Ecological momentary assessment of pelvic pain and urinary urgency variability in urologic chronic pelvic pain syndrome and their association with illness impact and quality of life: Findings from the multidisciplinary approach to the study of chronic pelvic pain symptom patterns study.

PURPOSE: This study tested the hypothesis that ecological momentary assessment (EMA) of pelvic pain (PP) and urinary urgency (UU) would reveal unique Urologic Chronic Pelvic Pain Syndrome (UCPPS) phenotypes that would be associated with disease specific quality of life (QOL) and illness impact metrics (IIM). MATERIALS AND METHODS: A previously validated smart phone app (M-app) was provided to willing Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) participants. M-app notifications were sent 4-times daily for 14 days inquiring about PP and UU severity. A clustering algorithm that accounted for variance placed participants into PP and UU variability? clusters. Associations between clusters and QOL and IIM were then determined. RESULTS: A total of 204 participants enrolled in the M-app study (64% female). M-app compliance was high (median 63% of surveys). Cluster analysis revealed k = 3 (high, low, none) PP clusters and k = 2 (high, low) UU clusters. When adjusting for baseline pain severity, high PP variability, but not UU variability, was strongly associated with QOL and IIM; specifically worse mood, worse sleep and higher anxiety. UU and PP clusters were associated with each other (p < 0.0001), but a large percentage (33%) of patients with high PP variability had low UU variability. CONCLUSIONS: PP variability is an independent predictor of worse QOL and more severe IIM in UCPPS participants after controlling for baseline pain severity and UU. These findings suggest alternative pain indices, such as pain variability and unpredictability, may be useful adjuncts to traditional measures of worst and average pain when assessing UCPPS treatment responses.

Comprehensive pelvic muscle assessment: Developing and testing a dual e-Learning and simulation-based training program.

OBJECTIVE: The Prevention of Lower Urinary Tract Symptoms (PLUS) research consortium launched the RISE FOR HEALTH (RISE) national study of women's bladder health which includes annual surveys and an in-person visit. For the in-person exam, a standardized, replicable approach to conducting a pelvic muscle (PM) assessment was necessary. The process used to develop the training, the products, and group testing results from the education and training are described. METHODS: A comprehensive pelvic muscle assessment (CPMA) program was informed by literature view and expert opinion. Training materials were prepared for use on an electronicLearning (e-Learning) platform. An in-person hands-on simulation and certification session was then designed. It included a performance checklist assessment for use by Clinical Trainers, who in collaboration with a gynecology teaching assistant, provided an audit and feedback process to determine Trainee competency. RESULTS: Five discrete components for CPMA training were developed as e-Learning modules. These were: (1) overview of all the clinical measures and PM anatomy and examination assessments, (2) visual assessment for pronounced pelvic organ prolapse, (3) palpatory assessment of the pubovisceral muscle to estimate muscle integrity, (4) digital vaginal assessment to estimate strength, duration, symmetry during PM contraction, and (5) pressure palpation of both myofascial structures and PMs to assess for self-report of pain. Seventeen Trainees completed the full CPMA training, all successfully meeting the a priori certification required pass rate of 85% on checklist assessment. CONCLUSIONS: The RISE CPMA training program was successfully conducted to assure standardization of the PM assessment across the PLUS multicenter research sites. This approach can be used by researchers and healthcare professionals who desire a standardized approach to assess competency when performing this CPMA in the clinical or research setting.

The RISE FOR HEALTH study: Methods for in-person assessment and biospecimen collection.

OBJECTIVES: To describe the methods for the in-person assessment of the RISE FOR HEALTH (RISE) study, a population-based multicenter prospective cohort study designed to identify factors that promote bladder health and/or prevent lower urinary tract symptoms in adult women, conducted by the Prevention of Lower Urinary Tract Symptoms Research Consortium (PLUS). METHODS AND RESULTS: A subset of RISE participants who express interest in the in-person assessment will be screened to ensure eligibility (planned n = 525). Eligible consenting participants are asked to complete 15 physical assessments in addition to height and weight, to assess pelvic floor muscle function, musculoskeletal (MSK) status, and pain, and to provide urogenital microbiome samples. Pelvic floor muscle assessments include presence of prolapse, strength, levator attachment integrity (tear) and myofascial pain. MSK tests evaluate core stability, lumbar spine, pelvic girdle and hip pain and function. Participants are asked to complete the Short Physical Performance Battery to measure balance, lower extremity strength, and functional capacity. All participants are asked to provide a voided urine sample and a vaginal swab for microbiome analyses; a subset of 100 are asked to contribute additional samples for feasibility and validation of a home collection of urinary, vaginal, and fecal biospecimens. RESULTS: Online and in-person training sessions were used to certify research staff at each clinical center before the start of RISE in-person assessments. Standardized protocols and data collection methods are employed uniformly across sites. CONCLUSIONS: The RISE in-person assessment is an integral portion of the overall population-based RISE study and represents an innovative approach to assessing factors hypothesized to promote bladder health and/or prevent lower urinary tract symptoms. Data collected from this assessment will be used to prioritize future research questions and prevention strategies and interventions. This description of the assessment methods is intended to provide methodologic transparency and inform other researchers who join efforts to understand and improve bladder health.

The RISE FOR HEALTH study: Methods for in-person musculoskeletal assessment.

OBJECTIVES: To describe the methods for the in-person musculoskeletal (MSK) assessment of the RISE FOR HEALTH (RISE) study, a population-based multicenter prospective cohort study designed to identify factors associated with bladder health (BH) conducted by the Prevention of Lower Urinary Tract Symptoms Research Consortium (PLUS). METHODS: A subset of RISE participants who express interest in the in-person assessment are screened to ensure eligibility (planned n = 525). Eligible consenting participants are asked to complete a standardized MSK assessment to evaluate core stability (four component core stability test, lumbar spine pain (seated slump test), pelvic girdle pain, (sacroiliac joint, anterior superior iliac spine, pubic symphysis tenderness, and pelvic girdle pain provocation test), hip pain (flexion, abduction, internal rotation and flexion, adduction and external rotation) and pelvic girdle function (active straight leg raise). Participants are also asked to complete the Short Physical Performance Battery to measure balance, gait speed, lower extremity strength, and functional capacity. RESULTS: Detailed online and in-person MSK training sessions led by physical therapy were used to certify research staff at each clinical center before the start of RISE in-person assessments. All evaluators exceeded the pre-specified pass rates. CONCLUSIONS: The RISE in-person MSK assessment will provide further insight into the role of general body MSK health and dysfunction and the spectrum of BH.

Results of the patient report of intermittent catheterization experience (PRICE) study.

AIMS: Patient satisfaction is paramount to health-related quality of life (HR-QoL) outcomes. High quality, quantitative data from the US describing patients' actual experiences, difficulties, and HR-QoL while on an intermittent self-catheterization (ISC) regimen is very scarce. Our objective was to better understand patient practices with and attitudes towards ISC. METHODS: This is a cross-sectional, multi-centered, clinical study of adult men and women performing ISC in the United States. Data collected included demographics, medical history, catheter characteristics, specific self-catheterization habits and two validated HR-QoL questionnaires: The Intermittent Self-Catheterization Questionnaire (ISC-Q) and the Intermittent Catheterization Difficulty Questionnaire (ICDQ). RESULTS: Two hundred participants were recruited from six sites; 70.0% were male, 73.5% were Caucasian with a median age was 51.0 years (range 19-90 years). The ISC-Q showed that the vast majority of participants reported ease with ISC (82.0% satisfaction score) had confidence in their ability to perform ISC (91.9% satisfaction score); yet, many felt self-conscious about doing so (58.3% satisfaction score) and had concerns about long-term adverse effects (58.1% satisfaction score). The ICDQ indicated little to no difficulty for most participants with all routine ISC practices. A small minority of participants reported some difficulty with a "blocking sensation" during initiation of catheterization, leg spasticity, and painful catheterization. Multivariate linear regression results are also reported. DISCUSSION/CONCLUSION: Participants are confident with ISC and have little overall difficulty, which may be a product of successful education and/or catheter design. urinary tract infections (UTIs) were common (yet variable) and may contribute to the noted long-term ISC concerns. Limitations exist including various selection biases leading to concerns of external validity. Future educational interventions in this population may further improve HR-QoL, optimize UTIs prevention, and diminish concerns with long-term ISC.

Patient-Centered Preference Assessment to Improve Satisfaction With Care Among Patients With Localized Prostate Cancer: A Randomized Controlled Trial.

PURPOSE: To study the effectiveness of the Patient Preferences for Prostate Cancer Care (PreProCare) intervention in improving the primary outcome of satisfaction with care and secondary outcomes of satisfaction with decision, decision regret, and treatment choice among patients with localized prostate cancer. METHODS: In this multicenter randomized controlled study, we randomly assigned patients with localized prostate cancer to the PreProCare intervention or usual care. Outcomes were satisfaction with care, satisfaction with decision, decision regret, and treatment choice. Assessments were performed at baseline and at 3, 6, 12, and 24 months, and were analyzed using repeated measures. We compared treatment choice across intervention groups by prostate cancer risk categories. RESULTS: Between January 2014 and March 2015, 743 patients with localized prostate cancer were recruited and randomly assigned to receive PreProCare (n = 372) or usual care (n = 371). For the general satisfaction subscale, improvement at 24 months from baseline was significantly different between groups (P < .001). For the intervention group, mean scores at 24 months improved by 0.44 (SE, 0.06; P < .001) from baseline. This improvement was 0.5 standard deviation, which was clinically significant. The proportion reporting satisfaction with decision and no regret increased over time and was higher for the intervention group, compared with the usual care group at 24 months (P < .05). Among low-risk patients, a higher proportion of the intervention group was receiving active surveillance, compared with the usual care group (P < .001). CONCLUSION: Our patient-centered PreProCare intervention improved satisfaction with care, satisfaction with decision, reduced regrets, and aligned treatment choice with risk category. The majority of our participants had a high income, with implications for generalizability. Additional studies can evaluate the effectiveness of PreProCare as a mechanism for improving clinical and patient-reported outcomes in different settings.

"A secret club": focus groups about women's toileting behaviors.

BACKGROUND: Understanding reasons for and impact of women's toileting behaviors on bladder health is important to prevent and manage urinary incontinence (UI) and overactive bladder (OAB). METHODS: Women, regardless of urinary incontinence (UI) and overactive bladder (OAB) status, were recruited in Pennsylvania and North Carolina. Focus groups were conducted by trained female moderators and sessions were audiotaped. Participants completed an anonymous questionnaire containing validated items to determine the presence of UI and OAB. Audiotapes were transcribed and content was analyzed by two investigators to identify themes. RESULTS: Twenty-four women participated (mean age 68 ± 13.4 years); most had UI (75%) or OAB (87.5%). Many women had difficulty in describing bladder health, and talked about bladder function, diseases or conditions, and control over the bladder. Four themes about toileting emerged: 1) cues/triggers/alerts women used to find and use toilets, 2) toilet cleanliness away from and at home, 3) toileting as a nuisance, and 4) situational awareness. Women described internal (e.g., sensation of heaviness) and external cues/triggers/alerts (e.g., walking by restrooms), and the trade-off between their concerns about public toilet cleanliness and the need to urinate. Some women expressed being irritated or annoyed about having to stop activities to urinate. Most women reported sitting on their home toilets, whereas, many hovered or stood over the toilet in public places. CONCLUSIONS: The information gained from this study will facilitate the development of relevant public health messaging and interventions to raise public awareness about UI, OAB, and bladder health with the aim to encourage women to seek help when symptoms are present.

Costs and Sustainability of a Behavioral Intervention for Urinary Incontinence Prevention.

INTRODUCTION: Many women choose behavioral interventions as first line treatment for urinary incontinence. We developed a 20-minute abbreviated video, which proved to be similar to a 2-hour in-person class in a randomized trial. This study examines economic end points for the 20-minute video relative to the 2-hour class. METHODS: We randomized 332 participants to the 2-hour class and 315 to the 20-minute video. We estimated the cost for the 2-hour class, the 20-minute video and followup health care utilization. Participants were followed for 3, 12 and 24 months, and asked about health care utilization, quality of life and lost productivity. To measure perceived value, we queried each participant regarding willingness to pay. Regression analysis was used for statistical comparisons. RESULTS: The estimated per participant cost for a 2-hour class was $38, which was more than the marginal cost of the video ($0). We found no significant differences between the treatment groups at each followup for quality of life, lost productivity or health care utilization. Women were willing to pay $26, $21 and $30 for a copy of the DVD, video on the Web and in-person class, respectively, all of which were less than the average cost of the in-person class ($38). CONCLUSIONS: Poor adherence remains a challenge for many behavioral interventions designed to prevent urinary incontinence. The 20-minute video is less expensive than the 2-hour class and is equally effective. Distributing the video on the Internet will improve access and will be easier to sustain than in-person classes.

Clean intermittent catheterization revisited.

Catheterization is the insertion of a hollow flexible tube (called a catheter) to drain the urine from the bladder and is probably one of the oldest urologic procedures, dating back 3000 years. Since 1972, when urologist Dr Jack Lapides described a procedure for performing clean intermittent catheterization, this method of bladder management has become lifesaving for an individual who cannot empty their bladder independently. If the bladder is not emptied regularly, elevated storage pressures can develop which may put the upper tracts at risk of subsequent deterioration. Intermittent catheterization (IC) has become the first-line and preferred method of drainage in patients with neurogenic lower urinary tract dysfunction, as long as dexterity or available caregiver support and body habitus allow access. However, over the past 20 years, an evolution has occurred in the technology of catheters used for IC. But with these advances, so has controversy arisen. This article is a review of the current application of IC, the current technology in catheter material and systems, differences between reusable and one-time, or single-use catheters, the cost benefit of doing IC, and the infectious benefit.

Internal and external urinary catheters: a primer for clinical practice.

Internal and external urinary catheters are used to manage urinary incontinence and incomplete bladder emptying. Bladder dysfunction cause determines whether short- or long-term catheter use is required which, in turn, determines whether an indwelling, intermittent, or external catheter should be used. The method of catheterization is based on the underlying bladder condition, the goals of treatment, and gender appropriateness. Complications such as infection (eg, catheter-associated urinary tract infection, sepsis) and its related sequelae have been found to be directly related to length of time of catheter use (eg, women are at greater risk for catheter-associated urinary tract infection when an indwelling catheter is in place >2 weeks); thus, catheter use must be medically justified and in the case of an indwelling catheter, involve the shortest period possible to ensure patient safety and regulatory compliance. Some newer catheter systems include coatings to prevent complications; complications specific to indwelling catheter use include obstruction from encrustations, urethral trauma and erosion, bladder stones and bladder cancer, and, in men, epididymitis. Complications from external catheters may occur when skin condition is compromised. Overuse of catheters has reimbursement ramifications. Numerous guidelines reflect the need for the judicious use of urinary catheters, particularly in long-term care patients. Because evidence-based research on long-term use of these devices is lacking, clinicians should use clinical experience when caring for patients with catheters.

The MATRIX study: assessment of health-related quality of life in adults with the use of transdermal oxybutynin.

This article provides an overview of the results of the MATRIX study. Subsequent articles will provide more detailed results of other findings in this study. Overall, this study found that OXY-TDS administration resulted in improvement in HRQoL, with the medication having its greatest effect on the impact of incontinence, severity of symptoms, and role limitations. OXY-TDS was well tolerated, with a low prevalence of anticholinergic adverse events noted. The next article will focus on results in populations older than 65 years and in those older than 80 years.

Overactive bladder: recognition requires vigilance for symptoms.

Overactive bladder (OAB) is a prevalent condition in both men and women that imposes significant burdens on the patient and his or her quality of life. Nevertheless, only a small percentage of patients with OAB receive diagnosis and treatment. The identification of OAB is well within the scope of the primary care provider, as it is symptom-based and does not generally require specialized testing. The treatment of OAB relies on behavioral modification and/or pharmacologic options, primarily antimuscarinic therapy. Better identification of OAB symptoms in the primary care setting should reduce the number of patients suffering from untreated OAB.

Innovation in bladder assessment: use of technology in extended care.

Nursing homes are required to conduct a comprehensive assessment and screening of residents with urinary incontinence (UI) and indwelling catheter upon admission, and if there is a change in cognition, physical ability, or urinary tract function (Centers for Medicare and Medicaid Services [CMS], 2005). The desired goal is to improve the quality of care through the maintenance and the restoration of bladder function. CMS regulations and revised Tag F315 mandate that long-term care facilities appropriately assess and treat the specific bladder disorder of UI and decrease the inappropriate use of indwelling urinary catheters. Assessment includes evaluation for reversible factors that may cause UI, such as urinary retention and urinary tract infection. The scope of this article is to demonstrate the relationship between these bladder disorders and assessments that can be performed by nursing staff. Because invasive instrumentation of the bladder can increase the likelihood of urinary tract infections, the use of non-invasive technology that ensures quality and evidence-based clinical practice, while preventing associated medical problems in vulnerable residents, is necessary for bladder assessment in the extended care setting. With this technology, assessment of bladder function is easy for staff and provides information that can be vital to successful nursing care outcomes. The staff of CRISTA Senior Community changed clinical practice through incorporation of technology to determine the presence of bladder dysfunction. Staff accurately and effectively applied ultrasonography to determine the bladder volume and abnormalities with bladder emptying, with ultimate improvement in resident care. Adoption of technology can preserve the resident's dignity and respect, while ensuring the highest level of bladder function.

Assessment of diaper-clogging potential of petrolatum moisture barriers.

Petrolatum-based ointments often are used to treat and prevent incontinence dermatitis. However, anecdotal reports indicate that petrolatum ointments may affect the absorbency of disposable briefs also commonly used in incontinence management. To examine whether petrolatum ointments clog a commonly used absorbent brief, a randomized, balanced-block design study was conducted in a controlled laboratory setting to compare the brief-clogging potential of three petrolatum ointments to a non-alcohol barrier film. Test products were applied to 6-cm x 6-cm test sites on the volar forearms of 16 volunteers. Pre-weighed mini briefs were applied to the test sites in a manner that simulates normal brief wear. After 5 minutes of wear, the mini briefs were weighed to determine percent of product transfer from skin to mini brief. The mini briefs then were reapplied to the same test sites and a synthetic urine solution was introduced between the skin and the mini brief. Mini briefs subsequently were removed to determine fluid uptake by weight. Results indicate significant differences between the four test products (P < 0.01) both in percent transfer and in mini brief fluid absorption. From 59% to 69% of the petrolatum-based products transferred from the skin to the mini briefs and a 54% to 90% reduction in fluid uptake was noted, as determined by weight. The non-alcohol barrier film did not transfer to the mini brief and fluid uptake was minimally affected. Further study in the clinical and practice settings to determine the effect and consequences of barrier product transfer on absorbent garments is warranted.

Managing incontinence using technology, devices, and products: directions for research.

BACKGROUND: Millions of Americans with incontinence use some type of device or product to manage or collect urine or feces. However, research on their clinical uses, problems requiring nursing care, and patient satisfaction is lacking. OBJECTIVES: To review the various products and devices used for incontinence, identify directions for research and development on technology, and outline the ways nurses can influence and participate in those investigations. METHODS: Existing literature on incontinence technology, devices, and products was analyzed to generate a plan for future research. RESULTS: Gaps in knowledge exist about the uses, best practices, quality of life factors, and problems associated with catheters, absorbent products, other internal and external devices, and skin care products. CONCLUSIONS: Collaboration among public and private sectors would result in greater likelihood of high quality clinical research that has sufficient power and integrity, more efficient use of resources special to each setting, and expedited application of technologies for patient use.