Dan M Livovsky1,2, Benjamin Koslowsky3, Eran Goldin3, Joseph Lysy3,4. 1. Digestive Diseases Institute, Shaare Zedek Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel. danlivo@yahoo.com. 2. The Neurogastroenterology and Pelvic Floor Unit, Digestive Diseases Institute, Shaare Zedek Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Israel, 12 Baiyt St., Jerusalem, Israel. danlivo@yahoo.com. 3. Digestive Diseases Institute, Shaare Zedek Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel. 4. The Neurogastroenterology and Pelvic Floor Unit, Digestive Diseases Institute, Shaare Zedek Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Israel, 12 Baiyt St., Jerusalem, Israel.
Abstract
INTRODUCTION AND HYPOTHESIS: Fecal incontinence is a debilitating condition with a devastating impact on quality of life. Using a commercially available kinesiology band we developed an anal tape to be applied to the anus with the aim to determine its impact on symptom bother and quality of life. METHODS: Four-week prospective, self-controlled, pilot study of patients with FI. The primary outcome was improvement in any of the four domains (lifestyle, coping/behavior, depression/self-perception, embarrassment) evaluated by the "Fecal Incontinence Quality of Life Scale." Secondary outcomes included improvement in frequency of incontinence events and safety. Days 0-14 served as control period and days 15-28 as study period. Patients were asked to rate their satisfaction and willingness to use the device in the future using a 10-cm continuous visual analog scale. RESULTS: Twenty patients completed the study. Median age was 64 years; all patients were females. Significant improvements were observed in all domains of the Fecal Incontinence Quality of Life Scale from baseline to day 28 (p < 0.001 for all) and in three of four domains between day 15 and 28 (p < 0.04) but not between days 1 and 14. Five patients (25%) had a ≥ 50% improvement in incontinence events. Patients reported satisfaction and willingness to use the anal tape in the future. Other than mild difficulty to remove the anal tape, no adverse events were reported. CONCLUSIONS: In this small pilot study, the use of the anal tape was safe and effective. The primary outcome of significant improvement in quality of life was achieved ( ClinicalTrials.gov ID:NCT02989545). PUBLIC TRIAL REGISTRY: ClinicalTrials.gov identifier NCT02989545. https://clinicaltrials.gov/ct2/show/NCT02989545.
INTRODUCTION AND HYPOTHESIS: Fecal incontinence is a debilitating condition with a devastating impact on quality of life. Using a commercially available kinesiology band we developed an anal tape to be applied to the anus with the aim to determine its impact on symptom bother and quality of life. METHODS: Four-week prospective, self-controlled, pilot study of patients with FI. The primary outcome was improvement in any of the four domains (lifestyle, coping/behavior, depression/self-perception, embarrassment) evaluated by the "Fecal Incontinence Quality of Life Scale." Secondary outcomes included improvement in frequency of incontinence events and safety. Days 0-14 served as control period and days 15-28 as study period. Patients were asked to rate their satisfaction and willingness to use the device in the future using a 10-cm continuous visual analog scale. RESULTS: Twenty patients completed the study. Median age was 64 years; all patients were females. Significant improvements were observed in all domains of the Fecal Incontinence Quality of Life Scale from baseline to day 28 (p < 0.001 for all) and in three of four domains between day 15 and 28 (p < 0.04) but not between days 1 and 14. Five patients (25%) had a ≥ 50% improvement in incontinence events. Patients reported satisfaction and willingness to use the anal tape in the future. Other than mild difficulty to remove the anal tape, no adverse events were reported. CONCLUSIONS: In this small pilot study, the use of the anal tape was safe and effective. The primary outcome of significant improvement in quality of life was achieved ( ClinicalTrials.gov ID:NCT02989545). PUBLIC TRIAL REGISTRY: ClinicalTrials.gov identifier NCT02989545. https://clinicaltrials.gov/ct2/show/NCT02989545.