ObjectivesTo compare the clinical effectiveness of the intravesical administration of combined hyaluronic acid and chondroitin sulfate (HA+CS) versus current standard management in adult women with recurrent urinary tract infections (RUTIs).SettingA European Union-based multicentre, retrospective nested case–control study.Participants276 adult women treated for RUTIs starting from 2009 to 2013.InterventionsPatients treated with either intravesical administration of HA+CS or standard of care (antimicrobial/immunoactive prophylaxis/probiotics/cranberry).Primary and secondary outcome measuresThe primary outcome was occurrence of bacteriologically confirmed recurrence within 12 months. Secondary outcomes were time to recurrence, total number of recurrences, health-related quality of life and healthcare resource consumption. Crude and adjusted results for unbalanced characteristics are presented.Results181 patients treated with HA+CS and 95 patients treated with standard of care from 7 centres were included. The crude and adjusted ORs (95% CI) for the primary end point were 0.77 (0.46 to 1.28) and 0.51 (0.27 to 0.96), respectively. However, no evidence of improvement in terms of total number of recurrences (incidence rate ratio (95% CI), 0.99 (0.69 to 1.43)) or time to first recurrence was seen (HR (95% CI), 0.99 (0.61 to 1.61)). The benefit of intravesical HA+CS therapy improves when the number of instillations is ≥5.ConclusionsOur results show that bladder instillations of combined HA+CS reduce the risk of bacteriologically confirmed recurrences compared with the current standard management of RUTIs. Total incidence rates and hazard rates were instead non-significantly different between the 2 groups after adjusting for unbalanced factors. In contrast to what happens with antibiotic prophylaxis, the effectiveness of the HA+CS reinstatement therapy improves over time.Trial registration numberNCT02016118.
ObjectiveTo determine the relationship between lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH) and 10-year risk of cardiovascular disease (CVD) assessed by the Framingham CVD risk score in a cohort of patients without previous episodes of stroke and/or acute myocardial infarction. Patients and MethodsFrom September 2010 to September 2014, 336 consecutive patients with BPH-related LUTS were prospectively enrolled. The general 10-year Framingham CVD risk score, expressed as percentage and assessing the risk of atherosclerotic CVD events, was calculated for each patient. Individuals with low risk had ≤10% CVD risk at 10 years, with intermediate risk 10-20% and with high risk ≥20%. Logistic regression analyses were used to identify variables for predicting a Framingham CVD risk score of ≥10% and moderate-severe LUTS (International Prostate Symptom Score [IPSS] ≥8), adjusted for confounding factors. ResultsAs category of Framingham CVD risk score increased, we observed higher IPSS (18.0 vs 18.50 vs 19.0; P < 0.05), high IPSS-voiding (6.0 vs 9.0 vs 9.5; P < 0.05) and worse sexual function. Prostate volume significantly increased in those with intermediate-vs low-risk scores (54.5 vs 44.1 mL; P < 0.05). Multivariate logistic regression analysis showed that intermediate-[odds ratio (OR) 8.65; P < 0.01) and high-risk scores (OR 1.79; P < 0.05) were independently associated with moderate-severe LUTS. At age-adjusted logistic regression analysis, moderate-severe LUTS was independently associated with Framingham CVD risk score of ≥10% (OR 5.91; P < 0.05). ConclusionOur cross-sectional study in a cohort of patients with LUTS-BPH showed an increase of more than five-fold of having a Framingham CVD risk score of ≥10% in men with moderate-severe LUTS.
BACKGROUND. Phytotherapy has been used to treat patients with lower urinary tract symptoms (LUTS). We evaluated the efficacy and tolerability of combination therapy between Serenoa Repens (SeR), Lycopene (Ly), and Selenium (Se) þ tamsulosin versus single therapies. METHODS. PROCOMB trial (ISRCTN78639965) was a randomized double-blinded, doubledummy multicenter study of 225 patients between 55 and 80 years old, PSA 4 ng/ml, IPSS !12, prostate volume 60 cc, Qmax 15 ml/sec, postvoid residual urine (PVR) <150 ml. Participants were randomized group A (SeR-Se-Ly), group B (tamsulosin 0.4 mg), group C (SeR-Se-Ly þ tamsulosin 0.4 mg). The primary endpoints of the study were the reduction of IPSS, PVR, and increase of Qmax in group C versus monotherapy groups. RESULTS. The decrease for combination therapy was significantly greater versus group A (P < 0.05) and group B (P < 0.01) for IPSS and versus group A (P < 0.01) for PVR from baseline This study has been designed and conducted independently. Konpharma provided support for this study. Data collection and management and all statistical analyses were performed and retained by data manager (R.A.). The corresponding author and other co-authors interpreted the data and participated in the preparation, review and approval of the manuscript. to 6 months. A greater decrease in IPSS was observed for Group C versus group A (P < 0.01) and increase in Qmax versus group B (P < 0.01), from 6 months to 12 months. At one year, the changes of IPSS and Qmax were greater for Group C versus monotherapies (each comparison <0.05). The proportions of men with a decrease of at least three points (each comparison P < 0.05) and decrease of 25% for IPSS (each comparison P < 0.01) were greater for Group C. CONCLUSION. SeR-Se-Ly þ tamsulosin therapy is more effective than single therapies in improving IPSS and increasing Qmax in patients with LUTS.
Introduction Several studies have linked the association between lower urinary tract symptoms (LUTS), erectile dysfunction (ED), and the presence of insulin resistance (IR) due to an underlined metabolic syndrome (MetS). Aim This study aims to determine the relationship between IR, sexual function, and LUTS and to demonstrate the ability of IR in predicting ED and severe LUTS. Methods Between January 2008 to January 2013, 544 consecutive patients with benign prostatic hyperplasia-related LUTS were enrolled. LUTS and sexual function of the patients were evaluated by the International Index of Erectile Function (IIEF) and the International Prostate Symptom Score (IPSS). MetS was defined by the International Diabetes Federation. IR was defined as a homeostasis model assessment (HOMA) index of 3 or greater. Main Outcome Measures Uni- and multivariate logistic regression analysis was performed to assess significant predictors of severe LUTS (IPSS ≥20) and ED (IIEF-Erectile Function [IIEF-EF] <26), including MetS component, prostate volume, prostate-specific antigen, total testosterone, and HOMA index. Results IR patients resulted in higher values of IPSS (19.0 vs. 15.0; P < 0.01), IPSS-storage (6.0 vs. 5.0; P < 0.01), IPSS-voiding (12.0 vs. 9.0; P < 0.01), total prostate volume (54.8 vs. 36.5; P < 0.01), and lower values of IIEF-EF (17.0 vs. 20.0; P < 0.01), IIEF-Intercourse Satisfaction (3.0 vs. 10.0; P < 0.01), IIEF-Orgasmic Function (8.0 vs. 9.0; P < 0.01), IIEF-Overall Satisfaction (6.0 vs. 8.0; P < 0.01), and total testosterone (3.83 vs. 4.44; P < 0.01). IR was demonstrated to be a strong predictor of ED (IIEF-EF <26) (odds ratio [OR] = 6.20, P < 0.01) after adjusting for confounding factors. Finally, IR was also an independent predictor of severe LUTS (IPSS ≥20) (OR = 2.0, P < 0.01) after adjusting for confounding factors. Conclusions IR patients are at high risk of having severe LUTS and contemporary sexual dysfunctions. We strongly suggest to prevent LUTS and ED by reducing insulin resistance.
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