We compared reports of symptom bother for the same urinary symptoms to understand why symptom severity and bother do not correspond in a straightforward manner. We used a grounded theory approach to analyze qualitative data from 123 individual interviews and developed a conceptual framework, identifying three symptom perceptions that might “moderate” symptom bother: causal, relative, and uncertainty. Symptom bother was lower for respondents who viewed symptoms causally (symptoms seemed explainable or “normal”) or relatively (urinary symptoms were compared to other symptoms or conditions). Bother tended to be higher for respondents who viewed symptoms with uncertainty (when symptom etiology and course were unknown). A greater portion of respondents in the causal perception group had not sought health care for their symptoms. This conceptual framework is useful for understanding the relationship between reactions to and health care-seeking for other symptoms.
community and public health; health seeking; interviews; semistructured; qualitative analysis; sensitive topics
Determine whether urodynamic measures of urethral function [(valsalva leak point pressure (VLPP); maximal urethral closure pressure (MUCP); functional urethral length (FUL)] and the results of the supine empty bladder stress test (SEBST) correlate with each other and with subjective and objective measures of urinary incontinence (UI).
Data were collected preoperatively from subjects enrolled in a multicenter surgical trial of midurethral slings. Subjective measures included questionnaire scores from the Medical Epidemiological and Social Aspects of Aging questionnaire, Urogenital Distress Inventory, and Incontinence Impact Questionnaire. Objective measures included a 24-hour pad weight test, incontinence episode frequency on a 3-day voiding diary, and a SEBST.
597 women enrolled. 372 women had valid VLPP values; 539 had valid MUCP/FUL values. Subjective measures of severity had weak to moderate correlation with each other and with objective measures of severity. VLPP and MUCP had moderate correlation with each other (r =0.36, p<0.001). Urodynamic measures of urethral function had little or no correlation with subjective or objective measures of severity. Subjects with a positive SEBST had more severe subjective and objective severity measures compared to the negative SEBST group, but they did not have significantly different VLPP and MUCP values.
VLPP and MUCP have moderate correlation with each other, but each had little or no correlation with subjective or objective measures of severity or with the results of the SEBST. This data suggests that the urodynamic measures of urethral function are not related to subjective or objective measures of UI severity.
Correlation; empty bladder stress test; Maximum Urethral Closure Pressure (MUCP); severity; stress urinary incontinence; Valsalva Leak Point Pressure (VLPP)
To compare the descriptive epidemiology of overactive bladder (OAB) of presumed neurologic origin (NOAB) to OAB of non-neurologic origin (N-NOAB).
5,503 community-dwelling persons aged 30-79 were interviewed regarding urologic symptoms (2002-2005). NOAB was defined as symptoms of urgency and/or urgency incontinence among those with a self-reported history of health care provider diagnosed stroke (N=98), multiple sclerosis (N=21), or Parkinson’s disease (N=7). N-NOAB was defined identically but occurring among those not reporting neurologic disease (ND). Prevalence estimates were weighted to reflect sampling design; chi-square, Fisher’s exact, or t-tests were used to test differences. Urologic symptom interference was assessed using the Epstein scale, while the impact of urinary incontinence (UI) on health-related quality-of-life (HRQOL) was measured using a modification of the Incontinence Impact Questionnaire-7.
45 (31.0%) of 125 persons with ND and 994 (16.7%) of 5378 persons without ND reported OAB symptoms. The overall prevalence of NOAB and N-NOAB was 0.6% and 16.4%, respectively. Persons with NOAB had higher (worse) mean American Urologic Association Symptom Index scores (13.0 vs. 10.0, p=0.09) compared to those with N-NOAB, and were significantly more likely to have diabetes, high blood pressure, cardiac disease and fair/poor self-reported health (all p<0.05). Mean symptom interference and UI HRQOL scores were significantly higher (worse) in the NOAB group compared to persons with N-NOAB (all p<0.05).
Persons with NOAB appeared to have a greater burden of urologic illness with respect to symptom interference and HRQOL compared to persons with N-NOAB.
neurogenic bladder; epidemiology; overactive bladder
To identify predictors and correlates of patient satisfaction 24 months after Burch colpopexy or autologous fascial sling for treatment of stress urinary incontinence (SUI).
Participants were the 655 randomized subjects in the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr). Variables potentially associated with satisfaction were tested in bivariate analysis, including demographics, baseline clinical characteristics of incontinence, and outcomes on validated subjective and objective measures. Satisfaction with treatment was defined as a response of “completely satisfied” or “mostly satisfied” on the Patient Satisfaction Questionnaire (PSQ) at 24 months. Variables significantly related to satisfaction were entered into multivariable regression models to test their independent association with satisfaction.
At 24 months post-surgery, 480 (73%) participants completed the PSQ. Mean (±SD) age of the sample was 52 (±10) years and 77% were white. Most (82%) were completely or mostly satisfied with their surgery related to urine leakage. In the final multivariable model, patient satisfaction was associated with greater reduction in SUI symptoms (from baseline to 24 months; OR=1.17, 95% CI:1.10, 1.24) and greater reductions in symptom distress (OR=1.16; CI:1.08, 1.24). Lower odds of satisfaction were associated with greater urge incontinence symptoms at baseline (OR=0.09, CI:0.04, 0.22), detrusor overactivity at 24 months (OR=0.29, CI:0.12, 0.69), and a positive stress test at 24 months (OR=0.45, CI:0.22, 0.91).
Stress incontinent women who also have urge incontinence symptoms may benefit from additional preoperative counseling to set realistic expectations about potential surgical outcomes or proactive treatment of urge incontinence symptoms to minimize their post-operative impact.
patient outcomes assessment; patient satisfaction; surgery; urinary incontinence
Systematic cognitive training produces long-term improvement in cognitive function and less difficulty in performing activities of daily living. We examined whether cognitive training was associated with reduced rate of incident dementia. Participants were from the Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) study (n=2,802). Incident dementia was defined using a combination of interview- and performance-based methods. Survival analysis was used to determine if ACTIVE treatment affected the rate of incident dementia during 5 years of follow-up. A total of 189 participants met criteria for incident dementia. Baseline factors predictive of incident dementia were older age, male gender, African American race, fewer years of education, relationship other than married, no alcohol use, worse MMSE< worse SF-36 physical functioning, higher depressive symptomatology, diabetes, and stroke (all p<.05). A multivariable model with significant predictors of incident dementia and training group revealed that cognitive training was not associated with a lower rate of incident dementia. Cognitive training did not affect rates of incident dementia after 5 years of follow-up. Longer follow-up or enhanced training may be needed to fully explore the preventive capacity of cognitive training in forestalling onset of dementia.
Cognitive training; Intervention; Aging; Dementia; Prevention; Cognition
Patient-reported outcomes are a valuable tool for assessing healthcare, particularly for symptom-based conditions that lack definitive physiological measures of treatment efficacy.
To explore the value of qualitative methods for understanding and developing patient-reported outcomes of medical care for symptom-based conditions by examining the case of lower urinary tract symptoms.
Semi-structured interviews were conducted with a diverse, community sample of 90 respondents who had spoken with a provider about their urinary symptoms. Content and thematic analyses were conducted for the areas of symptom relief, patient adherence, and satisfaction with care according to gender, race or ethnicity, and socioeconomic status.
Across social groups, most patients experienced either no symptom relief or partial relief, reported that they adhered to recommendations, and were satisfied with the care received. The primary reason for no symptom relief was not receiving a treatment recommendation. For patients, even partial relief made symptoms more manageable both physically and emotionally. Satisfaction with care was mediated by the quality of the patient-provider relationship as well as expectations other than symptom relief, particularly for patients of low socioeconomic status.
Patients’ assessments of the outcomes of seeking medical care for this symptom-based condition broadened the criteria for quality of care beyond providing a cure. For health care providers, this can widen the path for meeting patient needs, even without complete symptom relief. For providers and researchers, as the evidence base expands to include patient reports, the context provided by a qualitative approach can enhance understanding of patients’ perspectives and the ability to construct meaningful quantitative measures.
patient outcomes assessment; qualitative research; urinary tract symptoms
To examine the association between use of medications and prevalence of urinary incontinence (UI) in gender-specific analyses of a community-based, representative sample.
Materials and Methods
A population-based epidemiologic study was conducted among 5,503 men and women aged 30-79 residing in Boston, Massachusetts (baseline data collected 2002-2005). Urologic symptoms were ascertained in a two-hour, in-person interview. UI was defined as urine leakage occurring weekly or more often, considering the past year. Medications used in the past month were considered ‘current use’. Associations of 20+ medications and prevalent UI were examined using multivariable logistic regression (odds ratios [ORs] and 95% confidence intervals [CIs]) with adjustments for known UI risk factors.
UI prevalence in the analysis sample was 9.0% in women and 4.6% in men. Among women, prevalence was highest among users of certain antihistamines (28.4%) and angiotensin II receptor blockers (ARBs) (22.9%). Among men, prevalence was highest among ARB (22.2%) and loop diuretic (19.1%) users. After final multivariable adjustment, there were significant positive associations for certain antihistamines, beta receptor agonists, ARBs, and estrogens with UI among women (all ORs >1.7), and a borderline-significant association for anticonvulsants (OR=1.75, 95% CI: 1.00, 3.07). Among men, only anticonvulsants (OR=2.50, 95% CI: 1.24, 5.03) were associated with UI after final adjustments, although ARBs showed an adjusted association of borderline significance (OR=2.21, 95% CI: 0.96, 5.10).
Although a cross-sectional analysis cannot determine causality, our analysis suggests certain medications should be further examined in longitudinal analyses of risk to determine their influence on urologic symptoms.
medications; urinary incontinence; pharmacoepidemiology; epidemiology
We investigated the influence of social ties on symptom management and help seeking, using urinary symptoms as a case study. Talking with others about these symptoms was common and both facilitated and hindered symptom management and help seeking. In some cases, talking with others resulted in gaining a sense of identification with others suffering the same symptoms, receiving assistance to ease the burden of symptoms, obtaining suggestions to help manage symptoms, and learning information about available treatments. In other cases, talking with others served to normalize symptoms to such an extent that individuals saw no need to manage their symptoms differently.
communication; interviews; health seeking; relationships; symptom management
Study participants reported a range of remedies used to treat urinary symptoms, from popular products like saw palmetto to less commonly known remedies such as moabi. Many learned about remedies through social networks rather than from their primary care provider.
Complementary and Alternative Therapies; Urinary Symptoms; Social Relationships and Health
A gap between experiencing symptoms and receiving effective treatment persists for people with lower urinary tract symptoms (LUTS), even for those who seek health care. In order to better understand how patients experience treatment seeking for LUTS, we interviewed a racially diverse sample of 90 men and women with a range of LUTS about their experiences seeking care. Thematic analysis revealed that patients often disclosed urinary symptoms first to primary care providers during a general examination or a visit for another health problem. Patients seek provider assistance typically when symptoms have intensified or are causing worry, and a desire for treatment trumps potential embarrassment; among women patients, feeling comfortable with a provider also is important for disclosing LUTS.
Help seeking; urinary symptoms; primary care; provider/patient communication; qualitative research
Urodynamic studies are commonly performed in women before surgery for stress urinary incontinence, but there is no good evidence that they improve outcomes.
We performed a multicenter, randomized, noninferiority trial involving women with uncomplicated, demonstrable stress urinary incontinence to compare outcomes after preoperative office evaluation and urodynamic tests or evaluation only. The primary outcome was treatment success at 12 months, defined as a reduction in the score on the Urogenital Distress Inventory of 70% or more and a response of “much better” or “very much better” on the Patient Global Impression of Improvement. The predetermined noninferiority margin was 11 percentage points.
A total of 630 women were randomly assigned to undergo office evaluation with urodynamic tests or evaluation only (315 per group); the proportion in whom treatment was successful was 76.9% in the urodynamic-testing group versus 77.2% in the evaluation-only group (difference, −0.3 percentage points; 95% confidence interval, −7.5 to 6.9), which was consistent with noninferiority. There were no significant between-group differences in secondary measures of incontinence severity, quality of life, patient satisfaction, rates of positive provocative stress tests, voiding dysfunction, or adverse events. Women who underwent urodynamic tests were significantly less likely to receive a diagnosis of overactive bladder and more likely to receive a diagnosis of voiding-phase dysfunction, but these changes did not lead to significant between-group differences in treatment selection or outcomes.
For women with uncomplicated, demonstrable stress urinary incontinence, preoperative office evaluation alone was not inferior to evaluation with urodynamic testing for outcomes at 1 year. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT00803959.)
Testosterone supplementation has been shown to increase muscle mass and strength in healthy older men. The safety and efficacy of testosterone treatment in older men who have limitations in mobility have not been studied.
Community-dwelling men, 65 years of age or older, with limitations in mobility and a total serum testosterone level of 100 to 350 ng per deciliter (3.5 to 12.1 nmol per liter) or a free serum testosterone level of less than 50 pg per milliliter (173 pmol per liter) were randomly assigned to receive placebo gel or testosterone gel, to be applied daily for 6 months. Adverse events were categorized with the use of the Medical Dictionary for Regulatory Activities classification. The data and safety monitoring board recommended that the trial be discontinued early because there was a significantly higher rate of adverse cardiovascular events in the testosterone group than in the placebo group.
A total of 209 men (mean age, 74 years) were enrolled at the time the trial was terminated. At baseline, there was a high prevalence of hypertension, diabetes, hyperlipidemia, and obesity among the participants. During the course of the study, the testosterone group had higher rates of cardiac, respiratory, and dermatologic events than did the placebo group. A total of 23 subjects in the testosterone group, as compared with 5 in the placebo group, had cardiovascular-related adverse events. The relative risk of a cardiovascular-related adverse event remained constant throughout the 6-month treatment period. As compared with the placebo group, the testosterone group had significantly greater improvements in leg-press and chest-press strength and in stair climbing while carrying a load.
In this population of older men with limitations in mobility and a high prevalence of chronic disease, the application of a testosterone gel was associated with an increased risk of cardiovascular adverse events. The small size of the trial and the unique population prevent broader inferences from being made about the safety of testosterone therapy.
Introduction and hypothesis
We hypothesized that certain preoperative voiding symptoms would be correlated with poorer post-continence surgery outcomes in women.
Preoperative voiding symptoms from 655 women were assessed with questionnaires. Outcomes (overall failures, stress-specific failures, and voiding dysfunction) after Burch or sling surgery were measured. Logistic regression models were used to associate preoperative voiding symptoms with postoperative outcomes.
Hesitating urinary stream was associated with voiding dysfunction [OR 2.22, p=0.01], overall [OR 1.57, p=0.03], and stress-specific [OR 1.67, p=0.009] failures. A ten-point increase in preoperative Urogenital Distress Inventory-obstructive (UDI-O) subscore was associated with overall [OR 1.10, p=0.049] and stress-specific [OR 1.21, p<0.0001] failures. Even controlling for severity of POPQ stage, significant associations of hesitating urinary stream with voiding dysfunction, overall and stress-specific failures remained.
Preoperative hesitating urinary stream and obstructive voiding symptoms were associated with poorer surgical outcomes. Further studies in this area may be fruitful.
Surgical outcome; Stress urinary incontinence; Voiding dysfunction; Voiding symptoms
Health beliefs are an important mediator between the experience of symptoms and health behaviors, and these beliefs can vary by race or ethnicity.
To better understand the gap between experiencing symptoms and not seeking medical care by studying health beliefs about lower urinary tract symptoms (LUTS) across race and ethnic groups.
Qualitative, semistructured interviews were conducted with 35 Black, Hispanic, and White people who reported at least one urinary symptom but had not spoken with a health care provider about the symptoms. Drawing on Shaw’s framework of health behavior and outcomes, a range of beliefs was examined: cause, consequence, continuation, and treatability. Interviews were transcribed, coded, and analyzed for themes according to race or ethnic background.
The belief that LUTS are a typical part of aging and not amenable to medical treatment was most common among White respondents. Black respondents more commonly attributed their symptoms to personal behaviors over which they had control and therefore did not require medical care. Hispanic respondents appeared more often to live with uncertainty about the cause of their symptoms and an accompanying concern about a future health consequence.
The combination of a range of health beliefs to form a cognitive representation made sense of the behavior of not seeking medical care. The finding that sociocultural differences shaped these cognitive representations underscores the need for cultural competency in patient assessment and education. Results have implications for theories of health behavior and indicate further research with larger samples, additional psychosocial influences, and other symptoms.
cognitive aspects; cultural competency; health behavior; urinary tract
The association between depression and functional disability in late life remains unclear. This study aimed to explore the relationship between depressive symptoms and daily functioning through the mediation of cognitive abilities, measured by memory, reasoning, and speed of processing.
We recruited 2,832 older adults (mean age = 73.6 years, SD = 5.9) participating in the Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) Study. Structural equation modeling (SEM) was applied to illustrate the relationship between depressive symptoms and everyday problem-solving ability through the mediation of cognitive abilities.
Depressive symptoms were associated with impaired everyday problem-solving ability directly and indirectly mediated via learning and memory, and reasoning. Although depressive symptoms were associated with speed of processing, speed of processing was not significantly related to everyday problem-solving ability.
This study conceptualizes the possible relationships between depressive symptoms and daily functioning with mediation of cognitive abilities and provides a feasible model for the prevention of functional impairment related to geriatric depressive symptoms.
depression; cognition; everyday function; elderly
Aims and objective
To determine, qualitatively and quantitatively, how individuals use fluid manipulation to self-manage the urinary symptoms of daytime frequency, urgency and urine leakage and the underlying rationale for this behaviour.
Lower urinary tract symptoms are prevalent and burdensome, and little is known about how individuals with lower urinary tract symptoms manipulate their fluid intake.
A mixed methods design included statistical analysis of data from a population-based survey of urologic symptoms and qualitative analysis of in-depth interviews.
Quantitative data came from 5503 participants of the baseline Boston Area Community Health Survey, a population-based, random sample epidemiologic survey of urologic symptoms. Qualitative data came from in-depth interviews with a random subsample from Boston Area Community Health of 152 black, white and Hispanic men and women with LUTS.
Qualitative data showed that some respondents restricted fluid intake while others increased it, in both cases with the expectation of improved symptoms. Quantitative data showed that fluid intake was greater in men and women reporting frequency (p < 0·001). Women with frequency drank significantly more water (p < 0·001), while women with urgency drank significantly less water (p = 0·047).
This study found divergent expectations of the role of fluids in alleviating symptoms, leading some individuals to restrict and others to increase fluid intake. Individuals with lower urinary tract symptoms may need guidance in fluid management.
Relevance to clinical practice
Nurses should be aware that patients may self-manage lower urinary tract symptoms by restricting fluid intake, putting them at risk for dehydration, constipation and urinary tract infection, but also that they may be increasing their fluid intake, which could worsen symptoms. This study pinpoints a specific area of need among patients with lower urinary tract symptoms and provides a practical opportunity for nurses to assist their patients with behavioural and fluid management by emphasising the clinical guidelines.
behaviour; care needs; coping; lower urinary tract symptoms; mixed methods; qualitative approaches; self-management
This paper is a report of a study conducted to characterize the stigma of urinary frequency and urgency and differentiate it from the stigma of incontinence and to describe race/ethnic and gender differences in the experience of stigma among a diverse sample of individuals.
Lower urinary tract symptoms, including frequency, urgency and incontinence, are susceptible to stigma, but previous stigma research has focused almost exclusively on incontinence.
The Boston Area Community Health Survey is a population-based, random sample epidemiological survey of urologic symptoms (N=5503). Qualitative data for this study came from in-depth interviews conducted between 2007 and 2008 with a random subsample of 151 black, white and Hispanic men and women with urinary symptoms.
Respondents reported stigma associated with frequency and urgency – not just incontinence. The stigma of frequency/urgency is rooted in social interruption, loss of control of the body, and speculation as to the nature of a non-specific “problem.” Overall, the stigma of urinary symptoms hinged upon whether or not the problem was “perceptible.” Men felt stigmatized for making frequent trips to the bathroom and feared being seen as impotent. Women feared having an unclean body or compromised social identity. Hispanic people in particular voiced a desire to keep their urinary symptoms a secret.
The stigma of urinary symptoms goes beyond incontinence to include behaviors associated with frequency and urgency. Healthcare practitioners should assess for stigma sequelae (e.g. anxiety, depression) in individuals with frequency and urgency, and stress treatment options to circumvent stigmatization.
Nursing; healthcare professionals; stigma; public health; urinary incontinence; urinary symptoms
Women with urge urinary incontinence are commonly treated with antimuscarinic medications, but many discontinue therapy.
To determine whether combining antimuscarinic drug therapy with supervised behavioral training, compared to drug therapy alone, improves the ability of women with urge incontinence to achieve clinically important reductions in incontinence episodes and to and sustain these improvements after discontinuing medication.
Two-stage, multi-center, randomized clinical trial (BE-DRI trial) (July 2004 – January 2006).
Nine university-affiliated outpatient clinics.
307 women with urge predominant incontinence.
Ten weeks of open-label, extended-release tolterodine alone (N = 153) or combined with behavioral training (N = 154) (Stage 1), followed by discontinuation of therapy and follow-up at 8 months (Stage 2); 237 participants completed the trial.
The primary outcome, measured at 8 months, was defined as not taking drug or receiving any other therapy for urge incontinence and ≥70% reduction in frequency of incontinence episodes. Secondary outcomes were reduction in incontinence, self-reported satisfaction and improvement, and scores on validated questionnaires measuring symptom distress/bother and health-related quality-of-life. Study staff who performed outcome evaluations were blinded to group assignment, but participants and interventionists were not.
At 8 months, there was no difference in successful discontinuation of drug therapy between combined therapy and drug alone (41% in both groups, 95% confidence interval on difference: -12% to +12%). A higher proportion of patients in combined therapy achieved ≥70% reduction of incontinence than in drug therapy alone at 10 weeks (69% vs. 58%; difference = 11%; 95% confidence interval: -0.3 to +22.1). Combined therapy yielded better outcomes over time on the Urogenital Distress Inventory and Overactive Bladder Questionnaire (both P<0.001), at both time points on patient satisfaction and perceived improvement, but not health-related quality-of-life. Adverse events were uncommon in both groups (12 events in 6 participants, 3 in each group).
Inclusion of behavioral components (daily bladder diary and recommendations for fluid management) in the drug alone group may have attenuated group differences. Assigned treatment was completed by 68% of participants and 8 month outcome status was assessed on 77%.
The addition of behavioral training to drug therapy is of possible benefit for reducing incontinence frequency during active treatment, but does not improve women's ability to discontinue drug therapy and maintain improvement in urinary incontinence. Further, combined therapy has a beneficial effect on patient satisfaction, perceived improvement, and reducing other bladder symptoms.
urinary urge incontinence; drug therapy; behavioral therapy; combined modality therapy; quality of life; pelvic floor muscle exercises
To determine whether urological symptom clusters, as identified in previous studies, were associated with health-related quality-of-life (HRQoL) and use of healthcare.
SUBJECTS AND METHODS
The Boston Area Community Health Survey is a population-based epidemiological study of 2301 male and 3201 female residents of Boston, MA, USA, aged 30–79 years. Baseline data collected from 2002 to 2005 were used in this analysis. Data on 14 urological symptoms were used for the cluster analysis, and five derived symptom clusters among men and four among women were used in multivariate linear regression models (adjusted for age group, race/ethnicity, and comorbidity) to determine their association with physical (PCS-12) and mental health component scores (MCS-12) calculated from the Medical Outcomes Study 12-item Short Form Survey.
For both men and women, being in the most symptomatic cluster was associated with decrements in the PCS-12 score (men, cluster 5, −10.42; women, cluster 4, −9.80; both P < 0.001) and the MCS-12 score (men, cluster 5, −9.35; women, cluster 4, −6.24; both P < 0.001) compared with the asymptomatic groups. Both men and women in these most symptomatic clusters appeared to have adequate access to healthcare.
For men and women, those with the most urological symptoms reported poorer HRQoL in two domains after adjusting for age and comorbidity, and despite adequate access to care.
lower urinary tract symptoms; cluster analysis; urological symptoms; epidemiology
We evaluated the effect of cognitive training among 1,534 participants in the Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) randomized controlled trial (RCT) on 5-year improvements in 3 cognitive-specific measures of locus of control—internal, chance, and powerful others.
ACTIVE was a multisite RCT (age ≥ 65), with 4 groups (memory, reasoning, speed of processing, and no-contact control). Complete 5-year follow-up data were available for 1,534 (55%) of the 2,802 participants. A propensity score model was used to adjust for potential attrition bias. Clinically important improvements (and decrements) in the cognitive-specific locus of control scale scores were defined as greater than or equal to 0.5 SD (medium) and greater than or equal to 1.0 SD (large). Multinomial logistic regression was used to simultaneously contrast those who improved and those who declined with those whose locus of control scale score was unchanged.
Statistically significant effects reflecting medium-sized (≥0.5 SD) improvements in internal locus of control between baseline and the 5-year follow-up were found for the reasoning and speed of processing intervention groups who were 76% (p < .01) and 68% (p < .05) more likely, respectively, to improve than the no-contact control group. No improvement effects were found on the chance or powerful others locus of control measures or for the memory intervention group.
Cognitive training that targets reasoning and speed of processing can improve the cognitive-specific sense of personal control over one’s life in older adults.
cognitive status; personal control; randomized controlled trial; speed of processing
We evaluated the effects of cognitive training on self-rated health at 1, 2, 3, and 5 years post-baseline.
ACTIVE randomly assigned 2,802 older adults (age ≥ 65) to memory, reasoning, speed of processing, or no-contact control intervention groups. Complete data were available for 1,804 (64%) of the 2,802 participants at 5-years. A propensity score model adjusted for attrition bias. The self-rated health question was coded using the Diehr et al. transformation (E=95/VG=90/G=80/F=30/P=15), and analyzed with change-score regression models.
The speed of processing (vs. no-contact control) group had statistically significant improvements (or protective effects) on changes in self-rated health at the 2-, 3- and 5-year follow-ups. The 5-year improvement was 2.8 points (p = .03). No significant differences were observed in the memory or reasoning groups at any time.
The speed of processing intervention significantly protected self-rated health in ACTIVE, with the average benefit equivalent to half the difference between excellent vs. very good health.
randomized controlled trial; cognitive training; self-rated health; memory; reasoning; speed of processing
Background and Purpose
Urodynamic studies (UDS) are routinely obtained prior to surgery for stress urinary incontinence (SUI) despite a lack of evidence that UDS information has an actual impact on outcome. The primary aim of this non-inferiority randomized clinical trial is to determine whether women with symptomatic, uncomplicated SUI who undergo only a basic office evaluation (BOE) prior to SUI surgery (No UDS arm) have non-inferior treatment outcomes compared to women who have BOE and UDS (UDS arm). Secondary aims are: 1) to determine how often physicians use preoperative UDS results to alter clinical and surgical decision-making, 2)to compare the amount of improvement in incontinence outcomes, and 3) to determine the incremental cost and utility of performing UDS compared with not performing UDS
After an initial basic office evaluation, women planning surgery for uncomplicated SUI who consent to study participation will be randomized to receive preoperative UDS or No UDS. Treatment will be planned and performed by the surgeon utilizing all the data available to them. We will compare results from the basic office evaluation (No UDS) with results from the basic office evaluation and preoperative UDS.
The primary outcome will be measured at 12 months using responses to the Urogenital Distress Inventory and the Patient Global Index – Improvement.
Randomized trials comparing the effects of different diagnostic alternatives on treatment outcomes pose study design challenges. A non-inferiority design is appropriate when comparing a less invasive and less expensive alternative with a standard of care approach.
Randomized trial; Stress Urinary Incontinence; Urodynamic studies; Non-inferiority trial
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
Midurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications.
We performed a multicenter, randomized equivalence trial comparing outcomes with retropubic and transobturator midurethral slings in women with stress incontinence. The primary outcome was treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment). The predetermined equivalence margin was ±12 percentage points.
A total of 597 women were randomly assigned to a study group; 565 (94.6%) completed the 12-month assessment. The rates of objectively assessed treatment success were 80.8% in the retropubic-sling group and 77.7% in the transobturator-sling group (3.0 percentage-point difference; 95% confidence interval [CI], −3.6 to 9.6). The rates of subjectively assessed success were 62.2% and 55.8%, respectively (6.4 percentage-point difference; 95% CI, −1.6 to 14.3). The rates of voiding dysfunction requiring surgery were 2.7% in those who received retropubic slings and 0% in those who received transobturator slings (P = 0.004), and the respective rates of neurologic symptoms were 4.0% and 9.4% (P = 0.01). There were no significant differences between groups in postoperative urge incontinence, satisfaction with the results of the procedure, or quality of life.
The 12-month rates of objectively assessed success of treatment for stress incontinence with the retropubic and transobturator approaches met the prespecified criteria for equivalence; the rates of subjectively assessed success were similar between groups but did not meet the criteria for equivalence. Differences in the complications associated with the two procedures should be discussed with patients who are considering surgical treatment for incontinence. (ClinicalTrials.gov number, NCT00325039.)
We evaluated the effects of the 3 cognitive interventions fielded in the Advanced Cognitive Training for Independent and Vital Elderly study on 2 subsets of participants—1,606 without and 424 with suspected clinical depression at baseline. In the former group, only the speed of processing (vs. no-contact control) intervention had a significant effect, with its participants being 38% less likely to develop suspected clinical depression at 1 year (adjusted odds ratio = 0.62; p < .01). None of the interventions had a significant effect on recovery from suspected clinical depression in the latter group. Although the etiological mechanism of the speed of processing’s protective effect was not isolated, it may result from successful adaptation to age-related changes through selective optimization with compensation.
ACTIVE; Depression; Randomized controlled trial; Speed of processing