Hyperplasia Patients, Associated with Consumption of a Newly Developed whole Tomato Based Food Supplement. A phase II prospective, Randomized Double-blinded, Placebo-controlled Study.
Luigi CormioBeppe CalòManuela IezziAlessia LamolinaraPaola VitaglioneGiovanni SilecchiaGiuseppe CarrieriVincenzo FoglianoStefano IacobelliPier Giorgio NataliMauro Piantelli
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Abstract Background: Benign prostatic hyperplasia is the most common urologic disease among elderly men. The diagnosis of BPH is usually in response to the appearance of lower urinary tract obstructive, and post-micturition symptoms (LUTS) that can significantly affect the quality of life. In Aim of this study was to evaluate in a phase II prospective, randomized double-blinded, placebo-controlled study, the efficacy and safety of a novel whole tomato-based food supplement on LUTS of patients affected by benign prostatic hyperplasia. Methods: Thirty-four consecutive patients with histologically proved BPH were included in a phase II prospective, randomized double-blinded, placebo-controlled study. Patients were randomized to receive daily for two months a sachet (5 grams) of the tomato-based food supplement Lycoprozen® or an identical sachet containing placebo. Patients were asked to fill the “International Prostatic Symptom Score” questionnaire before and after treatment. Results: All patients successfully completed the scheduled regimen. No side effects were recorded. Lycoprozen® significantly reduced the LUTS severity. Particularly, the IPSS mean values before and after the treatment were 7.5 + 1.1 SE (range 16-2) and 5.1 + 1.0 SD (range 14-2), respectively (paired t-test, two-tailed p value <0.0002). A trend toward a reduction of total PSA levels was observed in Lycoprozen® treated patients (9.346 ng/ml + 1.839 SE vs.7.906 + 0.928 SE, P = 0.096) (Fig 1, left). This trend was sustained by the significant reduction of PSA levels seen in 5 patients, (2 obese, 2 over-weight and 1 normal-weight) with basal levels >10 ng/ml (18.520ng/ml + 2.747 SE vs. 10.323ng/ml + 2.073 SE, P = 0.009)Keywords:
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The purpose of the study is to study the efficacy and safety of the prostate extract (GEROFARM LLC, Russia) in the postoperative period in patients after transurethral bipolar resection of the prostate.The clinical study included 127 men aged 50 to 78 years with grade II benign prostatic hyperplasia (adenoma) who underwent a typical bipolar transurethral resection of the prostate. Patients of the main (n=60) group received tamsulosin 0.4 mg/day for 30 days in the postoperative period in combination with prostate extract 10 mg rectally for 21 days. In the control group (n=67) - tamsulosin 0.4 mg/day for 30 days as monotherapy. To assess the results of treatment, the questionnaire of the international system of total assessment of symptoms in prostate diseases (IPSS) with the definition of quality of life (QoL), the international index of erectile function (IIEF-5) and uroflowmetry were used. The control was carried out in terms of 1 and 3 months after the operation.In the main group, in the observation period of 1 and 3 months after the operation, a decrease in the average IPSS score by 40.2% and 52.9% was revealed, and an improvement in the quality of life by 45% and 64.7%, respectively, was noted. In the control group, at the same time of observation, a decrease in the average IPSS score by 34% and 44.7%, respectively, was revealed, and the quality of life improved by 25.5% and 37.3%, respectively. The increase in the average rate of urination in the main group by the end of 1 and 3 months of treatment was 59.2% and 85.7%, respectively, and in the control group, these figures were 40.5% and 50%. The positive effect of the proposed combination therapy on erectile function in the main group by the end of 1 and 3 months of treatment was 5.2% and 9.2%, respectively, and in the control group, these figures were 2.9% and 5.2%.There is a significant decrease in the symptoms of the lower urinary tract in the group of patients who received the drug Prostateks (GEROFARM LLC, Russia).The efficacy results of Prostatex (GEROFARM LLC, Russia) (reduced symptom severity on IPSS (11.7 1.2 ) and QoL (2.3 0.3)) scales are comparable to those of Vitprost Plus which allows you to evaluate the effectiveness of two drugs equally.
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Objective To investigate changes in symptoms and quality of life (QOL) score before and after transurethral resection of the prostate ( TURP), and their related factors. Methods Forty-seven elderly male patients of benign prostate hyperplasia (BPH) with lower urinary tract symptoms were enrolled in the study, with an average age of 72 years. They all were undergone with TURP and evaluated with international prostate symptoms score (IPSS), QOL score, maximal urine flow rate (Qmax), residual urine volume, pressure-urine flow rate and prostate size before and after the procedure. Changes in these parameters and their related factors were analyzed. Results No complication was observed during TURP in the 47 patients. After TURP, two patients suffered from distal urethra stricture, one from retrograde ejaculation and six from aggravated urgent incontinence, and symptoms relieved with symptomatic treatment in all of them. Significant difference in overall IPSS, irritant score and obstructive score pre- and post-operation was observed P ＜ 0.01, i. e. , 22.7 ±4.9 and 10.5 ± 5.8, 10.5 ± 5.8 and 6.3 ± 3.5, and 12.1± 3.9 and 4.2 ± 3.3, respectively. QOL score was 4.6 ± 0.9 and 2.3 ± 1.3, Qmax (5.8 ± 2.9 ) ml/s and (12.4 ±5.2) ml/s and residual urine volume (99 ± 16) ml and (34 ± 19) ml pre- and post-operation,respectively ( all P ＜ 0.01 ). Follow-up time after the procedure, prostate volume and bladder volume at urgent urination desire all correlated with post-operation IPSS ( r = 0.751, P ＜ 0.05 ), and follow-up time after the procedure and age also significant correlated with post-operation QOL score (r = 0.470, P ＜ 0.05 ).Conclusions Overall IPSS, irritant score, obstructive score and QOL score improved significantly after TURP in symptomatic BPH patients, probably by varied related factors.
Key words:
Lower urinary tract symptoms; Transurethral resection of prostate; Quality of life
Retrograde ejaculation
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Objective To explore the safety and efficacy of transurethral vaporization of the prostate for benign prostatic hyperplasia with high-risk.Methods Transurethral vaporization of the prostate was performed in 90 patients with high risk of prostate hyperplasia.Results The average operating time was 54 minutes.All patients were safe in the perioperative period.The catheter was pulled away at 4 to 5 days after operation.88 cases got unobstructed micturition,2 cases received the indwelling urethral catheter again after the first catheterization because of the urination difficulties.No case of urinary incontinence and death was found.A follow-up of 2 to 24 months showed that the international prostate symptom score(IPSS) decreased from 31.2 to 8.6 points,and the score of the quality of life(QOL) decreased from 5.5 to 2.0 points.Conclusions Transurethral vaporization of the prostate is safe and effective with fewer complications for high-risk benign prostatic hyperplasia.
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Removal of infravesicular obstruction by transurethral resection (TUR) of the prostate rapidly eradicates obstructive symptoms but irritative symptoms persist. We studied the effect of alpha 1-adrenoblockers (A1AB) in respect of optimization of TUR effects. The trial was performed in 1998-2002 and included 197 patients treated surgically (TUR) for benign prostatic hyperplasia (BPH). 96 patients received no A1AB in the postoperative period (group 1). 52 patients took terazosine (group 2) and 49 patients were given tansulosine (group 3). IPSS symptoms and QoL estimation were registered monthly, the patients recorded the urination. After 3 and 6 months after TUR, maximal urination rate (MUR) and residual urine were assessed. It was found that MUR and QoL did not differ significantly between the groups but in groups 2 and 3 a fall in the overall score by IPSS was greater. The positive symptomatic improvement was achieved due to relief of the symptoms of urinary bladder filling corresponding to an increase in physiological capacity of the organ, the difference being significant (p < 0.05).
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Objective:To evaluate the effect and safety of surgical treatment of transurethral plasmakinetic resection of prostate (TUPKVP)in advanced age and danger of benign prostatic hyperplasia (BPH) patients.Methods:61 cases of BPH were treated by transurethral plasmakinetic resection of prostate (TUPKVP).Results:The mean prostatic weight was 53 g and blood loss 30 to 100 ml.No TURS and no real urinary incontinence and no blood transfusion.All cases obtained un obstructed micturition after treatment.Following up 3 to 12 months,their international prostate symptom score (IPSS) were significantly improved by TUPKVP.Conclusion:TUPKVP is a safe and effective way in the treatment of advanced age and danger benign prostatic hyperplasia(BPH) patients.
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Nocturia
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Objective To observe the curative effect of selective α1 receptor inhibitor(cardura xl)on patients′ early micturition condition after transurethral resection of prostate.Methods 104 cases of benign prostatic hyperplasia patients admitted to our hospital from September 2010 to August 2012 were divided into treatment group and control group randomly,52 cases in each group.After operation,treatment group took selective α1 receptor inhibitor(cardura xl),while control group took placebo.The two groups′ postoperative micturition condition was observed.Results There were significant differences between the two groups in maximum flow rate,bladder residual urine output(B ultrasonic detection)and IPSS score after operation;treatment group′s average score was higher than that of control group(P0.05);there were 47 cases of patients in treatment group whose postoperative recovery was good,the percentage was 90.4%,while there were 34 cases(65.4%)in control group,treatment group′s postoperative recovery degree was better than that of control group(P0.05).Conclusion Selective α1 receptor inhibitor has significant improving effect on patients′ early micturition condition after transurethral resection of prostate.
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We evaluated the correlation between benign prostate hyperplasia (BPH) measures and diabetes mellitus in men with benign prostate hyperplasia in a prospective study.Between 2008-2012, 100 diabetic and 200 non diabetic patients undergoing surgery due to benign prostate hyperplasia were enrolled in the study. The parameters evaluated for each patients included prostate volume, fasting blood glucose, HbA1c, total testosterone, total prostatic specific antigen (T-PSA), triglicerides, total cholesterol and body mass index (BMI). A questionnaire including international prostate symptom score (IPSS) was sdministered and uroflow test measuring the peak urinary flow rate was performed to appreciate the complaints of the patients objectively.Diabetic patients are more likely to have larger prostate volume. The symptom score evaluated by IPSS and post micturition residual volume were also significantly higher in diabetic groups. The other statistically significant different parameter between two groups was total testosterone that diabetic patients tend to have lower levels. Diabetic counterparts were established to have higher BMI. No statistically significant differentiation was observed about trigliceryde and total cholesterol levels and uroflow rates.Our study suggests a positive correlation between high prostate volume and diagnosis of diabetes mellitus in patients with benign prostatic hyperplasia. We also observed a positive correlation between symptom scores and post micturion residual volumes and diagnosis of diabetes mellitus suggesting that the presence of diabetes is related to both static and dynamic components of benign prostate hyperplasia. Additionally testosterone levels were lower in diabetic patients. Further studies need to confirm these relationship in a larger population.
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