Reducing Recurrent Urinary Tract Infections in Women with MV140 Impacts Personal Burden of Disease: Secondary Analyses of a Randomized Placebo-controlled Efficacy Study.

Background: Recurrent urinary tract infection (rUTI) remains a major health burden for women. A randomized, double-blind, placebo-controlled trial (RCT; NCT02543827) reported that female patients with rUTI receiving a sublingual vaccine, MV140, had a reduction in rUTI and increase in UTI-free rate compared with placebo. Objective: To determine the impact of MV140 on the personal burden of disease in women with rUTI using secondary endpoint data from the pivotal RCT evaluating MV140. Design setting and participants: In the primary RCT, female patients with rUTI enrolled in Spain and UK (from October 2015 to April 2019) were randomized to placebo (6 mo) or MV140 (3 or 6 mo), and followed for 12 mo. Individuals analyzed in this secondary analysis included those in the placebo and 3-mo (recommended dose) groups. Intervention: A polybacterial sublingual vaccine, MV140 (four inactivated whole-cell bacteria-Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris, and Enterococcus faecalis), or placebo. Outcome measurements and statistical analysis: Symptom severity scoring, antibiotic use, safety, and multiple aspects of quality of life (QoL; Short-Form Questionnaire [SF-36]) were assessed. Results and limitations: Compared with the placebo group (n = 76), the 3-mo vaccinated group (n = 74) experienced fewer overall UTI symptoms (mean symptom score 102.2 ± 222.9 vs 194.2 ± 178.8; p = 0.0002), fewer days on antibiotics (12.4 ± 17.7 vs 28.7 ± 25.2; p = 0.0001), and improved total, general, and physical SF-36 QoL improvement (differences in means for total SF-36 score 15.7; 95% confidence interval [CI] 8.80, 22.64; p < 0.0001), with only social function QoL showing no impact (4.07; 95% CI -4.93, 13.08; p = 0.3744). Conclusions: Three months of MV140 is associated with a reduction of the personal burden of UTI by reducing overall UTI symptoms and antibiotic use, improving QoL in women with rUTI. Patient summary: Three months of MV140 vaccine, which has previously been shown to reduce the risk of urinary tract infection safely, is associated with a reduction in the personal burden of disease.

Overview of seminal fluid biomarkers for the evaluation of chronic prostatitis: a scoping review.

BACKGROUND: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a very common and difficult condition to evaluate, as it is a clinical diagnosis, without a measurable diagnostic "gold standard". The aim of this scoping review is to synthesize all the available data for seminal fluid biomarkers used to assess patients with CP/CPPS. METHODS: A systematic search to identify all relevant publications was conducted on October 22, 2020 across five databases: Ovid Medline, Ovid EMBASE, PubMed, CCRT, and the CINAHL. Two independent authors screened all articles and extracted relevant data. RESULTS: A total of 27 articles met the eligibility criteria. A majority of studies were case-control (15), with 6 observational cohorts and 6 comparative interventional studies. The total number of pooled patients included 585 patients with CP/CPPS (unspecified subtype), 371 patients with inflammatory CP/CPPS, 387 patients with non-inflammatory CP/CPPS, 354 patients with chronic bacterial prostatitis, and 432 healthy controls. Inflammatory seminal biomarkers were the most frequently studied, with IL6, IL8, TNFα and IL1ß being the most promising candidates. CONCLUSIONS: There are a number of very promising seminal biomarkers to help categorize and monitor therapies in CP/CPPS. Large multicentre studies using a shared protocol for measuring seminal biomarkers with the primary intention of biomarker validation are needed prior to clinical implementation. Identification of biomarker(s) will facilitate the etiological categorization of patients with chronic prostatitis and provide an objective framework to tailor specific therapies according to the biomarker family.

Impact of 5α-reductase inhibitor and α-blocker therapy for benign prostatic hyperplasia on prostate cancer incidence and mortality.

OBJECTIVE: To investigate the use of 5α-reductase inhibitors (5ARIs) and α-blockers among men with benign prostatic hyperplasia (BPH) in relation to prostate cancer (PCa) incidence, severity and mortality. PATIENTS AND METHODS: A retrospective 20-year cohort study in men residing in Saskatchewan, aged 40-89 years, with a BPH-coded medical claim between 1995 and 2014, was conducted. Cox proportional hazards regression was used to compare incidence of PCa diagnosis, metastatic PCa, Gleason score 8-10 PCa, and PCa mortality among 5ARI users (n = 4 571), α-blocker users (n = 7 764) and non-users (n = 11 677). RESULTS: In comparison with both non-users and α-blocker users, 5ARI users had a ~40% lower risk of a PCa diagnosis (11.0% and 11.4% vs 5.8%, respectively), and α-blocker users had an 11% lower risk of a PCa diagnosis compared with non-users. Overall, the incidence of metastatic PCa and PCa mortality was not significantly different among 5ARI or α-blocker users compared with non-users (adjusted hazard ratios [HR] of metastatic PCa: 1.12 and 1.13, respectively, and PCa mortality: 1.11 and 1.18, respectively, P > 0.05 for both drugs), but both 5ARI and a-blocker users had ~30% higher risk of Gleason score 8-10 cancer, adjusted HR 1.37, 95% confidence interval [CI] 1.03-1.82, P = 0.03, and adjusted HR 1.28, 95% CI 1.03-1.59, P = 0.02, respectively compared with non-users. CONCLUSION: The use of 5ARIs was associated with lower risk of PCa diagnosis, regardless of comparison group. Risk of high grade PCa was higher among both 5ARI users and α-blocker users compared with non-users; however, this did not translate into higher risk of PCa mortality.

Mechanisms of Quality of Life and Social Support in Inflammatory Bowel Disease.

Cognitive and social factors are essential considerations in inflammatory bowel disease (IBD) patient management, but existing research is limited. This study aims to expand the IBD literature by examining the relationship between social supports and QoL, while examining mechanisms in these relationships. Consenting patients attending an IBD outpatient clinic were provided a survey package (N = 164). Regressions evaluated predictors of IBD-QoL, and catastrophizing and optimism were examined as mediators between social support and IBD-QoL. Diminished IBD-QoL was predicted by younger age, greater negative spousal responses, and less perceived spousal support. Mediation models showed helplessness catastrophizing to be the lone mediator, acting as a mechanism between both negative spousal responses and perceived spousal support with IBD-QoL. Social interaction variables are associated with IBD-QoL, but patients' experience of helplessness acts to reduce their ability to benefit from social support. Patient care should consider supportive social and cognitive factors to improve IBD-QoL.

Multiple sensitivity phenotype in interstitial cystitis/bladder pain syndrome.

INTRODUCTION: Phenotypic differentiation of patients with interstitial cystitis/bladder pain syndrome (IC/BPS) may improve our understanding of the condition, as well as the development of patient-specific treatment strategies. We identified a distinct subgroup of IC/BPS patients with a multiple sensitivity phenotype. METHODS: We defined patients with this IC/BPS associated multiple sensitivity syndrome as having at least 3 confirmed allergies/sensitivities to medications and/or environmental factors and a diagnosis of IC/BPS. These IC/BPS patients identified with a multiple sensitivity phenotype (cases) were compared to age-matched IC/BPS patients with few or no allergies (controls) at a 1:2 ratio. Comparisons were undertaken using standardized case assessment parameters (age, duration of symptoms, medical history, Interstitial Cystitis Symptoms Index [ICSI] and pelvic pain and urinary urgency/frequency [PUF] symptom scores, and urinary, psychosocial, organ specific, infection, neurologic/systemic, tenderness [UPOINT] categorization). RESULTS: The study consisted of 17 cases and 34 age-matched controls; the mean age was 55 and 56 years, respectively. There was statistically more medication and environmental allergies in the cases versus controls. Cases reported more concomitant illnesses (9.6 vs. 6.2, p < 0.001) and number of bodily systems affected (6.0 vs. 3.8, p ≤ 0.001). The prevalence of irritable bowel syndrome and fibromyalgia was higher in the case group (p = 0.028, p ≤ 0.001, respectively). Additionally, there were more reported psychiatric diseases (p = 0.019), allergic/immune diseases (p = 0.003), and pulmonary diseases (p < 0.001) in the case group. UPOINT classification differed with more patients in the case group being categorized in the psychosocial and neuropathic/systemic domains (p = 0.045, p = 0.007, respectively). Total UPOINT classification (out of 6) was also higher in cases than controls (4.6 vs. 3.2, p = 0.001, respectively). CONCLUSIONS: We have characterized a distinct phenotypic group of patients with IC/BPS and multiple sensitivities. The limitations of our study include the retrospective case-control matching design, biases in phenotype definition, single centre patient recruitment, and the lack of follow-up. Nonetheless, the observation of this specific phenotype suggests that further research in this group may help develop targeted therapeutic strategies for patients with a concomitant multiple sensitivity syndrome and IC/BPS.

Nutraceuticals in Prostate Disease: The Urologist's Role.

Interest in and use of complementary and alternative therapies, especially nutraceuticals, is high in prostate disease. These therapies have shown potential in benign prostatic hyperplasia (BPH), prostatitis, and prostate cancer. Some have produced results equal to or better than pharmaceuticals currently prescribed for BPH. In category III prostatitis, some nutraceuticals may offer relief to patients who get little from standard therapy. Because it is becoming apparent that inflammation may play a role in the progression of BPH and development of prostate cancer, nutraceuticals, which commonly have anti-inflammatory properties, may play a role. These therapies have also shown potential in prostate cancer treatment and prevention, especially those that also reduce cardiovascular events or risk. Nevertheless, uses of some nutraceuticals in prostate disease have had less desirable consequences, showing lack of efficacy, adulteration, and/or severe side effects or drug interactions. By ensuring that these therapies undergo careful study for effectiveness, quality, and safety, urologists can look forward to adding them to their evidence-based armamentarium for prostate disease.

Management of men diagnosed with chronic prostatitis/chronic pelvic pain syndrome who have failed traditional management.

For many patients, the traditional biomedical model that physicians have used to manage chronic prostatitis does not work. This article describes innovative treatment strategies for chronic prostatitis/chronic pelvic pain syndrome, with an emphasis on novel biomedical physical therapy and biopsychosocial approaches to the management of individualized patient symptoms.

Predictors of quality of life and pain in chronic prostatitis/chronic pelvic pain syndrome: findings from the National Institutes of Health Chronic Prostatitis Cohort Study.

OBJECTIVES: To examine the cross-sectional relationship of age, urinary and depressive symptoms and partner status on pain intensity and quality of life (QoL) in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). PATIENTS AND METHODS: In all, 463 men enrolled in the National Institutes of Health (NIH) Chronic Prostatitis Cohort Study from seven clinical centres (six in the USA and one in Canada) reported baseline screening symptoms using the NIH Chronic Prostatitis Symptom Index (CPSI). The CPSI provides scores for pain, urinary symptoms and QoL. In addition, a demographic profile, including age and partner (living with another) status, and a depressive symptom score were obtained. Regression modelling of QoL, adjusting for between-centre variability, examined the unique effects of age, partner status, urological symptoms, depressive symptoms and pain. RESULTS: Urinary scores, depressive symptoms and pain intensity scores significantly predicted QoL for patients with CP/CPPS (higher CPSI QoL scores indicated more impairment; median 8.0, range 0-12). On average, for every 1-point increase in urinary scores, there was a corresponding increase in QoL score of 0.118 points (P = 0.001); for every 1-point increase in pain intensity score, there was a corresponding increase in QoL score of 0.722 points (P < 0.001); and for every 1-point decrease in depressive symptoms (lower scores equal poorer mood), the QoL score increased (poorer quality of life) by 0.381 points (P < 0.001). Age and partner status did not significantly contribute to poorer QoL. Urinary scores and depressive symptoms were significant predictors (P < 0.001) of pain in patients with CP/CPPS. CONCLUSIONS: These data show that depressive symptoms and pain intensity significantly predict a poorer QoL in patients with CP/CPPS, and that these effects are independent of partner status, age and urinary status. In particular, pain intensity was the most robust predictor of a poorer QoL. Further data relating pain and psychological factors to CP/CPPS are highly recommended, to aid in determining specific factors for pain and its impact on QoL. These data are essential if empirically guided efforts to manage pain are to progress.