The occurrence of urolithiasis in the United States has increased, however, information on long-term trends, including recurrence rates, is lacking. Here we describe national trends in rates of emergency department visits, use of imaging, and drug treatment primarily using the National Hospital Ambulatory Medical Care Surveys to describe trends and the National Health and Nutrition Examination Survey to determine the frequency of lifetime passage of kidney stones. Emergency department visit rates for urolithiasis increased from 178 to 340 visits per 100,000 individuals from 1992 to 2009. Increases in visit rates were greater in women, Caucasians and in those 25–44 years of age. The use of computed tomography in urolithiasis patients more than tripled, from 21% to 71%. Medical expulsive therapy was used in 14% of patients with a urolithiasis diagnosis in 2007–2009. Among National Health and Nutrition Examination Survey participants who reported a history of kidney stones, 22.4% had passed three or more stones. Hence, emergency department urolithiasis visit rates have increased significantly, as has the use of computed tomography in the United States. Further research is necessary to determine whether recurrent stone formers receive unnecessary radiation exposure during diagnostic evaluation in the emergency department, and allow development of corresponding evidence-based guidelines.
Computed Tomography; Radiation; NHAMCS
To estimate the effect of a decrease in urinary incontinence frequency on urinary incontinence management costs among women enrolled in a clinical trial of a weight loss intervention and to identify factors that predict change in cost.
This is a secondary cohort analysis of 338 obese and overweight women with ≥ 10 weekly episodes of urinary incontinence enrolled in an 18-month randomized clinical trial of a weight loss intervention compared to a structured education program to treat urinary incontinence. Quantities of resources used for incontinence management, including pads, additional laundry, and dry cleaning were reported by participants. Direct costs for urinary incontinence management (“cost”) were calculated by multiplying resources used by national resource costs (in 2006 U.S. dollars). Randomized groups were combined to examine the effects of change in incontinence frequency on cost. Possible predictors of change in cost were examined using generalized estimating equations controlling for factors associated with change in cost in univariable analyses.
Mean (±SD) age was 53±10 years and baseline weight was 97+17 kg. Mean weekly urinary incontinence frequency was 24+18 at baseline and decreased by 37% at 6 months and 60% at 18 months follow-up (both P<0.001). At baseline, adjusted mean cost was $7.76±$14 per week, with costs increasing significantly with greater incontinence frequency. Mean cost decreased by 54% at 6 months and 81% at 18 months (both P<0.001). In multivariable analyses, cost independently decreased by 23% for each decrease of seven urinary incontinence episodes per week and 21% for each 5 kg of weight lost (P<0.001 for both).
In obese and overweight women enrolled in a clinical trial of weight loss for urinary incontinence, incontinence management cost decreased by 81% at 18 months ($327 per woman per year) and was strongly and independently associated with decreasing incontinence frequency.
To examine pre-and post-operative patient-related factors associated with continence status up to 7 years post-surgery for stress urinary incontinence (SUI).
Materials and Methods
Women randomized to Burch colposuspension or fascial sling surgery and assessed for the primary outcome of urinary continence two years post-procedure were eligible to enroll in a prospective observational study. Survival analysis was used to investigate baseline and post-surgery factors on subsequent risk of SUI defined as self-report of SUI symptoms, incontinence episodes on a 3-day diary or surgical retreatment.
Seventy four percent (482/655) of women who participated in the randomized trial were enrolled in the follow-up study. Urinary continence rates decreased over a period of two to seven years post-operatively from 42% to 13% in the Burch group and from 52% to 27%, in the sling group, respectively. Among the baseline factors included in the first multivariable model age (p=0.03) prior SUI surgery (p=0.02), menopausal status (0.005), urge index (0.006), assigned surgery (p=0.01) and recruiting site (p=0.02) were independently associated with increased risk of incontinence. In the final multivariable model including baseline and post-operative factors, Burch surgery (p=0.01), baseline variables of prior UI surgery (p=0.04), menopausal status (p=0.03) and post-surgery urge index (p<0.001), were each significantly associated with greater risk of recurrent urinary incontinence.
Pre- and postoperative urgency incontinence symptoms, Burch urethropexy, prior SUI surgery and menopausal status were negatively associated with long-term continence rates. More effective treatment of urgency UI in patients who undergo SUI surgery may improve long-term overall continence status.
Stress urinary incontinence; urgency urinary incontinence; surgical outcomes
Retinal vascular and anatomic abnormalities caused by diabetes, hypertension, and other conditions can be observed directly in the ocular fundus and may reflect severity of chronic renal insufficiency. The purpose of this study was to investigate the association between retinopathy and chronic kidney disease (CKD).
In this observational, cross-sectional study, 2605 participants of the Chronic Renal Insufficiency Cohort (CRIC) study, a multi-center study of CKD, were offered participation. Non-mydriatic fundus photographs of the disc and macula in both eyes were obtained in 1936 of these subjects.
Photographs were reviewed in a masked fashion at a central photograph reading center using standard protocols. Presence and severity of retinopathy (diabetic, hypertensive or other) and vessel diameter caliber were assessed by trained graders and a retinal specialist using protocols developed for large epidemiologic studies. Kidney function measurements and information on traditional and non-traditional risk factors for decreased kidney function were obtained from the CRIC study.
Greater severity of retinopathy was associated with lower estimated glomerular filtration rate (eGFR) after adjustment for traditional and non-traditional risk factors. Presence of vascular abnormalities usually associated with hypertension was also associated with lower eGFR. We found no strong direct relationship between eGFR and average arteriolar or venular calibers.
Our findings show a strong association between severity of retinopathy and its features and level of kidney function after adjustment for traditional and non-traditional risk factors for CKD, suggesting that retinovascular pathology reflects renal disease.
Retinopathy; Retinal Vascular Diameter; Chronic Kidney Disease
Depressive symptoms are correlated with poor health outcomes in adults with chronic kidney disease (CKD). The prevalence, severity, and treatment of depressive symptoms and potential risk factors, including level of kidney function, in diverse populations with CKD have not been well studied.
Settings and Participants
Participants at enrollment into the Chronic Renal Insufficiency Cohort (CRIC) and Hispanic-CRIC (H-CRIC) Studies. CRIC enrolled Hispanics and non-Hispanics at seven centers from 2003-2007, and H-CRIC enrolled Hispanics at the University of Illinois from 2005-2008.
Depressive symptoms measured by Beck Depression Inventory (BDI)
Demographic and clinical factors
Elevated depressive symptoms (BDI >= 11) and antidepressant medication use
Among 3853 participants, 28.5% had evidence of elevated depressive symptoms and 18.2% were using antidepressant medications; 30.8% of persons with elevated depressive symptoms were using antidepressants. The prevalence of elevated depressive symptoms varied by level of kidney function: 25.2% among participants with eGFR ≥ 60 ml/min/1.73m2, and 35.1% of those with eGFR < 30 ml/min/1.73m2. Lower eGFR (OR per 10 ml/min/1.73m2 decrease, 1.09; 95% CI, 1.03-1.16), Hispanic ethnicity (OR, 1.65; 95% CI, 1.12-2.45), and non-Hispanic black race (OR, 1.43; 95% CI, 1.17-1.74) were each associated with increased odds of elevated depressive symptoms after controlling for other factors. In regression analyses incorporating BDI score, while female sex was associated with a greater odds of antidepressant use, Hispanic ethnicity, non-Hispanic black race, and higher levels of urine albumin were associated with decreased odds of antidepressant use (p<0.05 for each).
Absence of clinical diagnosis of depression and use of non-pharmacologic treatments
Although elevated depressive symptoms were common in individuals with CKD, use of antidepressant medications is low. African Americans, Hispanics, and individuals with more advanced CKD had higher odds of elevated depressive symptoms and lower odds of antidepressant medication use.
This post hoc analysis of the Medical Therapy of Prostatic Symptoms (MTOPS) trial examined the effect of finasteride alone compared to placebo on clinical progression of benign prostatic hyperplasia (BPH) in men with baseline prostate volume (PV) <30 mL and ≥30 mL.
Materials and Methods
Men were randomized to placebo (n=737), doxazosin alone (4 to 8 mg) (n=756), finasteride alone (5 mg) (n=768), or doxazosin plus finasteride (n=786) (average duration of follow-up was 4.5 yrs); ~50% of patients had a baseline PV ≥30 mL. The present analysis was based on the finasteride alone and placebo arms only and included patients for whom baseline and end of study data were available. We examined the effect of treatment on the cumulative percentage of men who did not experience clinical progression of BPH by study end.
In men with baseline PV ≥30 mL, treatment with finasteride produced a significant (p<0.001) increase relative to placebo in the cumulative percentage of patients who did not experience clinical progression of BPH (finasteride, 88.1%, versus placebo, 77.8%). There was no significant (p=0.441) between-group difference in men with baseline PV <30 mL (91.4% versus 89.1%, respectively).
Long-term treatment with finasteride led to a significant beneficial effect compared to placebo on clinical progression of BPH in LUTS patients with enlarged prostates (baseline PV ≥30 mL). Finasteride had no significant effect, compared to placebo on clinical progression of BPH in LUTS patients with smaller prostates (baseline PV <30 mL).
benign prostatic hyperplasia; lower urinary tract symptoms; finasteride; total prostate volume
We conducted a 2-stage, multicenter, double-blind, randomized phase II clinical trial of 100 and 300 unit doses of onabotulinum toxin A to treat the lower urinary tract symptoms of benign prostatic hyperplasia.
Materials and Methods
Men 50 years old or older with clinically diagnosed benign prostatic hyperplasia, American Urological Association symptom index 8 or greater, maximum urinary flow rate less than 15 ml per second, voided volume 125 ml or greater, and post-void residual 350 ml or less were randomized to prostatic transrectal injection of 100 or 300 units of onabotulinum toxin A. The primary outcome was at least 30% improvement from baseline to 3 months in American Urological Association symptom index and/or maximum urinary flow rate and safety. The men were followed for 12 months.
A total of 134 men were randomized and treated (68 with 100 units, 66 with 300 units), with 131 assessed at 3 months and 108 assessed at 12 months. Each dose met the 3-month primary outcome criteria. In the 100 unit arm the mean baseline American Urological Association symptom index of 18.8 decreased by 7.1 and 6.9 at 3 and 12 months, respectively. In the 300 unit arm the baseline of 19.5 decreased by 8.9 and 7.1, respectively. In the 100 unit arm the mean baseline maximum urinary flow rate of 10.0 ml per second increased by 2.5 and 2.2, respectively, and in the 300 unit arm the baseline of 9.6 increased by 2.6 and 2.3, respectively.
The intraprostatic injection of 100 or 300 units of onabotulinum toxin A passed predetermined criteria for treatment efficacy and safety, and a randomized trial with either dose is warranted. The 100 unit dose may be preferable due to similar efficacy with reduced costs and adverse effects.
prostatic hyperplasia; onabotulinum toxin A
Hispanics are the fastest growing minority group in the United States. The incidence of end-stage renal disease (ESRD) in Hispanics is higher than non-Hispanic Whites and Hispanics with chronic kidney disease (CKD) are at increased risk for kidney failure. Likely contributing factors to this burden of disease include diabetes and metabolic syndrome, both are common among Hispanics. Access to health care, quality of care, and barriers due to language, health literacy and acculturation may also play a role. Despite the importance of this public health problem, only limited data exist about Hispanics with CKD. We review the epidemiology of CKD in US Hispanics, identify the factors that may be responsible for this growing health problem, and suggest gaps in our understanding which are suitable for future investigation.
Chronic Kidney Disease; Hispanics; Health Care Disparities
Identification of persons with chronic kidney disease (CKD) who are at highest risk to progress to end stage renal disease (ESRD) is necessary to reduce the burden of kidney failure. The relative utility of traditional markers of kidney function, including estimated glomerular filtration rate (GFR) and serum creatinine, and emerging markers of kidney function, including cystatin C and beta-trace protein (BTP), to predict ESRD and mortality has yet to be established.
Randomized clinical trial followed by an observational cohort study.
Setting & Participants
865 African American individuals with hypertensive CKD enrolled in a clinical trial of two levels of blood pressure control and three different antihypertensive drugs as initial therapy and subsequently followed by an observational cohort study.
Quintile of measured GFR (mGFR) by iothalamate clearance, serum creatinine, serum creatinine-based estimated GFR (eGFRSCr), cystatin C, and BTP.
Outcomes and Measurements
Incidence of ESRD and mortality.
A total of 246 participants reached ESRD over a median follow-up of 102 months. The incidence rate of ESRD was higher with higher quintiles of each marker. The association between higher BTP and ESRD was stronger than those for the other markers, including mGFR. All the markers remained significantly associated with ESRD after adjustment for mGFR and relevant covariates (all p<0.05), with BTP retaining the strongest association (HR for highest versus lowest quintile, 5.7; 95% CI, 2.2-14.9). Associations with the combined endpoint of ESRD or mortality (n=390) were weaker, but remained significant for cystatin C (p=0.05) and BTP (p=0.004).
The ability of these markers to predict ESRD and mortality in other racial and ethnic groups and among individuals with CKD due to other causes is unknown.
Plasma BTP and cystatin C may be useful adjuncts to serum creatinine and mGFR in evaluating risk for progression of kidney disease.
End-stage renal disease; beta trace protein; cystatin C; serum creatinine; iothalamate glomerular filtration rate
The timely recruitment of study participants is a critical component of successful trials. Benign prostatic hyperplasia (BPH), a common nonmalignant urologic condition among older men, is characterized by lower urinary tract symptoms (LUTS). Successful recruitment methods for a trial of medical therapy for BPH, Medical Therapy of Prostate Symptoms (MTOPS), were mass mailing and advertising. The Complementary and Alternative Medicines Trial for Urological Symptoms (CAMUS) was designed to evaluate a botanical therapy, saw palmetto, for the treatment of BPH. The objective of this study was to evaluate recruitment strategies for CAMUS and to contrast the baseline characteristics of CAMUS participants with those recruited to a similar trial using conventional medical therapy.
CAMUS is a randomized, double-blind, placebo-controlled trial designed to evaluate the effects of saw palmetto given at escalating doses over an 18-month period on relief from LUTS.
The target enrollment goal was 350 men with LUTS from 11 clinical centers over a 12-month period. The recruitment techniques used and participants contacted, screened, and randomized through each technique were obtained from the clinical centers. Baseline characteristics of the CAMUS participants were compared with participants in the MTOPS trial who met the CAMUS eligibility criteria for LUTS.
The target enrollment goal was achieved in 11 months. The overall monthly recruitment rate per site was 3.7 and ranged from 2.4 to 8.0. The most successful recruitment methods were mass mailing and advertising, which accounted for 39% and 35% of the study participants, respectively. In comparison to MTOPS participants, CAMUS participants were younger, more highly educated, more diverse, and had less severe urinary symptoms.
Successful recruitment methods for CAMUS were similar to those in MTOPS. The use of botanical therapy attracted a less symptomatic and more educated study population.
To identify clinical and demographic factors predictive of midurethral sling failure.
Overall treatment failure was defined by one or more of the following objective outcomes: a positive stress test, positive 24-hour pad test or re-treatment for stress urinary incontinence (SUI); subjective outcomes: self reported SUI by the Medical, Epidemiologic and Social Aspect of Aging questionnaire (MESA), incontinent episodes by 3-day diary, or retreatment for SUI, or a combination of these. Logistic regression models adjusting for sling type and clinical site were used to predict odds of overall treatment failure after univariable analysis. Models were also fit to compare factors associated with objective failure versus subjective failure only.
Prior UI surgery (odds ratio [OR] [95% CI], 1.99 [1.14, 3.47]); maximum Q-tip excursion < 30° (OR 1.89 (1.16, 3.05)); MESA urge score per 10 points (OR 1.97 [1.21, 3.21]); and pad weight per 10g (OR 1.06 [1.02, 1.10]) were predictors of overall failure. Having concomitant surgery (OR=0.44 [0.22,0.90]) was predictive of subjective failure only rather than objective failure. Age per 10 years (OR=1.48 [1.14, 1.90]); Urogenital Distress Inventory score per 10 points (OR=1.09[1.02–1.17]); pad weight per 10g (OR=1.05 [1.01, 1.10]) were predictive of objective failure compared to subjective failure only. Associations of risk factors and failure were similar independent of sling type (retropubic or transobturator).
Twelve months after surgery, risk factors for overall and objective treatment failure were similar in women undergoing retropubic and transobturator sling procedures. This information may assist in counseling patients regarding efficacy of sling procedures and in setting expectations for women at increased odds for treatment failure.
We investigate the association of different measures of adiposity (waist circumference, hip circumference, waist-to-hip ratio, body mass index (BMI)) with overactive bladder (OAB) (urinary frequency and urgency) and whether the association varies by gender or age and if it persists when models are adjusted for other confounders.
Materials and Methods
Data are from the Boston Area Community Health (BACH) epidemiologic survey, a random sample of 5503 Boston, MA residents aged 30 to 79 years with equal representation from three race/ethnic groups (Black, Hispanic, and White). Statistical analyses involved nonparametric loess models and multivariable logistic regression.
We show distinct patterns by gender for the association of various adiposity measures and OAB. Waist-to-hip ratio is not significantly associated with OAB in either gender. For women, the prevalence of OAB increases as waist (odds ratio (OR) adjusted for other confounders = 1.10 per 10 cm increase) or hip (OR=1.12 per 10 cm increase) circumference or BMI (OR=1.03 per kg/m2 increase) increases. For men, the prevalence of OAB decreases as adiposity increases (OR=0.65 per 10 cm increase in waist circumference, OR=0.71 per 10 cm increase in hip circumference, OR=0.87 per kg/m2 in BMI), but only to a certain point (waist circumference=100 cm, hip circumference=115 cm, BMI=27.5 kg/m2). At that point, the prevalence of OAB increases with increasing adiposity (OR=1.19 per 10 cm increase in waist circumference, OR=1.16 per 10 cm increase in hip circumference, OR=1.08 per kg/m2 in BMI).
The relationship between adiposity and OAB varies by gender.
overactive bladder; urinary frequency; urgency; urge leakage; obesity
This study was designed to examine the impact of elevated depressive affect on health outcomes among participants with hypertensive chronic kidney disease in the African-American Study of Kidney Disease and Hypertension (AASK) Cohort Study. Elevated depressive affect was defined by Beck Depression Inventory II (BDI-II) thresholds of 11 or more, above 14, and by 5-Unit increments in the score. Cox regression analyses were used to relate cardiovascular death/hospitalization, doubling of serum creatinine/end-stage renal disease, overall hospitalization, and all-cause death to depressive affect evaluated at baseline, the most recent annual visit (time-varying), or average from baseline to the most recent visit (cumulative). Among 628 participants at baseline, 42% had BDI-II scores of 11 or more and 26% had a score above 14. During a 5-year follow-up, the cumulative incidence of cardiovascular death/hospitalization was significantly greater for participants with baseline BDI-II scores of 11 or more compared with those with scores <11. The baseline, time-varying, and cumulative elevated depressive affect were each associated with a significant higher risk of cardiovascular death/hospitalization, especially with a time-varying BDI-II score over 14 (adjusted HR 1.63) but not with the other outcomes. Thus, elevated depressive affect is associated with unfavorable cardiovascular outcomes in African Americans with hypertensive chronic kidney disease.
AASK (African American Study of Kidney Disease and Hypertension); cardiovascular events; chronic kidney disease; depression
We estimate trends in the prevalence of urinary incontinence in the adult population of the United States from 2001 through 2008 before and after adjusting for other potential associated factors.
Materials and Methods
We analyzed data on 17,850 adults 20 years old or older who participated in the 2001 to 2008 cycles of the National Health and Nutrition Examination Survey. Any urinary incontinence was defined as a positive response to questions on urine leakage during physical activity, before reaching the toilet and during nonphysical activity. During this period changes in demographic and clinical factors associated with urinary incontinence included age, race/ethnicity, obesity, diabetes and chronic medical conditions (prostate disease in men). Age standardized prevalence estimates and prevalence ORs of urinary incontinence trends were determined using adjusted multivariate models with appropriate sampling weights.
The age standardized prevalence of urinary incontinence in the combined surveys was 51.1% in women and 13.9% in men. Prevalence in women increased from 49.5% in 2001 to 2002, to 53.4% in 2007 to 2008 (Ptrend = 0.01) and in men from 11.5% to 15.1%, respectively (Ptrend = 0.01). In women increased prevalence was partially explained by differences in age, race/ethnicity, obesity, diabetes and select chronic diseases across the survey periods. After adjustment the prevalence OR for 2007 to 2008 vs 2001 to 2002 decreased from 1.22 (95% CI 1.03–1.45) to 1.16 (95% CI 0.99–1.37). in men adjustment for potentially associated factors did not explain the increasing prevalence of urinary incontinence.
The age standardized prevalence of urinary incontinence increased in men and women from 2001 through 2008. Decreasing obesity and diabetes may lessen the burden of urinary incontinence, especially in women.
urinary incontinence; risk factors; epidemiology; female; male
Evidence suggests that the urogenital pain of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) may be neuropathic.
This randomized, double-blind, placebo-controlled trial was conducted across 10 tertiary care centers in North America to determine whether pregabalin, which has been proved effective in other chronic pain syndromes, is effective in reducing CP/CPPS symptoms. In 2006–2007, 324 men with pelvic pain for at least 3 of the previous 6 months were enrolled in this study. Men were randomly assigned to receive pregabalin or placebo in a 2:1 ratio and were treated for 6 weeks. Pregabalin dosage was increased from 150 to 600 mg/d during the first 4 weeks. The primary outcome was a 6-point decrease in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score. Multiple secondary outcomes were assessed.
Of 218 men assigned to receive pregabalin, 103 (47.2%) reported at least a 6-point decrease in the NIHCPSI total score at 6 weeks compared with 35.8% (38 of 106 men) assigned to receive placebo (P = .07, exact Mantel-Haenszel test, adjusting for clinical sites). Compared with the placebo group, men assigned to receive pregabalin experienced reductions in the NIH-CPSI total score and sub-scores (P < .05), a higher Global Response Assessment response rate (31.2% and 18.9%; P = .02), and improvement in total McGill Pain Questionnaire score (P = .01). Results for the other outcomes did not differ between groups.
Pregabalin therapy for 6 weeks was not superior to placebo use in the rate of a 6-point decrease (improvement) in the NIH-CPSI total score in men with CP/CPPS.
clinicaltrials.gov Identifier: NCT00371033
To describe the practice patterns among primary care physicians’ (PCPs’) managing patients with symptoms suggestive of interstitial cystitis/ painful bladder syndrome (IC/PBS).
We developed a clinical vignette describing a woman with typical IC/PBS symptoms to elicit questions about etiology, management strategies, and familiarity with this syndrome. We mailed the questionnaire to 556 PCPs, including academicians and community physicians, in Boston, Los Angeles and Chicago.
We received 290 completed questionnaires (response rate 52%). Nineteen percent of respondents reported they had ”never” seen a patient like the one described in the vignette. Two-thirds of respondents correctly identified the hallmark symptom of IC/PBS (bladder pain/pressure). Regarding etiology, 90% correctly indicated that IC/PBS was a non-infectious disease, 76% correctly reported that it was not caused by a sexually transmitted infection, and 61% correctly indicated that it was not caused by a psychiatric illness. Common treatments included antibiotics and nonsteroidal anti-inflammatory agents. Referrals were often made to a specialist.
Although most PCPs indicate familiarity with IC/PBS, they manage the condition infrequently. They also appear to have significant knowledge deficits about the clinical characteristics of IC/PBS, and they indicate variable practice patterns in the diagnosis and treatment of the condition. Educational efforts directed at PCPs will likely improve the care of patients with IC/PBS.
survey; knowledge; beliefs; pelvic pain
Introduction and Hypotheses
The objective of this study was to examine the effects of drug therapy alone and combined with behavioral therapy on urgency and 24-voiding frequency in women with urge-predominant incontinence and to identify predictors of change.
A planned analysis of data from a multi-site, randomized, controlled trial (N=307). Bladder diaries were used to document voids, incontinence, and urgency severity.
Urgency scores decreased significantly within both treatment groups, but changes did not differ between groups (p=0.30). Improvement in urgency was associated with greater baseline urgency (p<0.0001) and black ethnicity (p=0.03). Voiding frequency increased with drug alone and decreased slightly with combined therapy (p=0.009), and improvement was associated with combined treatment (p<0.0001), higher baseline frequency (p<0.0001), and lower baseline incontinence episode frequency (p=0.001).
Although combined drug and behavioral therapy does not appear to improve urgency more than drug alone, it resulted in better outcomes on voiding frequency.
Behavioral treatment; Drug therapy; Overactive bladder; Urge incontinence; Urinary frequency; Urinary urgency
In kidney transplant recipients, cardiovascular disease (CVD) is the leading cause of death. The relationship of kidney function with CVD outcomes in transplant recipients remains uncertain. We performed a post-hoc analysis of the Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT) Trial to assess risk factors for CVD and mortality in kidney transplant recipients. Following adjustment for demographic, clinical and transplant characteristics, and traditional CVD risk factors, proportional hazards models were used to explore the association of estimated GFR with incident CVD and all-cause mortality. In 4016 participants, mean age was 52 years and 20% had prior CVD. Mean eGFR was 49±18 mL/min/1.73m2. In 3,676 participants with complete data, there were 527 CVD events over a median of 3.8 years. Following adjustment, each 5 mL/min/1.73m2 higher eGFR at levels below 45 mL/min/1.73m2 was associated with a 15% lower risk of both CVD [HR = 0.85 (0.80, 0.90)] and death [HR = 0.85 (0.79, 0.90)], while there was no association between eGFR and outcomes at levels above 45 mL/min/1.73m2. In conclusion, in stable kidney transplant recipients, lower eGFR is independently associated with adverse events, suggesting that reduced kidney function itself rather than pre-existing comorbidity may lead to CVD.
Kidney Transplant; Glomerular Filtration Rate; Cardiovascular Disease; Chronic Kidney Disease; Epidemiology; Mortality
Depression is common in end-stage renal disease and is associated with poor quality of life and higher mortality; however, little is known about depressive affect in earlier stages of chronic kidney disease. To measure this in a risk group burdened with hypertension and kidney disease, we conducted a cross-sectional analysis of individuals at enrollment in the African American Study of Kidney Disease and Hypertension Cohort Study. Depressive affect was assessed by the Beck Depression Inventory II and quality of life by the Medical Outcomes Study-Short Form and the Satisfaction with Life Scale. Beck Depression scores over 14 were deemed consistent with an increased depressive affect and linear regression analysis was used to identify factors associated with these scores. Among 628 subjects, 166 had scores over 14 but only 34 were prescribed antidepressants. The mean Beck Depression score of 11.0 varied with the estimated glomerular filtration rate (eGFR) from 10.7 (eGFR 50–60) to 16.0 (eGFR stage 5); however, there was no significant independent association between these. Unemployment, low income, and lower quality and satisfaction with life scale scores were independently and significantly associated with a higher Beck Depression score. Thus, our study shows that an increased depressive affect is highly prevalent in African Americans with chronic kidney disease, is infrequently treated with antidepressants, and is associated with poorer quality of life. Sociodemographic factors have especially strong associations with this increased depressive affect. Because this study was conducted in an African-American cohort, its findings may not be generalized to other ethnic groups.
AASK (African American Study of Kidney Disease and Hypertension); chronic kidney disease; clinical epidemiology; depression; quality of life
Benign prostatic hyperplasia (BPH), a common condition among older men, confers its morbidity through potentially bothersome lower urinary tract symptoms. Treatments for BPH include drugs such as alpha adrenergic receptor blockers and 5-alpha reductase inhibitors, minimally invasive therapies that use heat to damage or destroy prostate tissue, and surgery including transurethral resection of the prostate. Complementary and alternative medicines are gaining popularity in the U.S. Two phytotherapies commonly used for BPH are extracts of the fruit of Serenoa repens, the Saw palmetto dwarf palm that grows in the Southeastern U.S., and extracts of the bark of Pygeum africanum, the African plum tree.
The objective of the Complementary and Alternative Medicines for Urological Symptoms (CAMUS) clinical trial is to determine if phytotherapy is superior to placebo in the treatment of BPH.
CAMUS was originally designed as a 3300-participant, four-arm trial of Serenoa repens, Pygeum africanum, an alpha adrenergic blocking drug, and placebo with time to clinical progression of BPH, a measure of long-term efficacy, as the primary endpoint. Before enrollment started, a randomized, double-blind, placebo-controlled, single institution clinical trial showed that Serenoa repens at the usual dose did not demonstrate any benefit over placebo with respect to symptom relief at one year. Consequently, the focus of CAMUS shifted from evaluating long-term efficacy to determining if any short-term (6-18 month) symptom relief could be achieved with increasing doses of Serenoa repens, the phytotherapy most commonly used in the U.S. for BPH.
Results are anticipated in 2011.
Trial design occurs in an environment of continually evolving information. In this case, emerging results from another trial suggested that a study of long-term efficacy was premature, and that an effective dose and preparation of Serenoa repens had to be established before proceeding to a long-term clinical trial.
botanical therapy; benign prostatic hyperplasia; clinical trial; trial re-design
To examine the relationship between magnitude of weight loss and changes in urinary incontinence frequency.
Overweight and obese women (N=338) with 10 or more urinary incontinence episodes per week were assigned randomly to an intensive 6-month behavioral weight loss program followed immediately by a 12-month weight maintenance program (intervention; n=226) or to a structured education program (control; n=112). The intervention and control groups were combined to examine the effects of the magnitude of weight loss on changes in urinary incontinence assessed by 7-day voiding diary, pad test, and self-reported satisfaction with change in urinary incontinence.
Compared with participants who gained weight (reference), those who lost 5% to less than 10% or 10% or more of their body weight had significantly greater percent reductions in urinary incontinence episodes and were more likely to achieve at least a 70% reduction in the frequency of total and urge urinary incontinence episodes at 6, 12, and 18 months. Satisfaction was also related to magnitude of weight loss; approximately 75% of women who lost 5% to less than 10% of their body weight reported being moderately or very satisfied with their changes in urine leakage.
Weight losses between 5% and 10% of body weight were sufficient for significant urinary incontinence benefits. Thus, weight loss should be considered as initial treatment for incontinence in overweight and obese women.
Initial weight loss improves urinary incontinence in overweight and obese women. In this study we examined the longer term effects of a weight loss intervention on urinary incontinence.
Materials and Methods
Overweight and obese women (mean ± SD age 53 ± 10 years) with 10 or more urinary incontinence episodes weekly were randomized to an 18-month behavioral weight loss intervention (226) or control group (112). Outcome measures were collected at 12 and 18 months.
At baseline women had a mean body mass index of 36 ± 6 kg/m2 and reported a mean of 24 ± 18 incontinence episodes weekly. Of the patients 86% completed 18-month measurements. The percent weight loss in the intervention group averaged 8.0%, 7.5% and 5.5% at 6, 12 and 18 months, respectively, vs approximately 1.5% in the control group (all values p < 0.001). Compared with controls at 12 months the intervention group reported a greater percent reduction in weekly stress urinary incontinence episodes (65% vs 47%, p < 0.001), and a greater proportion achieved at least a 70% decrease in weekly total and stress urinary incontinence episodes. At 18 months a greater proportion of women in the weight loss intervention group had more than 70% improvement in urge incontinence episodes but there were no significant differences between the groups for stress or total urinary incontinence. The intervention group also reported greater satisfaction with changes in urinary incontinence than the control group at 6, 12 and 18 months.
Weight loss intervention reduced the frequency of stress incontinence episodes through 12 months and improved patient satisfaction with changes in incontinence through 18 months. Improving weight loss maintenance may provide longer term benefits for urinary incontinence.
urinary incontinence; obesity; weight loss; behavior therapy; randomized controlled trial
To investigate cognitive impairment in older, ethnically diverse individuals with a broad range of kidney function, to evaluate a spectrum of cognitive domains and to determine whether the relationship between CKD and cognitive function is independent of demographic and clinical factors.
Chronic Renal Insufficiency Cohort Study.
825 adults ≥55 years with CKD.
We estimated glomerular filtration rate (eGFR, ml/min/1.73 m2) using the four-variable Modification of Diet in Renal Disease equation. We compared cognitive scores on six cognitive tests across eGFR strata using linear regression; multivariable logistic regression was used to examine level of CKD and clinically significant cognitive impairment (score ≤1 sd from mean).
Mean age of the participants was 64.9 years, 50% were male and 45% were Black. After multi-variable adjustment, participants with lower eGFR had lower cognitive scores on most cognitive domains (P<0.05). In addition, compared with persons who had mild or moderate CKD (eGFR 45-59), participants with advanced CKD (eGFR <30) were more likely to have clinically significant cognitive impairment on global cognition (adjusted odds ratio [OR] 2.0, 95% CI 1.1-3.9), naming (OR 1.9, 95% CI 1.0-3.3), attention (OR 2.4, 95%CI 1.3-4.5), executive function (OR 2.5, 95%CI 1.9- 4.4) and delayed memory, (OR=1.5, 95%CI 0.9-2.6) but not on category fluency (OR=1.1, 95% CI 0.6-2.0).
Among older adults with CKD, lower level of kidney function was associated with lower cognitive function on most domains. Our results suggest that older patients with advanced CKD should be screened for cognitive impairment.
Chronic kidney disease; cognitive impairment; cognitive function
The effect of urine leakage on quality of life (QOL) is related to severity of leakage. This study investigates gender and race/ethnic differences in this relationship.
An epidemiologic survey was conducted with a population-based random sample of 3,202 women and 2,301 men (1,767 Black, 1,877 Hispanic, 1,859 White) aged 30–79 years in Boston MA. Severity of leakage was based on frequency and amount by the Sandvik Severity Scale. QOL was measured with physical (PCS) and mental (MCS) component summaries of Medical Outcomes Study Short-Form-12 (SF-12). Covariates included race/ethnicity, age, socioeconomic status, urinary incontinence risk factors, and comorbidities. Analysis included multivariate linear regression modeling by gender.
30% of women and 18% of men reported urine leakage, most was mild or moderate. Women (5.1%) were more likely than men (0.9%) to report severe leakage. In multivariate analysis, as severity of leakage increased, both components of QOL declined, with decreases in scores of 7–8 points for men (p≤0.001 for each) and 4–6 points (p<0.05 and p=0.001 respectively) for women. Severe leakage was associated with a greater decline in QOL than was observed for most other co-morbidities considered. The impact of urine leakage on QOL was similar among racial and ethnic groups.
Urine leakage impairs QOL for both men and women, with no evidence of different effects by racial/ethnic group. Leakage has clinically significant impacts on physical health related QOL for men and on mental health QOL for both men and women.
Urinary incontinence; quality of life
To date, separate condition-specific instruments have been used to assess symptom severity in men and women with urologic pain conditions. A single instrument for use in both men and women would be helpful for assessing treatment response in clinical trials and cohort studies involving both genders.
We developed the Genitourinary Pain Index (GUPI) by modifying and adding questions to the NIH Chronic Prostatitis Symptom Index. To assess discriminant validity, concurrent validity, and reliability, we administered the GUPI to 1,653 men and 1,403 women in a large managed care population. To assess responsiveness, we administered the GUPI to 47 men and women who completed an NIH-sponsored trial of pelvic floor physical therapy.
The GUPI discriminated between men with chronic prostatitis or interstitial cystitis, men with other symptomatic conditions (dysuria, frequency, chronic cystitis), and men with none of these diagnoses (p<0.05). It also discriminated between women with interstitial cystitis, women with incontinence, and women with none of these diagnoses (p<0.05). The GUPI demonstrated good internal consistency within subscale domains, and GUPI scores correlated highly with scores on the Interstitial Cystitis Symptom Index and Problem Index. The GUPI was highly responsive to change, and thechange in score was similar in both male and female responders. A reduction of 7 points robustly predicted being a treatment responder (sensitivity 100%, specificity 76%).
The GUPI is a valid, reliable and responsive instrument that can be used to assess the degree of symptoms in both men and women with genitourinary pain complaints.
interstitial cystitis; chronic prostatitis; questionnaire; psychometrics