Investigation of nursing students' knowledge levels and attitudes in incontinence-associated dermatitis management through game-based learning: a mixed methods study.

PURPOSE: This study aimed to assess nursing students' knowledge levels and attitudes towards the etiology, risk factors, and preventive measures of incontinence-associated dermatitis (IAD) using an escape room game. DESIGN: A mixed-method study. SUBJECTS AND SETTING: The sample size of the study was 32 students. METHODS: Quantitative data obtained with the Knowledge, Attitude and Practice of Nurses in Managing Incontinence-Associated Dermatitis Questionnaire (KAP-IAD-Q) and qualitative data obtained through FGDs following the Consolidated Criteria for Reporting Qualitative Research (COREQ) checklist were analyzed using a thematic approach. RESULTS: The average age of the participants was 22.63 ± 0.90, 87.5% of them were female (n=28), and 50% were third (n=16) and fourth-year students (n=16). KAP-IAD-Q total posttest score (88.06+7.00) was found to be high. Data obtained from the FGDs were categorized under 3 main themes: main focus areas during participation in the IAD-themed escape room game; advantages and disadvantages of teamwork in IAD management; and the game's contribution to a better understanding and classification of IAD. CONCLUSIONS: The use of the escape room game facilitated high, fast, and efficient learning of IAD knowledge and attitudes. It revealed challenges in collaborative decision-making, accurate diagnosis, distinguishing from other wounds, and attitude development in the management of IAD.

Prognostic factors for the development of incontinence-associated dermatitis (IAD): A systematic review.

Incontinence-associated dermatitis (IAD) is an irritant contact dermatitis from prolonged contact with urine or faeces, which can significantly impact patient comfort and quality of life. The identification of prognostic factors for the development of IAD has the potential to enhance management, support preventive measures and guide future research. The objective of this systematic review was to summarize the empirical evidence of prognostic factors for the development of IAD. This study included prospective and retrospective observational studies or clinical trials that described prognostic factors associated with IAD. There were no restrictions on setting, time, language, participants or geographical regions. Exclusion criteria included reviews, editorials, commentaries, methodological articles, letters to the editor, cross-sectional and case-control studies, and case reports. Searches were conducted from inception to April 2024 on MEDLINE, CINAHL, EMBASE and the Cochrane Library. The studies were assessed by two independent reviewers using the QUIPS and the CHARMS-PF for data extraction. A narrative synthesis approach was employed due to study heterogeneity and using the 'vote counting based on direction' method and the sign test. The overall certainty of evidence was assessed using adapted GRADE criteria. The review included 12 studies and identified 15 potential predictors. Moderate-quality evidence suggests that increased stool frequency, limited mobility and friction/shear problems are risk factors for IAD development. Female sex, older age, vasopressor use and loose/liquid stool are risk factors supported by low-quality evidence. Increased stool frequency, limited mobility and friction/shear problems seem to be risk factors for the development of IAD. There is insufficient evidence to support the predictive validity of female sex, older age, loose/liquid stool and vasopressor use. There is substantial methodological variability across studies, making it challenging to make comparisons. Large-scale cohort studies in different settings that incorporate our review findings should be conducted in the future.

Risk Factors for Incontinence-Associated Dermatitis in Critically Ill Patients with Incontinence: A Systematic Review and Meta-analysis.

PURPOSE: This systematic review analyzed evidence related to risk factors for Incontinence Associated Dermatitis (IAD) in critically ill incontinent patients. METHOD: Systematic review and meta-analysis. SEARCH STRATEGY: Eight databases, including PubMed, Embase, CINAHL, Cochrane Library, and Web of Science, were searched for studies published in the English language. The China National Knowledge Infrastructure, WanFang Data, and Chinese Scientific Journal Database were also searched for studies evaluating risk of IAD in critically ill incontinent patients published in the Chinese language. FINDINGS: Twenty-four studies with moderate-to-high methodological quality were included. Significant risk factors for developing IAD were being older [odds ratio (OR) = 1.06, 95% confidence interval (CI): 1.02-1.10, P = .007], fever (OR = 2.57, 95% CI: 1.87-3.57, P < .00001), diagnosed with consciousness disorder (OR = 5.70, 95% CI: 2.28-14.22, P = .0002), having higher Acute Physiology and Chronic Health Evaluation (APACHE) II score (OR = 1.71, 95% CI: 1.25-2.35, P = .0009), lower Braden score (OR = 0.73, 95% CI: 0.56-0.96, P = .02), lower oxygen saturation (OR = 2.76, 95% CI: 1.52-5.00, P = .0008), double incontinence (OR = 4.10, 95% CI: 2.34-7.17, P < .00001), liquid stool (OR = 6.55, 95% CI: 4.12-10.41, P < .00001), frequent incontinence (OR = 1.21, 95% CI: 1.03-1.43, P = .02), and higher perineal assessment tool (PAT) score (OR = 3.18, 95% CI: 1.76-5.76, P = .0001). IMPLICATIONS: Findings of this systematic review and meta-analysis suggest that healthcare providers should consider risk factors such as older age, fever, consciousness disorder, higher APACHE II score, lower Braden score and double incontinence matter when developing strategies for the prevention and management of IAD in critically ill incontinent patients.

Incidence of incontinence-associated dermatitis in hospitalised neonates. Adaptation and validation of a severity scale.

INTRODUCTION: Up to 60% of hospitalised neonates may develop incontinence-associated dermatitis (IAD). Our aim was to adapt the Clinical Evaluation Scale for Characterization of the Severity of Diaper Dermatitis to the Spanish population and to find out the nationwide frequency of IAD in hospitalized neonates. METHODS: Cross-cultural adaptation and assessment of content validity of the scale. We carried out a prospective, multicentre observational study of the incidence of nappy rash in postnatal wards and neonatal intensive care units in 6 Spanish hospitals. RESULTS: We obtained a content validity index of 0.869 for the total scale (95% CI, 0.742-0.939). The sample included 196 neonates. The cumulative incidence of IAD was 32.1% (9.1% mild-moderate, 8% moderate and 1.6% severe). The incidence rate was 2.2 IAD cases per 100 patient days. A stool pH of less than 5.5, a greater number of bowel movements a day, a greater daily urine output and the use of oral drugs were among the factors associated with the development of IAD. CONCLUSION: The Spanish version of the Clinical Evaluation Scale for Characterization of the Severity of Diaper Dermatitis had an adequate content validity for the assessment of DAI in the hospitalised neonatal population. Mixed feeding, treatment with oral drugs and the use of medical devices in the perianal area were associated with an increased risk of nappy dermatitis in infants.

Impact of an evidence-based bundle on incontinence-associated dermatitis prevalence in hospital patients: A quasi-experimental translational study.

The study aimed to evaluate the effect of an intervention on the prevalence and severity of incontinence-associated dermatitis (IAD) in six hospitals in one state in Australia. This quasi-experimental pre-and post-study, conducted in 18 wards, was part of a larger implementation science study on incontinence-associated dermatitis. Skin and incontinence assessments were conducted on patients during February and March 2020 (pre-intervention) and July and August 2021 (post-intervention). The intervention comprised continence assessment and management, an education brochure for patients, family and caregivers on IAD, the Ghent Global IAD Categorisation Tool (GLOBIAD) and a skin care regime with patient skin protection measures (three-in-one barrier cream cloths, minimisation of bed protection layers, use of appropriate continence aid). A total of 1897 patients were assessed (pre-intervention = 964, post-intervention = 933). A total of 343 (35.6%) pre-intervention patients and 351 (37.6%) post-intervention patients had incontinence. The prevalence of hospital-acquired IAD was 6.71% in the pre-intervention group and 4.27% in the post-intervention group; a reduction of 36.3% (p = 0.159) despite higher patient acuity, prevalence of double incontinence and the COVID-19 pandemic in the post-intervention group compared with the pre-intervention group. Our multisite best practice IAD prevention and treatment intervention was able to reduce the prevalence and severity of hospital-acquired IAD, suggesting enduring effectiveness of the intervention.

Is the varying management of incontinence-associated dermatitis due to a lack of understanding of etiology?

Incontinence-associated dermatitis, previously and sometimes still referred to as moisture lesions or moisture damage, is a commonly seen contact dermatitis that is a reactive response of the skin to chronic contact to urine and faecal matter. Understanding the etiology is fundamental to creating a skin care plan and successfully prevention. Systemic reviews and studies have shown that the continued variability in management results from a combination of knowledge base, observation, diagnosis, and product selection. This article aims to improve clinicians' understanding of incontinence-associated dermatitis and its management.

Incontinence-associated dermatitis in older adults in residential care settings: a point prevalence study.

Incontinence-associated dermatitis (IAD) is a skin inflammation caused by contact with urine or faeces or both. It has a negative effect on the patient's quality of life and is indicative of the care provided. However, globally there is a lack of empirical data on the prevalence of IAD. AIM: To identify, for the first time, the proportion of older adults in extended care settings in Ireland affected by IAD. DESIGN: Cross-sectional, multisite, point prevalence survey, across three community extended care settings for older people in Ireland. METHODS: Two clinical nurse specialists, using the Scottish Excoriation and Moisture Related Skin Damage Tool, identified the presence of IAD through clinical observation and visual skin inspection. IAD prevalence was calculated for the total population and incontinent population sets using percentages and confidence intervals (CI). RESULTS: The prevalence of incontinence was 86.4% (n=165), a significantly higher proportion were female (P=0.003). The point prevalence of IAD across the total population and incontinent population was 11.5% (22/191; 95% CI, 7.4-19.9%) and 13.3% (22/164; 95% CI, 8.5-19.5%), respectively. Being incontinent was associated with being female, more dependent (Barthel), having possible cognitive impairment, poorer mobility (Braden and Waterlow) and a high risk of pressure ulcers (Waterlow). A logistic regression analysis found no predictor variables for IAD among the variables that met the cut-off point for this analysis. CONCLUSIONS: The study provides the first point prevalence empirical data on the occurrence of IAD in Ireland. It can inform decision-making on future planning and budgeting of new quality improvement projects and act as a benchmark for ongoing auditing of IAD.

Incontinence in people living with dementia.

Dementia and incontinence are both prevalent in older age; yet, neither are an inevitable or normal part of ageing. It has been recognised that there is a skills and knowledge gap in professionals assessing and managing incontinence for people living with dementia. All too often, assumptions are made that incontinence is a symptom of dementia and that nothing can be done if a person living with dementia experiences episodes of incontinence. While dementia may impact on a person's ability to remain continent, it may not be the sole cause, and there may be treatments and strategies that can reduce the incidence in those affected. Therefore, a person-centred continence assessment should be undertaken to promote continence and reduce the impact of incontinence for people living with dementia and those who care for them. This paper will highlight some of the issues that are important for health and social care professionals to explore and identify, assess and manage incontinence to improve outcomes for families affected by dementia.

Managing incontinence-associated dermatitis in the community: an overview.

Incontinence-associated dermatitis (IAD) is often treated a hygienic challenge, rather than a serious condition with potentially life-threatening consequences. More appropriate education on the management strategies specific to IAD is required, in order for personalised and effective care that reflects the critical nature of this condition to be provided. Francesca Ramadan provides an overview of the key elements of best practice in IAD management and treatment.

Factors affecting the development of incontinence dermatitis among patients in intensive care unit.

AIM: This research was conducted to determine the factors affecting the development of incontinence-associated dermatitis in intensive care patients. METHODS: The sample of the study consisted of 114 intensive care patients who developed incontinence-associated dermatitis. Patients were followed for a minimum of 8 days. The 'Patient Information Form' and the 'Incontinence-Associated Dermatitis and Severity Instrument (IADSI)' were used for data collection. The data were collected between February and May 2022. Ethics committee approval was obtained for the research. In the evaluation of the data, SPSS for Windows (Version 24.0, Statistical Package for Social Sciences) program was used. RESULTS: It was determined that there was a statistically significant difference in the mean IADSI score between day 1 (17.79 ± 6.06) and day 8 (27.35 ± 9.55). Statistically significant differences were found between mean IADSI score and gender, status of smoking and alcohol use, chronic disease status, regular medication use, type and level of nutrition, defecation characteristics and number, presence of infection, presence of urinary and fecal incontinence, mobility and sweating status, body and defecation hygiene, age and BMI (p < 0.05). CONCLUSION: The day 8 IADSI scores are considered to be evidence of the rapid progress of IAD after its development. It is important to know the risk factors associated with IAD in order to recognize the risk factors before IAD develops and to take possible precautions for these risk factors.

Evaluation of functional gastrointestinal disorders in children aged 4-10 years with autism spectrum disorder.

BACKGROUND: Gastrointestinal system disorders are known to be prevalent among children with autism spectrum disorder (ASD). Some ASD-associated comorbidities are abdominal pain, constipation, diarrhea, gastroesophageal reflux, sleep disturbances, epilepsy, and psychiatric problems. Nonetheless, there is still limited information about the presence of functional GI disorders (FGIDs) among children with ASD, especially in Türkiye. Using the Rome criteria, we aimed to investigate FGIDs in children with ASD. METHODS: The sample of the study consisted of 68 children aged 4-10 years, diagnosed with ASD according to the DSM-5 diagnostic criteria and had scores greater than 30 on the Childhood Autism Rating Scale (CARS-2) and an age-sex matched control group (n=78). The Rome III criteria were used to evaluate FGIDs. RESULTS: The frequency of FGIDs in the ASD group was higher (76.5%) compared to the control group (p < 0.001). Compared to the control group, abdominal migraine frequency increased 10 times (p=0.012), functional constipation 7 times (p < 0.001), and fecal incontinence 6 times (p < 0.001) in the ASD group. Stool retention was not present in most children in the ASD group who were found to have fecal incontinence. CONCLUSION: In this study, the most common FGIDs in the ASD group were abdominal migraine, functional constipation, and non-retentive fecal incontinence. The finding that most children with ASD who had fecal incontinence did not show stool retention implicated social, psychological, and behavioral factors as the causes of incontinence. Raising awareness of healthcare professionals about the frequency of FGIDs in children with ASD will improve many areas in the daily lives of these children.

Primary care providers practice patterns regarding female pelvic floor disorders.

INTRODUCTION: Pelvic floor disorders (PFDs) pose substantial physical and psychological burdens for a growing number of women. Given the ubiquity of these conditions and known patient reluctance to seek care, primary care providers (PCPs) have a unique opportunity to increase treatment and provide appropriate referrals for these patients. METHODS: An online survey was administered to PCPs to assess provider practices, knowledge, comfort managing and ease of referral for PFDs. Logistic regression was used to assess the association between demographic/practice characteristics of PCPs and two primary outcomes of interest: discomfort with management and difficulty with referral of PFDs. RESULTS: Of the 153 respondents to the survey, more felt comfortable managing stress urinary incontinence (SUI) and overactive bladder (OAB), compared with pelvic organ prolapse (POP) and faecal incontinence (FI) and were less likely to refer patients with urinary symptoms. Few providers elicited symptoms for POP and FI as compared with SUI and OAB. Provider variables that were significantly associated with discomfort with management varied by PFD, but tended to correlate with less exposure to PFDs (eg, those with fewer years of practice, and internal medicine and family physicians as compared with geriatricians); whereas the factors that were significantly associated with difficulty in referral, again varied by PFD, but were related to practice characteristics (eg, specialist network, type of practice, practice setting and quantity of patients). CONCLUSION: These findings highlight the need to increase PCPs awareness of PFDs and develop effective standardised screening protocols, as well as collaboration with pelvic floor specialists to improve screening, treatment and referral for patients with PFDs.

Urinary and Fecal Incontinence During Sexual Activity Is Common and Bothersome Among Adults With Spina Bifida.

OBJECTIVE: To evaluate the prevalence of and risk factors for urinary fecal incontinence (UI, FI) during sexual activity (UIS, FIS) among adults with spina bifida (SB). METHODS: An international online survey of adults with SB was administered through SB clinics and SB organizations via social media. Adults with a history of masturbation or partnered sexual activity were included. The primary outcome was ever experiencing UIS/FIS. Nonparametric tests and logistic regression were used for analysis. RESULTS: A total of 341 adults met inclusion criteria (median age: 36years, 59% female, 52% shunted, 48% community ambulators). Baseline UI in the last 4weeks was reported by 50% and FI by 41%. Nineteen (5%) had a urostomy. Eight (2%) had a colostomy. Overall, 93% had a history of partnered genital contact. Among adults without a diversion, UIS was more common than FIS (70% vs 45%, P < .001). Among adults without a urostomy, UIS was more common among women (76% vs 62%, P = .01) and those with baseline UI (84% vs 50%, P < .001). UIS was not associated with age, shunt, ambulatory, or catheterization status (P >=.32). On bivariate analysis, female sex and baseline UI were independent predictors of UIS (P <=.001). Among adults without a colostomy, FIS was associated with female sex (50% vs 39%, P = .046), baseline FI (59% vs 32%, P < .001), community ambulation (52% vs 40%, P = .04), but not age, shunt, or MACE status (P >=.27). On multivariate analysis, baseline FI was independently associated with FIS (P < .001). Among adults with UIS/FIS, 29% experienced UIS "almost always" to "always," compared to 5% for FIS (P < .001). Virtually all adults found UIS/FIS bothersome (>=96% for each), even when incontinence occurred "almost never." UIS/FIS mostly occurred before and/or during orgasm than afterward (P < .001). UIS was reported by 53% of adults with a urostomy (100% bothersome). FIS was reported by 38% of adults with a colostomy (100% bothersome). CONCLUSION: Incontinence during sexual activity is a common problem for men and women with SB. Baseline incontinence is an independent, but not absolute, predictor of both. While FIS is less frequent than UIS, both are virtually always bothersome.

The association between vitamin-D deficiency and fecal incontinence.

BACKGROUND: Vitamin-D is essential for musculoskeletal health. We aimed to determine whether patients with fecal incontinence (FI): (1) are more likely to have vitamin-D deficiency and, (2) have higher rates of comorbid medical conditions. METHODS: We examined 18- to 90-year-old subjects who had 25-hydroxy vitamin-D levels, and no vitamin-D supplementation within 3 months of testing, in a large, single-institutional electronic health records dataset, between 2017 and 2022. Cox proportional hazards survival analysis was used to assess association of vitamin-D deficiency on FI. KEY RESULTS: Of 100,111 unique individuals tested for serum 25-hydroxy vitamin-D, 1205 (1.2%) had an established diagnosis of FI. Most patients with FI were female (75.9% vs. 68.7%, p = 0.0255), Caucasian (66.3% vs. 52%, p = 0.0001), and older (64.2 vs. 53.8, p < 0.0001). Smoking (6.56% vs. 2.64%, p = 0.0001) and GI comorbidities, including constipation (44.9% vs. 9.17%, p = 0.0001), irritable bowel syndrome (20.91% vs. 3.72%, p = 0.0001), and diarrhea (28.55% vs. 5.2%, p = 0.0001) were more common among FI patients. Charlson Comorbidity Index score was significantly higher in patients with FI (5.5 vs. 2.7, p < 0.0001). Significantly higher proportions of patients with FI had vitamin-D deficiency (7.14% vs. 4.45%, p < 0.0001). Moreover, after propensity-score matching, rate of new FI diagnosis was higher in patients with vitamin-D deficiency; HR 1.9 (95% CI [1.14-3.15]), p = 0.0131. CONCLUSION & INFERENCES: Patients with FI had higher rates of vitamin-D deficiency along with increased overall morbidity. Future research is needed to determine whether increased rate of FI in patients with vitamin-D deficiency is related to frailty associated with increased medical morbidities.

Mental health disorders as a risk factor in young patients with rectal prolapse.

BACKGROUND: Rectal prolapse (RP) typically presents in the elderly, though it can present in younger patients lacking traditional risk factors. The current study compares medical and mental health history, presentation, and outcomes for young and older patients with RP. METHODS: This is a single-center retrospective review of patients who underwent abdominal repair of RP between 2005 and 2019. Individuals were dichotomized into two groups based on age greater or less than 40 years. RESULTS: Of 156 patients, 25 were < 40. Younger patients had higher rates of diagnosed mental health disorders (80% vs 41%, p < 0.001), more likely to take SSRIs (p = .02), SNRIs (p = .021), anxiolytics (p = 0.033), and antipsychotics (p < 0.001). Younger patients had lower preoperative incontinence but higher constipation. Both groups had low rates of recurrence (9.1% vs 11.6%, p = 0.73). CONCLUSIONS: Young patients with RP present with higher concomitant mental health diagnoses and represent unique risk factors characterized by chronic straining compared to pelvic floor laxity.

Correlation Between Mobile-Application Electronic Bowel Diary and Validated Questionnaires in Women with Fecal Incontinence.

INTRODUCTION AND HYPOTHESIS: Despite growing interest in a mobile-app bowel diary to assess fecal incontinence (FI) symptoms, data are limited regarding the correlation between mobile-app diary and questionnaire-based outcomes. The primary aim is to determine whether percentage reduction in FI episodes (FIEs)/week recorded on a mobile-app diary correlates with changes in scores of validated FI-symptom measures from baseline to 12 weeks in women with FI undergoing percutaneous tibial nerve stimulation (PTNS) versus sham. METHODS: This is a planned secondary analysis of a multicenter randomized trial in which women with FI underwent PTNS or sham. FIEs were collected using a mobile-app diary at baseline and after 12 weekly sessions. FI-symptom-validated measures included St. Mark's, Accidental Bowel Leakage Evaluation, FI Severity Index (FISI), Colorectal Anal Distress Inventory, Colorectal Anal Impact Questionnaire, FI Quality of Life, Patient Global Impression of Improvement (PGI-I), and Patient Global Symptom Control (PGSC) rating. Spearman's correlation coefficient (ρ) was computed between %-reduction in FIEs/week and change in questionnaire scores from baseline to 12 weeks. Significance was set at 0.005 to account for multiple comparisons. RESULTS: Baseline characteristics of 163 women (109 PTNS, 54 sham) include mean age 63.4±11.6, 81% white, body mass index 29.4±6.6 kg/m2, 4% previous FI surgeries, 6.6±5.5 FIEs/week, and St. Mark's score 17.4±2.6. A significant correlation was demonstrated between %-reduction in FIEs/week and all questionnaires (p<0.005). A moderate-strength correlation (|ρ|>0.4) was observed for St. Mark's (ρ=0.48), FISI (ρ=0.46), PGI-I (ρ=0.51), and PGSC (ρ=-0.43). CONCLUSIONS: In women with FI randomized to PTNS versus sham, a moderate correlation was noted between FIEs measured via mobile-app diary and FI-symptom-validated questionnaire scores.

Does Length of Extended Resection Beyond Transition Zone Change Clinical Outcome for Hirschsprung Pull-Through?

INTRODUCTION: A proximal resection margin greater than 5 cm from the intra-operative histologically determined transition zone has been deemed necessary to minimize the risk of transition zone pull-through. This extended resection may require the sacrifice of vascular supply and even further bowel resection. The impact of extended proximal resection margin on post-operative complications and functional outcomes is unclear. METHODS: A retrospective chart review of patients who underwent primary pull-through for Hirschsprung disease at a single institution between January 2008 and December 2022 was performed. An adequate proximal margin was defined by a circumferential normally ganglionated ring and absence of hypertrophic nerves. The extended margin was defined as the total length of proximal colon with normal ganglion cells and without hypertrophic nerves. Fecal incontinence severity was assessed with the Pediatric Fecal Incontinence Severity Score (PFISS). RESULTS: Eighty seven patients met criteria for inclusion. Median age at primary pull-through was 17 days (IQR 10-92 days), 55% (n = 48) of patients had an extended proximal margin (EPM) ≤ 5 cm, and 45% (n = 39) had an EPM > 5 cm. An EPM ≤5 cm was not associated with increased rates of Hirschsprung associated enterocolitis (≤5 cm 43%, >5 cm 39%, P = 0.701), diversion post pull-through (≤5 cm 10%, >5 cm 5%, P = 0.367) or reoperation for transition zone pull-through (≤5 cm 3%, >5 cm 0%, P = 0.112). EPM ≤5 cm had more frequent involuntary daytime bowel movements (P = 0.041) and more frequent voluntary bowel movements (P = 0.035). There were no differences in other measures of fecal incontinence severity. CONCLUSIONS: Shorter proximal extended margins beyond the adequate ganglionated margin do not significantly impact post-operative complication rates and have an unclear effect on fecal incontinence. TYPE OF STUDY: Case Control. LEVEL OF EVIDENCE: Level III.

A randomized double-blind trial of clonidine and colesevelam for women with fecal incontinence.

BACKGROUND: Diarrhea and rectal urgency are risk factors for fecal incontinence (FI). The effectiveness of bowel modifiers for improving FI is unclear. METHODS: In this double-blind, parallel-group, randomized trial, women with urge FI were randomly assigned in a 1:1 ratio to a combination of oral clonidine (0.1 mg twice daily) with colesevelam (1875 mg twice daily) or two inert tablets for 4 weeks. The primary outcome was a ≥50% decrease in number of weekly FI episodes. KEY RESULTS: Fifty-six participants were randomly assigned to clonidine-colesevelam (n = 24) or placebo (n = 32); 51 (91%) completed 4 weeks of treatment. At baseline, participants had a mean (SD) of 7.5 (8.2) FI episodes weekly. The primary outcome was met for 13 of 24 participants (54%) treated with clonidine-colesevelam versus 17 of 32 (53%) treated with placebo (p = 0.85). The Bristol stool form score decreased significantly, reflecting more formed stools with clonidine-colesevelam treatment (mean [SD], 4.5 [1.5] to 3.2 [1.5]; p = 0.02) but not with placebo (4.2 [1.9] to 4.1 [1.9]; p = 0.47). The proportion of FI episodes for semiformed stools decreased significantly from a mean (SD) of 76% (8%) to 61% (10%) in the clonidine-colesevelam group (p = 0.007) but not the placebo group (61% [8%] to 67% [8%]; p = 0.76). However, these treatment effects did not differ significantly between groups. Overall, clonidine-colesevelam was well tolerated. CONCLUSIONS AND INFERENCES: Compared with placebo, clonidine-colesevelam did not significantly improve FI despite being associated with more formed stools and fewer FI episodes for semiformed stools.