Longitudinal changes in symptom-based female and male LUTS clusters.

AIMS: Lower urinary tract symptoms (LUTS) are diverse in type and variable in severity. We examined symptom change within the Symptoms of the Lower Urinary Tract Dysfunction Research Network (LURN) Observational Cohort study identified clusters over time and tested associations with treatments received. METHODS: Patient-reported LUTS and treatment data were collected at multiple time points between baseline and 12 months from the LURN Observational Cohort study. LUTS severity scores were calculated to summarize changes in symptom reporting over time in previously identified LURN clusters. Repeated measures linear regression models tested adjusted associations between cluster membership and severity scores. RESULTS: Four-hundred seventeen men and 396 women were classified into improved, unchanged, and worsened symptoms between baseline and 12 months (men: 44.1%, 40.5%, and 15.3%; women: 55.8%, 33.1%, 11.1%, respectively). Improvement in LUTS severity scores varied by cluster (estimated adjusted mean change from baseline range: -.04 change in standard deviations of severity scores (ΔSD) to -.67 ΔSD). Prostate surgery was associated with improved severity scores (-.63 ΔSD) in men, while stress incontinence surgery was associated with improved severity scores (-.88 ΔSD) in women. CONCLUSION: Symptom improvement varied by cluster indicating response to therapy differs amongst subtypes of patients with LUTS. The differential improvement of patients in clusters suggests mechanistic differences between clusters and may aid in selecting more targeted treatments in the future.

A model to predict risk of postpartum infection after Caesarean delivery.

PURPOSE: The purpose of this study is to build and validate a statistical model to predict infection after caesarean delivery (CD). METHODS: Patient and surgical variables within 30 d of CD were collected on 2419 women. Postpartum infection included surgical site infection, urinary tract infection, endomyometritis and pneumonia. The data were split into model development and internal validation (1 January-31 August; N = 1641) and temporal validation subsets (1 September-31 December; N = 778). Logistic regression models were fit to the data with concordance index and calibration curves used to assess accuracy. Internal validation was performed with bootstrapping correcting for bias. RESULTS: Postoperative infection occurred in 8% (95% CI 7.3-9.9), with 5% meeting CDC criteria for surgical site infections (SSI) (95% CI 4.1-5.8). Eight variables were predictive for infection: increasing BMI, higher number of prior Caesarean deliveries, emergent Caesarean delivery, Caesarean for failure to progress, skin closure using stainless steel staples, chorioamnionitis, maternal asthma and lower gestational age. The model discriminated between women with and without infection on internal validation (concordance index = 0.71 95% CI 0.67-0.76) and temporal validation (concordance index = 0.70, 95% CI 0.62, 0.78). CONCLUSIONS: Our model accurately predicts risk of infection after CD. Identification of patients at risk for postoperative infection allows for individualized patient care and counseling.

Controlling anal incontinence in women by performing anal exercises with biofeedback or loperamide (CAPABLe) trial: Design and methods.

The goals of this trial are to determine the efficacy and safety of two treatments for women experiencing fecal incontinence. First, we aim to compare the use of loperamide to placebo and second, to compare the use of anal sphincter exercises with biofeedback to usual care. The primary outcome is the change from baseline in the St. Mark's (Vaizey) Score 24weeks after treatment initiation. As a Pelvic Floor Disorders Network (PFDN) trial, subjects are enrolling from eight PFDN clinical centers across the United States. A centralized data coordinating center supervises data collection and analysis. These two first-line treatments for fecal incontinence are being investigated simultaneously using a two-by-two randomized factorial design: a medication intervention (loperamide versus placebo) and a pelvic floor strength and sensory training intervention (anal sphincter exercises with manometry-assisted biofeedback versus usual care using an educational pamphlet). Interventionists providing the anal sphincter exercise training with biofeedback have received standardized training and assessment. Symptom severity, diary, standardized anorectal manometry and health-related quality of life outcomes are assessed using validated instruments administered by researchers masked to randomized interventions. Cost effectiveness analyses will be performed using prospectively collected data on care costs and resource utilization. This article describes the rationale and design of this randomized trial, focusing on specific research concepts of interest to researchers in the field of female pelvic floor disorders and all other providers who care for patients with fecal incontinence.