A digital health program for treatment of urinary incontinence: retrospective review of real-world user data.

INTRODUCTION AND HYPOTHESIS: To determine the effectiveness of a prescription digital therapeutic (pDTx) in reducing urinary incontinence (UI) symptoms in real-world users. METHODS: This is a retrospective cohort study of real-world data from users of a pDTx designed to guide pelvic floor muscle training(PFMT) between July 1, 2020-December 31, 2021. The primary outcome was UI symptom change as reported via in-app Urogenital Distress Inventory (UDI-6). Included subjects were female, ≥ 18 years with a diagnosis of stress, urgency, or mixed UI who completed the UDI-6 at baseline and 8 weeks. Demographic, symptom, and adherence data were summarized. Paired t-test and Wilcoxon signed rank test were used to analyze change in outcomes from baseline to 8 weeks across adherence and UI diagnosis groups. RESULTS: Of 532 women with UI, 265 (50%) met criteria and were included in the analysis. Mean age was 51.2 ± 11.5 years (range 22-84, N = 265). Mean body mass index (BMI) was 27.3 ± 6.2 kg/m2 (range 15.2-46.9, N = 147). Most participants had stress UI (59%) followed by mixed UI (22%), urgency UI/OAB (11%), and unspecified UI (8%). UDI-6 scores improved by 13.90 ± 15.53 (p ≤ 0.001); 62% met or exceeded MCID. Device-reported PFMT adherence was 72% at 4 weeks and 66% at 8 weeks (100% = 14 uses/week). Participants in each diagnosis category reported significant improvement on UDI-6 score from baseline to 8 weeks. No association between UDI-6 score improvement and adherence category, age, BMI, or UI subtype was identified. CONCLUSIONS: This study demonstrates effectiveness of a pDTx in reducing UI symptoms in a real-world setting. Users achieved statistically and clinically significant symptom improvement over an 8-week period.

Healthcare resource use and cost burden of urinary incontinence to United States payers.

OBJECTIVE: To assess healthcare resource utilization and costs for female patients diagnosed with stress or mixed urinary incontinence (SUI/MUI) compared to a matched cohort of patients without SUI/MUI. METHODS: We conducted a retrospective matched cohort study of women using the IBM MarketScan research database. Women diagnosed with SUI/MUI between July 1, 2014 and June 30, 2016 were identified using International Classification of Diseases 9 and 10 codes for SUI or MUI with the date of first diagnosis as the index date from which 2-year postindex healthcare resource use and direct cost data were derived from claims, examined, and compared 1:1 with patients without a SUI/MUI diagnosis, matched by age and Charlson's Comorbidity Index. RESULTS: A total of 68 636 women with SUI/MUI were matched 1:1 with controls. In the 2-year postindex date, a significantly higher proportion of SUI/MUI patients had ≥1 inpatient visit and ≥1 outpatient visit compared to the control group (inpatient: 18.89% vs. 12.10%, p < 0.0001; outpatient: 88.44% vs. 73.23%, p < 0.0001). Mean primary care visits were significantly higher in SUI/MUI patients compared to controls (7.33 vs. 5.53; p < 0.0001) as were specialist visits (1.2 vs. 0.08; p < 0.0001). Mean all-cause outpatient costs were higher in SUI/MUI patients compared to controls ($7032.10 vs. $3348.50; p < 0.0001), as were inpatient costs ($3990.70 vs. $2313.70; p < 0.0001). CONCLUSION: Women with SUI/MUI consume significantly higher medical resources and incur higher costs to payers, compared to women without SUI/MUI. While reasons for this are not fully understood, improved and standardized treatment for women with SUI/MUI may positively affect cost and outcomes.

Adherence to professional society guidelines among women with stress or mixed urinary incontinence.

AIMS: The objective of this analysis was to describe longitudinal adherence with recommended urinary incontinence (UI) evaluation and treatment guidelines over a 2-year period in patients newly diagnosed with stress (SUI) or mixed UI (MUI), and average 2-year cost associated with initial treatment. METHODS: A retrospective claims analysis using the IBM MarketScan database was conducted. Women diagnosed with SUI/MUI between July 1, 2014 and June 30, 2016 were identified using the International Classification of Diseases (ICD) 9 and 10 codes for SUI or MUI. Newly diagnosed SUI/MUI patients who did not have a UI-related diagnosis for at least 1 year before their index date were assessed. RESULTS: 103 813 patients with newly diagnosed SUI or MUI were identified. Of those, 96.15% (99 821/103 813) received an initial evaluation in accordance with professional guidelines (e.g., patient history, physical examination, urinalysis). Only 6.8% (5086/74 925) and 7.7% (2229/28 888) of patients with SUI and MUI, respectively, received a first-line behavioral treatment (e.g., pelvic floor muscle exercises, bladder training), according to guidelines. The 2-year average UI-related medical costs associated with guideline adherence for SUI were $5770.93 ± $9454.81 and for MUI, $4416.16 ± $7401.53. Nonadherence was observed in 59.2% (44 382/74 925) of SUI and 64.1% (18 530/28 888) of MUI patients. Two-year average UI-related medical costs for the nonadherent group were $8568.00 ± $11 275.52 for SUI and $6986.66 ± $10 765.55 for MUI, significantly more than the adherent group (p < 0.0001). CONCLUSION: The majority of SUI or MUI patients do not receive a documented behavioral intervention as their first-line treatment, which is a recommendation by professional society guidelines. This was found to affect the cost burden for payers; those that were nonadherent had significantly higher costs 2-year postindex.

Retrospective claims analysis of physical therapy utilization among women with stress or mixed urinary incontinence.

OBJECTIVE: To describe the characteristics of women with stress or mixed urinary incontinence (SUI/MUI) receiving physical therapy (PT) services, including referral patterns and PT utilization. METHODS: Female patients with claims associated with an SUI or MUI diagnosis (International Classification of Disease-Clinical Modification [ICD-9-CM]: 625.6, 788.33, or ICD-10-CM: N39.3, N39.46) between July 01, 2014 and June 30, 2016 were identified in International business machines (IBM)'s MarketScan Research Database. Inclusion criteria included the absence of pregnancy claims and ≥80% medical and pharmacy enrollment pre- and postindex. First SUI/MUI diagnosis claim determined index. Patients were followed for 2 years, and associated UI-associated PT encounters were identified. Descriptive statistics were calculated for patients with at least one PT visit during the postindex period. RESULTS: In a cohort of 103,813 women with incident SUI or MUI diagnosis, 2.6% (2792/103,813) had at least one PT visit in the 2 years following their diagnosis. Mean age at index PT encounter was 50.55 years. A total of 52.36% (1462/2792) women had one to four PT visits; 21.2% (592/2792) had >8 PT visits. In subanalysis of the PT cohort (1345/2792), women who received PT only had the lowest average 2-year postindex total medical cost (mean: $12,671; SD: $16,346), compared with PT plus medications (mean: $27,394; SD: $64,481), and PT plus surgery (mean: $33,656; SD: $26,245), respectively. Over 40% had their first PT visit ≥3 months after their index date. CONCLUSIONS: The percentage of women with a PT visit associated with an incident SUI or MUI diagnosis was low (2.6%), and 30% of this group completed three or more PT visits. This suggests poor adherence to clinical guidelines regarding supervised treatment of UI in women. IMPACT STATEMENT: Our study suggests underutilization of PT among insured women with SUI and MUI in the 2 years following diagnosis. Interventions to improve this gap in first-line care may represent an opportunity for an increased role for PTs in the care of women with UI.

Female Urinary Incontinence Evidence-Based Treatment Pathway: An Infographic for Shared Decision-Making.

Objectives: Urinary incontinence (UI) is a highly prevalent burdensome condition among adult females in the United States, yet rates of care-seeking, evaluation, and treatment are nonoptimal. Components of evaluation and treatment are informed by research and professional society guidelines; however, a visual representation of this guidance does not exist. The objectives of this study are to review the literature regarding female UI care and to synthesize this information into a graphical format to facilitate health education, health care delivery, and shared decision-making. Methods: We reviewed published society guidelines, position statements, and associated references from the American College of Obstetrics and Gynecology, the Women's Preventive Services Initiative, American Academy of Family Physicians, American College of Physicians, the Society of Urodynamics and Female Urology, the American Urological Association, and the American Urogynecologic Society, and searched PubMed for related literature. We synthesized these findings into an evidence-based infographic depicting female UI risk factors, influences on care-seeking and provision, screening, evaluation, and a stepwise treatment approach. Results: This study summarizes current evidence and professional guidelines related to female UI into a compelling visual format and accompanying narrative. The infographic is intended as a tool for patient education, clinical practice, and research to facilitate shared decision-making and health care delivery. Conclusions: Female UI is highly prevalent, yet diagnosis and treatment are suboptimal. Use of an evidence-based infographic may positively impact patient knowledge and certainty about UI treatment and support health care provider counseling and decision-making.

Prevalence of urinary incontinence in pregnant and postpartum women in the Democratic Republic of Congo.

INTRODUCTION AND HYPOTHESIS: The objective was to describe the prevalence of urinary incontinence in pregnant and postpartum women in the Democratic Republic of Congo and to identify factors associated with urinary incontinence (UI) in these populations. METHODS: We interviewed eligible women who sought prenatal or postnatal reproductive health clinic consultations over a 2-year period. Interviews collected information about demographics, obstetric history, and urinary incontinence symptoms, as well as the impact on the quality of life, via a validated questionnaire. Descriptive analyses compared women with and without urinary incontinence and compared characteristics of UI, stratified by pregnancy status. Logistic regression identified factors associated with UI among the entire sample, pregnant women, and postpartum women. RESULTS: Overall, 268 out of 880 women had UI (30.5%); the prevalence was 33.4% (168 out of 503) among pregnant women and 26.5% (100 out of 377) among postpartum women, p = 0.03. Women who were pregnant were significantly more likely to experience stress incontinence (p = 0.01) and less likely to report moderate or large amounts of leakage (p = 0.002). A history of macrosomia and being currently pregnant were associated with UI in the entire sample (p < 0.05). Among pregnant women, the risk of UI decreased with increasing gestational age and increased with a history of macrosomia (p ≤ 0.01). Among postpartum women, a history of macrosomia and prior episiotomy were associated with UI (p < 0.05). CONCLUSIONS: Urinary incontinence is prevalent in pregnant and postpartum women in the Democratic Republic of Congo and is associated with a history of macrosomia. Efforts should focus on screening, evaluation, and treatment.

Pelvic Floor Symptoms and Spinal Curvature in Women.

OBJECTIVES: To characterize the association between thoracic (T) and lumbar (L) spinal curvature and pelvic floor (PF) symptoms (pelvic organ prolapse, urinary incontinence [UI], fecal incontinence [FI]). METHODS: Of women undergoing a bone mineral density scan from January 2007 to October 2010, patients who completed PF symptom questionnaires and had T and/or L spine radiographs or computed tomography examinations within 3 years of questionnaire completion were included in this study. The spine angles were measured using the Cobb angle method. The T and L curvatures were categorized as hypokyphosis (<20°), normal T kyphosis (20-40°), hyperkyphosis (>40°), hypolordosis (<40°), normal L lordosis (40-70°), and hyperlordosis (>70°). The presence and type of UI were identified with the 3 Incontinence Questionnaire and FI with the Modified Manchester Questionnaire. Pelvic organ prolapse was defined as a positive response to the presence of a bulge question from the PF Distress Inventory-20. RESULTS: Of 1665 eligible women, 824 and 302 (mean age 64 ± 10 for both) had T and L spine images, respectively. No differences in PF symptoms were observed in the T or L spine groups categorized by hypo-, normal, and hyperkyphosis/lordosis except for urgency UI being more prevalent in the hypolordosis group (P = 0.01). However, upon further characterization using logistic regression, no association was noted between PF symptoms and T or L spine angles; no differences in the mean angles were found between women with versus without PF symptoms (P ≥ 0.05). CONCLUSIONS: The current study shows that the T and L spinal curvatures are not associated with the presence of PF symptoms.

Pelvic Floor Physical Therapy as Primary Treatment of Pelvic Floor Disorders With Urinary Urgency and Frequency-Predominant Symptoms.

OBJECTIVE: To assess the efficacy of pelvic floor physical therapy (PFPT) as primary treatment of urinary urgency and frequency symptoms METHODS: We conducted a prospective cohort study of women with urinary urgency and frequency symptoms. Participants underwent PFPT once or twice per week for 10 weeks. Symptom improvement was assessed by validated questionnaires (Pelvic Floor Distress Inventory-Short Form 20 and Patient Global Impression of Improvement), voiding diaries, and subjective measures. RESULTS: Fifty-seven participants enrolled; 21 (36.8%) withdrew or completed less than 5 weeks of PFPT. Thirty-one (54.4%) of the remaining 36 participants completed 10 weeks of PFPT. The mean age of the study group (n = 36) was 48.9 ± 15.0 years. The primary diagnoses were overactive bladder syndrome (n = 24, 66.7%) and painful bladder syndrome (n = 12, 33.3%). Women attended a median of 14.0 (interquartile range [IQR], 8.0-16.0) PFPT visits over a median of 11.9 weeks (IQR, 10.0-18.1). At baseline, the median Pelvic Floor Distress Inventory-Short Form 20 score was 79.2 (IQR, 53.1-122.9), and decreased to 50.0 (IQR, 25.0-88.5; P < 0.001) after PFPT; the urinary and prolapse symptom subscales both decreased significantly. Participants reported a decrease from a median of 10.0 voids per day to 8.0 (P < 0.001). On the Patient Global Impression of Improvement, 62.5% of women reported that they were "much better" or "very much better." CONCLUSIONS: The PFPT with myofasical release techniques improves urinary symptoms while avoiding medications and more invasive therapies. The high dropout rates suggest that motivation or logistic factors may play a significant role in the utilization and success of this treatment option.

Musculoskeletal pain in gynecologic surgeons.

OBJECTIVE: To describe the prevalence of musculoskeletal pain and symptoms in gynecologic surgeons. DESIGN: Prospective cross-sectional survey study (Canadian Task Force classification II-2). SETTING: Virtual. All study participants were contacted and participated via electronic means. PARTICIPANTS: Gynecologic surgeons. INTERVENTIONS: An anonymous, web-based survey was distributed to gynecologic surgeons via electronic newsletters and direct E-mail. MEASUREMENTS AND MAIN RESULTS: There were 495 respondents with complete data. When respondents were queried about their musculoskeletal symptoms in the past 12 months, they reported a high prevalence of lower back (75.6%) and neck (72.9%) pain and a slightly lower prevalence of shoulder (66.6%), upper back (61.6%), and wrist/hand (60.9%) pain. Many respondents believed that performing surgery caused or worsened the pain, ranging from 76.3% to 82.7% in these five anatomic regions. Women are at an approximately twofold risk of pain, with adjusted odds ratios (OR) of 1.88 (95% confidence interval [CI], 1.1-3.2; p = .02) in the lower back region, OR 2.6 (95% CI, 1.4-4.8; p = .002) in the upper back, and OR 2.9 (95% CI, 1.8-4.6; p = .001) in the wrist/hand region. CONCLUSION: Musculoskeletal symptoms are highly prevalent among gynecologic surgeons. Female sex is associated with approximately twofold risk of reported pain in commonly assessed anatomic regions.

Assessing the measurement invariance of latent job satisfaction ratings across survey administration modes for respondent subgroups: a MIMIC modeling approach.

To date, many studies have assessed the measurement invariance of a wide variety of measures across Internet and paper-and-pencil conditions; however a relative dearth exists in the literature investigating measurement invariance across administration modes for differing subgroups of respondents. Using MIMIC modeling, this study assessed whether gender and age of the respondent systematically influenced responding according to administration mode above and beyond measurement invariance. Consistent with past research, this study demonstrated that job satisfaction ratings were indeed measurement invariant across Internet and paper-and-pencil conditions, however, older respondents tend to differentially rate job satisfaction according to administration mode. Implications are discussed.

Effect of backrest elevation on the development of ventilator-associated pneumonia.

BACKGROUND: Ventilator-associated pneumonia is a common complication of mechanical ventilation. Backrest position and time spent supine are critical risk factors for aspiration, increasing the risk for pneumonia. Empirical evidence of the effect of backrest positions on the incidence of ventilator-associated pneumonia, especially during mechanical ventilation over time, is limited. OBJECTIVE: To describe the relationship between backrest elevation and development of ventilator-associated pneumonia. METHODS: A nonexperimental, longitudinal, descriptive design was used. The Clinical Pulmonary Infection Score was used to determine ventilator-associated pneumonia. Backrest elevation was measured continuously with a transducer system. Data were obtained from laboratory results and medical records from the start of mechanical ventilation up to 7 days. RESULTS: Sixty-six subjects were monitored (276 patient days). Mean backrest elevation for the entire study period was 21.7 degrees . Backrest elevations were less than 30 degrees 72% of the time and less than 10 degrees 39% of the time. The mean Clinical Pulmonary Infection Score increased but not significantly, and backrest elevation had no direct effect on mean scores. A model for predicting the Clinical Pulmonary Infection Score at day 4 included baseline score, percentage of time spent at less than 30 degrees on study day 1, and score on the Acute Physiology and Chronic Health Evaluation II, explaining 81% of the variability (F=7.31, P=.003). CONCLUSIONS: Subjects spent the majority of the time at backrest elevations less than 30 degrees . Only the combination of early, low backrest elevation and severity of illness affected the incidence of ventilator-associated pneumonia.

Proteomic identification of 14-3-3 sigma as a common component of the androgen receptor and the epidermal growth factor receptor signaling pathways of the human prostate epithelial cell line M12.

The epidermal growth factor receptor and androgen receptor (AR) both play major roles in the control of prostate growth. Our hypothesis is that shared downstream components of these two signaling pathways are significant participants in androgen-independent growth. Our first objective was to identify proteins whose activation and/or expression in AR-positive prostate epithelial cells are induced by both epidermal growth factor (EGF) and dihydrotestosterone (DHT). AR expression was induced in a tumorigenic, metastatic subline of the SV40 large T-antigen immortalized human prostate epithelial subline M12 by stable transfection with human wild-type AR cDNA. These M12AR (+) cells with functional AR were treated in parallel with EGF (10 ng/ml) or DHT (10(-8) M) for 24 h before 2D gel electrophoresis and Western immunoblotting with antiphosphotyrosine monoclonal antibody. Coomassie blue-stained spots on a 2D gel run in parallel were aligned with the phosphoproteins on the Western immunoblot, and identified by matrix-assisted laser desorption ionization/time-of-flight mass spectroscopy. The most interesting of the seven proteins that appeared to be phosphorylated by these criteria was 14-3-3 protein sigma. Protein extracted after either EGF or DHT treatment, immunoprecipitated with antiphosphotyrosine monoclonal antibody, and immunoblotted by anti-14-3-3 sigma confirmed phosphorylation of 14-3-3 sigma. Addition of either DHT or EGF to the M12AR(+) cells induced subcellular migration of 14-3-3 sigma and activated a 14-3-3 sigma reporter construct. Immunohistochemical analysis revealed nuclear localization of 14-3-3 sigma in higher Gleason grade prostate cancers relative to benign glands. These findings implicate 14-3-3 sigma in the development of human prostate cancer cells and could provide a new target for intervention in prostate cancer.