Patricia S. Goode

Fecal Incontinence in US Adults: Epidemiology and Risk Factors

BACKGROUND & AIMS The study aims were to estimate the prevalence of different types and frequencies of fecal incontinence (FI), describe demographic factors, and identify risk factors. METHODS The National Health and Nutrition Examination Survey (NHANES) assesses health status in the civilian noninstitutionalized US population. The validated Fecal Incontinence Severity Index was added to NHANES in 2005-2006. Participants were 2229 women and 2079 men aged 20 years or older. FI was defined as accidental leakage of solid, liquid, or mucus at least once in the preceding month. Sampling weights were used to obtain prevalence estimates for the national population. Multivariate logistic regression identified independent risk factors. RESULTS The estimated prevalence of FI in noninstitutionalized US adults is 8.3% (95% confidence interval, 7.1-9.5) and consists of liquid stool in 6.2%, solid stool in 1.6%, and mucus in 3.1%. It occurs at least weekly in 2.7%. Prevalence is similar in women (8.9%) and men (7.7%) and increases with age from 2.6% in 20 to 29 year olds up to 15.3% in participants aged 70 years and older. FI is not significantly associated with race/ethnicity, education, income, or marital status after adjusting for age. Independent risk factors in women are advancing age, loose or watery stools, more than 21 stools per week, multiple chronic illnesses, and urinary incontinence. Independent risk factors in men are age, loose or watery stools, poor self-rated health, and urinary incontinence. CONCLUSIONS FI is a prevalent age-related disorder. Chronic diarrhea is a strong modifiable risk factor that may form the basis for prevention and treatment.

Combined Behavioral and Drug Therapy for Urge Incontinence in Older Women

OBJECTIVE: The purpose of this study was to examine the effects of combining behavioral treatment and drug treatment for urge incontinence in community‐dwelling older women.

Hospital-Acquired Pressure Ulcers and Risk of Death

OBJECTIVE: To evaluate the impact of in‐hospital pressure ulcer development on mortality among older, high‐risk, hospitalized patients up to 1 year post‐hospital discharge, after adjusting for baseline patient characteristics, disease severity, hospital complications, and discharge activity level.

Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial.

IMPORTANCE For patients with limited prognosis, some medication risks may outweigh the benefits, particularly when benefits take years to accrue; statins are one example. Data are lacking regarding the risks and benefits of discontinuing statin therapy for patients with limited life expectancy. OBJECTIVE To evaluate the safety, clinical, and cost impact of discontinuing statin medications for patients in the palliative care setting. DESIGN, SETTING, AND PARTICIPANTS This was a multicenter, parallel-group, unblinded, pragmatic clinical trial. Eligibility included adults with an estimated life expectancy of between 1 month and 1 year, statin therapy for 3 months or more for primary or secondary prevention of cardiovascular disease, recent deterioration in functional status, and no recent active cardiovascular disease. Participants were randomized to either discontinue or continue statin therapy and were monitored monthly for up to 1 year. The study was conducted from June 3, 2011, to May 2, 2013. All analyses were performed using an intent-to-treat approach. INTERVENTIONS Statin therapy was withdrawn from eligible patients who were randomized to the discontinuation group. Patients in the continuation group continued to receive statins. MAIN OUTCOMES AND MEASURES Outcomes included death within 60 days (primary outcome), survival, cardiovascular events, performance status, quality of life (QOL), symptoms, number of nonstatin medications, and cost savings. RESULTS A total of 381 patients were enrolled; 189 of these were randomized to discontinue statins, and 192 were randomized to continue therapy. Mean (SD) age was 74.1 (11.6) years, 22.0% of the participants were cognitively impaired, and 48.8% had cancer. The proportion of participants in the discontinuation vs continuation groups who died within 60 days was not significantly different (23.8% vs 20.3%; 90% CI, -3.5% to 10.5%; P=.36) and did not meet the noninferiority end point. Total QOL was better for the group discontinuing statin therapy (mean McGill QOL score, 7.11 vs 6.85; P=.04). Few participants experienced cardiovascular events (13 in the discontinuation group vs 11 in the continuation group). Mean cost savings were

Changes in urinary and fecal incontinence symptoms with weight loss surgery in morbidly obese women.

3.37 per day and

Prevalence and Correlates of Fecal Incontinence in Community‐Dwelling Older Adults

716 per patient. CONCLUSIONS AND RELEVANCE This pragmatic trial suggests that stopping statin medication therapy is safe and may be associated with benefits including improved QOL, use of fewer nonstatin medications, and a corresponding reduction in medication costs. Thoughtful patient-provider discussions regarding the uncertain benefit and potential decrement in QOL associated with statin continuation in this setting are warranted. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01415934.

Preoperative Biofeedback Assisted Behavioral Training to Decrease Post-Prostatectomy Incontinence: A Randomized, Controlled Trial

OBJECTIVE: To examine changes in the prevalence and severity of urinary incontinence (UI) and fecal incontinence in morbidly obese women undergoing laparoscopic weight loss surgery. METHODS: In a prospective cohort study, 101 women (aged 20–55 years) with body mass index (BMI) of 40 or more underwent laparoscopic Roux-en-Y gastric bypass and were followed to 6 and 12 months. Presence, severity, and effect of UI were assessed using the Medical, Epidemiological, and Social Aspects of Aging Questionnaire, Urogenital Distress Inventory, and Incontinence Impact Questionnaire. Fecal incontinence was assessed by self-report of anal leakage. RESULTS: Mean BMI decreased from 48.9±7.2 presurgery to 35.3±6.5 at 6 months and 30.2±5.7 at 12 months postsurgery. Prevalence of UI decreased from 66.7% presurgery to 41.0% at 6 months and 37.0% at 12 months (P<.001; 95% confidence interval [CI] for change 18.6–40.0%). Reduction in prevalence of UI was significantly associated with decreases in BMI (P=.01). Among incontinent women who lost 18 or more BMI points, 71% regained urinary continence at 12 months. Medical, Epidemiological, and Social Aspects of Aging Questionnaire urge and stress scores decreased (both P<.001; 95% CI 0.5–1.85 and 2.71–5.34, respectively), as did scores on the Urogenital Distress Inventory (P<.001; 95% CI 8.31–16.21) and Incontinence Impact Questionnaire (P<.001; 95% CI 4.71–14.60), indicating reduction in severity. Prevalence of fecal incontinence (solid or liquid stool) decreased from 19.4% to 9.1% at 6 months and 8.6% at 12 months (P=.018; 95% CI 2.1–19.4%). CONCLUSION: Prevalence of UI and fecal incontinence decreased after bariatric surgery. Magnitude of weight loss was associated with reduction in UI prevalence, strengthening the inference that improvements are attributable to weight loss. LEVEL OF EVIDENCE: II

Comparison of 2 Transvaginal Surgical Approaches and Perioperative Behavioral Therapy for Apical Vaginal Prolapse: The OPTIMAL Randomized Trial

Objectives: To determine prevalence and correlates of fecal incontinence in older community‐dwelling adults.

Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: The OPTIMAL randomized trial

PURPOSE We tested the effectiveness of preoperative biofeedback assisted behavioral training for decreasing the duration and severity of incontinence, and improving quality of life in the 6 months following radical prostatectomy. MATERIALS AND METHODS We performed a prospective, randomized, controlled trial comparing preoperative behavioral training to usual care. The volunteer sample included 125 men 53 to 68 years old who elected radical prostatectomy for prostate cancer. Patients were stratified according to age and tumor differentiation, and randomized to 1 preoperative session of biofeedback assisted behavioral training plus daily home exercise or a usual care control condition, consisting of simple postoperative instructions to interrupt the urinary stream. The main outcome measurements were duration of incontinence (time to continence), as derived from bladder diaries, incontinence severity (the proportion with severe/continual leakage), pad use, Incontinence Impact Questionnaire, psychological distress (Hopkins Symptom Checklist) and health related quality of life (Medical Outcomes Study Short Form Health Survey). RESULTS Preoperative behavioral training significantly decreased time to continence (p = 0.03) and the proportion of patients with severe/continual leakage at the 6-month end point (5.9% vs 19.6%, p = 0.04). There were also significant differences between the groups for self-reported urine loss with coughing (22.0% vs 51.1%, p = 0.003), sneezing (26.0% vs 48.9%, p = 0.02) and getting up from lying down (14.0% vs 31.9%, p = 0.04). No differences were found on return to work and usual activities or quality of life measures. CONCLUSIONS Preoperative behavioral training can hasten the recovery of urine control and decrease the severity of incontinence following radical prostatectomy.

Urinary and anal incontinence in morbidly obese women considering weight loss surgery.

IMPORTANCE More than 300,000 surgeries are performed annually in the United States for pelvic organ prolapse. Sacrospinous ligament fixation (SSLF) and uterosacral ligament suspension (ULS) are commonly performed transvaginal surgeries to correct apical prolapse. Little is known about their comparative efficacy and safety, and it is unknown whether perioperative behavioral therapy with pelvic floor muscle training (BPMT) improves outcomes of prolapse surgery. OBJECTIVE To compare outcomes between (1) SSLF and ULS and (2) perioperative BPMT and usual care in women undergoing surgery for vaginal prolapse and stress urinary incontinence. DESIGN, SETTING, AND PARTICIPANTS Multicenter, 2 × 2 factorial, randomized trial of 374 women undergoing surgery to treat both apical vaginal prolapse and stress urinary incontinence was conducted between 2008 and 2013 at 9 US medical centers. Two-year follow-up rate was 84.5%. INTERVENTIONS The surgical intervention was transvaginal surgery including midurethral sling with randomization to SSLF (n = 186) or ULS (n = 188); the behavioral intervention was randomization to receive perioperative BPMT (n = 186) or usual care (n = 188). MAIN OUTCOMES AND MEASURES The primary outcome for the surgical intervention (surgical success) was defined as (1) no apical descent greater than one-third into vaginal canal or anterior or posterior vaginal wall beyond the hymen (anatomic success), (2) no bothersome vaginal bulge symptoms, and (3) no re-treatment for prolapse at 2 years. For the behavioral intervention, primary outcome at 6 months was urinary symptom scores (Urinary Distress Inventory; range 0-300, higher scores worse), and primary outcomes at 2 years were prolapse symptom scores (Pelvic Organ Prolapse Distress Inventory; range 0-300, higher scores worse) and anatomic success. RESULTS At 2 years, surgical group was not significantly associated with surgical success rates (ULS, 59.2% [93/157] vs SSLF, 60.5% [92/152]; unadjusted difference, -1.3%; 95% CI, -12.2% to 9.6%; adjusted odds ratio [OR], 0.9; 95% CI, 0.6 to 1.5) or serious adverse event rates (ULS, 16.5% [31/188] vs SSLF, 16.7% [31/186]; unadjusted difference, -0.2%; 95% CI, -7.7% to 7.4%; adjusted OR, 0.9; 95% CI, 0.5 to 1.6). Perioperative BPMT was not associated with greater improvements in urinary scores at 6 months (adjusted treatment difference, -6.7; 95% CI, -19.7 to 6.2), prolapse scores at 24 months (adjusted treatment difference, -8.0; 95% CI, -22.1 to 6.1), or anatomic success at 24 months. CONCLUSIONS AND RELEVANCE Two years after vaginal surgery for prolapse and stress urinary incontinence, neither ULS nor SSLF was significantly superior to the other for anatomic, functional, or adverse event outcomes. Perioperative BPMT did not improve urinary symptoms at 6 months or prolapse outcomes at 2 years. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00597935.