Comparing Vitamin D Supplementation Versus Placebo for Urgency Urinary Incontinence: A Pilot Study.

OBJECTIVES: To estimate the efficacy of vitamin D supplementation to reduce urgency urinary incontinence (UUI) episodes. DESIGN: Pilot, two-arm, randomized trial conducted from 2013 to 2017. Interventions were 12 weeks of weekly oral 50,000 IU vitamin D3 or placebo. SETTING: Academic, university-based outpatient clinic. PARTICIPANTS: Community-dwelling postmenopausal women, 50 years or older, with at least three UUI episodes on 7-day bladder diary and serum vitamin 25-hydroxyvitamin D (25[OH]D) of 30 ng/mL or less. MEASUREMENTS: The primary efficacy estimate was the percentage change in UUI episodes. Secondary estimates included changes in other lower urinary tract symptoms, along with exploratory subgroup analysis by race/ethnicity and obesity. RESULTS: We randomized 56 women (aged 50-84 years; mean = 60.5 ± 8.2 years), 28 to vitamin D and 28 to placebo; 51 completed treatments. Mean serum 25(OH)D at baseline (21.2 ± 5.2 and 18.2 ± 5.6, P = .30) improved to 57.9 ± 16.3 ng/mL with vitamin D3 and 21.9 ± 8.2 ng/mL with placebo (P < .001). UUI episodes per 24-hour day decreased by 43.0% with vitamin D3 compared to 27.6% with placebo (P = .22). Among black women (n = 33), UUI episodes decreased by 63.2% with vitamin D3 compared to 22.9% with placebo (P = .03). Among obese women, UUI episodes decreased by 54.1% with vitamin D compared to 32.7% with placebo (P = .29). For all women, changes in voiding frequency (P = .40), nocturia (P = .40), urgency (P = .90), incontinence severity (P = .81), and overactive bladder symptom severity (P = .47) were not different between arms. CONCLUSIONS: Postmenopausal women with UUI and vitamin D insufficiency demonstrated a greater than 40% decrease in UUI episodes, which did not reach statistical significance compared to placebo, except in the subset of black women. The results of this pilot study support further investigation of vitamin D3 alone or in combination with other treatments for UUI, particularly for women in higher-risk subgroups. J Am Geriatr Soc 67:570-575, 2019.

Loperamide Versus Psyllium Fiber for Treatment of Fecal Incontinence: The Fecal Incontinence Prescription (Rx) Management (FIRM) Randomized Clinical Trial.

BACKGROUND: Fecal incontinence is a devastating condition with few US Food and Drug Administration-approved pharmacologic treatment options. Loperamide and psyllium, both first-line treatments, have different mechanisms of action without any comparative data. OBJECTIVE: The purpose of this study was to examine the effectiveness and tolerability of loperamide compared with psyllium for reducing fecal incontinence. We hypothesized that psyllium fiber supplementation would be more effective than loperamide for reducing fecal incontinence episodes and have fewer adverse effects. DESIGN: We conducted a randomized, double-blind, placebo-controlled crossover trial comparing loperamide (followed by psyllium) with psyllium (followed by loperamide). SETTINGS: Our sites included outpatient clinics within a Veterans Affairs medical center and university affiliate. PATIENTS: Participants included community-dwelling adults (n = 80) with at least 1 fecal incontinent episode on a 7-day bowel diary. INTERVENTION: Participants received either daily loperamide (plus placebo psyllium powder) or psyllium powder (plus loperamide placebo) for 4 weeks. After a 2-week washout, participants crossed over to 4 weeks of alternate treatment. MAIN OUTCOME MEASURES: The primary outcome was the number of fecal incontinence episodes from 7-day bowel diaries. Secondary outcomes included symptom severity, quality of life, and tolerability. RESULTS: Mean age was 60.7 ± 10.1 years; 68% were men. After determining nonsignificant carryover effects, combined analyses showed no differences between the loperamide and psyllium groups for reducing fecal incontinent episodes, symptom severity, or quality of life. Within each group, both loperamide and psyllium reduced fecal incontinent episodes and improved symptom severity and quality of life. Constipation occurred in 29% of participants for loperamide vs 10% for psyllium. LIMITATIONS: Limitations include the washout period length and dropout rate after crossing over to the second intervention. CONCLUSIONS: Both loperamide and psyllium improve fecal incontinence. Loperamide was associated with more adverse effects, especially constipation.

Caffeine intake and its association with urinary incontinence in United States men: results from National Health and Nutrition Examination Surveys 2005-2006 and 2007-2008.

PURPOSE: Epidemiological studies in women have revealed an association between caffeine intake and urinary incontinence, although evidence among men is limited. Therefore, we evaluated the association between caffeine intake and urinary incontinence in United States men. MATERIALS AND METHODS: Data were used from male NHANES (National Health and Nutrition Examination Surveys) 2005-2006 and 2007-2008 participants. Urinary incontinence was defined using a standard questionnaire with Incontinence Severity Index scores 3 or greater categorized as moderate to severe. Structured dietary recall was used to determine caffeine consumption (mg per day), water intake (gm per day) and total dietary moisture (gm per day). Stepwise multivariable logistic regression models were used to assess the association between caffeine intake at or above the 75th and 90th percentiles and moderate to severe urinary incontinence, controlling for potential confounders, urinary incontinence risk factors and prostate conditions in men age 40 years or older. RESULTS: Of the 5,297 men 3,960 (75%) were 20 years old or older with complete data. Among these men the prevalence of any urinary incontinence was 12.9% and moderate to severe urinary incontinence was 4.4%. Mean caffeine intake was 169 mg per day. Caffeine intake at the upper 75th percentile (234 mg or more daily) and 90th percentile (392 mg or more per day) was significantly associated with having moderate to severe urinary incontinence (1.72, 95% 1.18-2.49 and 2.08, 95% 1.15-3.77, respectively). In addition, after adjusting for prostate conditions, the effect size for the association between caffeine intake and moderate to severe urinary incontinence remained. CONCLUSIONS: Caffeine consumption equivalent to approximately 2 cups of coffee daily (250 mg) is significantly associated with moderate to severe urinary incontinence in United States men. Our findings support the further study of caffeine modification in men with urinary incontinence.

Behavioral therapy with or without biofeedback and pelvic floor electrical stimulation for persistent postprostatectomy incontinence: a randomized controlled trial.

CONTEXT: Although behavioral therapy has been shown to improve postoperative recovery of continence, there have been no controlled trials of behavioral therapy for postprostatectomy incontinence persisting more than 1 year. OBJECTIVE: To evaluate the effectiveness of behavioral therapy for reducing persistent postprostatectomy incontinence and to determine whether the technologies of biofeedback and pelvic floor electrical stimulation enhance the effectiveness of behavioral therapy. DESIGN, SETTING, AND PARTICIPANTS: A prospective randomized controlled trial involving 208 community-dwelling men aged 51 through 84 years with incontinence persisting 1 to 17 years after radical prostatectomy was conducted at a university and 2 Veterans Affairs continence clinics (2003-2008) and included a 1-year follow-up after active treatment. Twenty-four percent of the men were African American; 75%, white. INTERVENTIONS: After stratification by type and frequency of incontinence, participants were randomized to 1 of 3 groups: 8 weeks of behavioral therapy (pelvic floor muscle training and bladder control strategies); behavioral therapy plus in-office, dual-channel electromyograph biofeedback and daily home pelvic floor electrical stimulation at 20 Hz, current up to 100 mA (behavior plus); or delayed treatment, which served as the control group. MAIN OUTCOME MEASURE: Percentage reduction in mean number of incontinence episodes after 8 weeks of treatment as documented in 7-day bladder diaries. RESULTS: Mean incontinence episodes decreased from 28 to 13 per week (55% reduction; 95% confidence interval [CI], 44%-66%) after behavioral therapy and from 26 to 12 (51% reduction; 95% CI, 37%-65%) after behavior plus therapy. Both reductions were significantly greater than the reduction from 25 to 21 (24% reduction; 95% CI, 10%-39%) observed among controls (P = .001 for both treatment groups). However, there was no significant difference in incontinence reduction between the treatment groups (P = .69). Improvements were durable to 12 months in the active treatment groups: 50% reduction (95% CI, 39.8%-61.1%; 13.5 episodes per week) in the behavioral group and 59% reduction (95% CI, 45.0%-73.1%; 9.1 episodes per week) in the behavior plus group (P = .32). CONCLUSIONS: Among patients with postprostatectomy incontinence for at least 1 year, 8 weeks of behavioral therapy, compared with a delayed-treatment control, resulted in fewer incontinence episodes. The addition of biofeedback and pelvic floor electrical stimulation did not result in greater effectiveness. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00212264.

Preoperative biofeedback assisted behavioral training to decrease post-prostatectomy incontinence: a randomized, controlled 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.

Effects of behavioral and drug therapy on nocturia in older incontinent women.

OBJECTIVES: To examine changes in nocturia from a multicomponent behavioral training program or drug therapy in older women with urge or mixed (urge-predominant) urinary incontinence. DESIGN: A secondary analysis of data from a prospective, randomized clinical trial. SETTING: Parent trial was an outpatient research protocol in Alabama. PARTICIPANTS: One hundred ninety-seven women (aged 55-92) with incontinence and urodynamic evidence of bladder dysfunction. At baseline, 131 women (66% of participants) had nocturia. INTERVENTION: In the parent study, participants received behavioral training, including four sessions of biofeedback-assisted pelvic floor muscle exercises, drug treatment (oxybutynin IR titrated from 2.5 mg per day to 5.0 mg three times a day), or placebo. MEASUREMENTS: Participant-completed bladder diaries were used to calculate changes in nocturia. RESULTS: Behavioral training reduced nocturia by a median 0.50 episodes per night and was significantly more effective than drug treatment (median reduction=0.30 episodes; P=.02) and placebo (median reduction=0.00 episodes; P<.001). Also, drug treatment was more effective than control (P=.007). CONCLUSION: Both behavioral training and drug treatment reduced nocturia more than placebo, but behavioral training was the most effective.

Behavioral and drug therapy for urinary incontinence.

In a randomized, controlled trial comparing biofeedback-assisted behavioral therapy and drug therapy with oxybutynin, both types of therapy were superior to placebo in older, community-dwelling women with urge or mixed incontinence. Behavioral therapy significantly reduced incontinence compared with oxybutynin therapy (80.7% vs 68.5%, P = 0.04). Patients expressed high levels of satisfaction with behavioral therapy, and 97% were willing to continue this therapy indefinitely, compared with 55% receiving drug therapy. Results of recent studies suggest that behavioral therapy without biofeedback or pelvic floor electrical stimulation also results in significant clinical benefits, which should make behavioral therapy a more practical approach in the general practice setting. Statistical analysis showed no significant relationship between posttreatment urodynamic changes and clinical outcomes, and thus, the mechanisms by which behavioral and drug therapies work remain unidentified. In a small trial of combination therapy, patients who received both drug and behavioral therapy experienced significant clinical improvements compared with the effects of monotherapy with either treatment.

Effect of behavioral training with or without pelvic floor electrical stimulation on stress incontinence in women: a randomized controlled trial.

CONTEXT: Pelvic floor electrical stimulation (PFES) has been shown to be effective for stress incontinence. However, its role in a multicomponent behavioral training program has not been defined. OBJECTIVE: To determine if PFES increases efficacy of behavioral training for community-dwelling women with stress incontinence. DESIGN AND SETTING: Prospective randomized controlled trial conducted from October 1, 1995, through May 1, 2001, at a university-based outpatient continence clinic in the United States. PATIENTS: Volunteer sample of 200 ambulatory, nondemented, community-dwelling women aged 40 to 78 years with stress or mixed incontinence with stress as the predominant pattern; stratified by race, type of incontinence (stress only vs mixed), and severity (frequency of episodes). INTERVENTIONS: Patients were randomly assigned to 8 weeks (4 visits) of behavioral training, 8 weeks (4 visits) of the behavioral training plus home PFES, or 8 weeks of self-administered behavioral treatment using a self-help booklet (control condition). MAIN OUTCOME MEASURES: Primary outcome was percentage reduction in the number of incontinent episodes as documented in bladder diaries. Secondary outcomes were patient satisfaction and changes in quality of life. RESULTS: Intention-to-treat analysis showed that incontinence was reduced a mean of 68.6% with behavioral training, 71.9% with behavioral training plus PFES, and 52.5% with the self-help booklet (P =.005). In comparison with the self-help booklet, behavioral training (P =.02) and behavioral training plus PFES (P =.002) were significantly more effective, but they were not significantly different from each other (P =.60). The PFES group had significantly better patient self-perception of outcome (P<.001) and satisfaction with progress (P =.02). Significant improvements were seen across all 3 groups on the Incontinence Impact Questionnaire but with no between-group differences. CONCLUSIONS: Treatment with PFES did not increase effectiveness of a comprehensive behavioral program for women with stress incontinence. A self-help booklet reduced incontinence and improved quality of life but not as much as the clinic-based programs.

Behavioral training with and without biofeedback in the treatment of urge incontinence in older women: a randomized controlled trial.

CONTEXT: Previous research on urge urinary incontinence has demonstrated that multicomponent behavioral training with biofeedback is safe and effective, yet it has not been established whether biofeedback is an essential component that heightens therapeutic efficacy. OBJECTIVE: To examine the role of biofeedback in a multicomponent behavioral training program for urge incontinence in community-dwelling older women. DESIGN: Prospective, randomized controlled trial conducted from April 1, 1995, to March 30, 2001. SETTING: University-based outpatient continence clinic in the United States. PATIENTS: A volunteer sample of 222 ambulatory, nondemented, community-dwelling women aged 55 to 92 years with urge incontinence or mixed incontinence with urge as the predominant pattern. Patients were stratified by race, type of incontinence (urge only vs mixed), and severity (frequency of accidents). INTERVENTIONS: Patients were randomly assigned to receive 8 weeks (4 visits) of biofeedback-assisted behavioral training (n = 73), 8 weeks (4 visits) of behavioral training without biofeedback (verbal feedback based on vaginal palpation; n = 74), or 8 weeks of self-administered behavioral treatment using a self-help booklet (control condition; n = 75). MAIN OUTCOME MEASURES: Reduction in the number of incontinence episodes as documented in bladder diaries, patients' perceptions and satisfaction, and changes in quality of life. RESULTS: Intention-to-treat analysis showed that behavioral training with biofeedback yielded a mean 63.1% reduction (SD, 42.7%) in incontinence, verbal feedback a mean 69.4% reduction (SD, 32.7%), and the self-help booklet a mean 58.6% reduction (SD, 38.8%). The 3 groups were not significantly different from each other (P =.23). The groups differed significantly regarding patient satisfaction: 75.0% of the biofeedback group, 85.5% of the verbal feedback group, and 55.7% of the self-help booklet group reported being completely satisfied with treatment (P =.001). Significant improvements were seen across all 3 groups on 3 quality-of-life instruments, with no significant between-group differences. CONCLUSIONS: Biofeedback to teach pelvic floor muscle control, verbal feedback based on vaginal palpation, and a self-help booklet in a first-line behavioral training program all achieved comparable improvements in urge incontinence in community-dwelling older women. Patients' perceptions of treatment were significantly better for the 2 behavioral training interventions.