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
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Availability of data and material
The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Code availability
Not applicable.
Abbreviations
- EAUS:
-
Endoanal ultrasound
- FI :
-
Fecal incontinent
- FIQoLS :
-
Fecal Incontinence Quality of Life Scale
- IQR:
-
Interquartile range
- MICD:
-
Minimum clinically important difference
- OASIS:
-
Obstetric anal sphincter injuries
- QoL:
-
Quality of life
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Funding
No external funding was used for this study; all costs were covered by the internal budget of our department.
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Contributions
Dan M Livovsky: Conceptualization; Data curation; Formal analysis of results; Conducting of investigations; Conceptualization of methodology, Writing of manuscript. This author has approved the final draft submitted.
Benjamin Koslowsky: Data curation; Review and editing of original draft.
Eran Goldin: Funding acquisition (internal, no external founding was used in this study): supervisor of the project, administrator of resources.
Joseph Lysy: Original idea and concept, data curation; Analysis of data; Funding acquisition; Conducted investigation and responsible for patient care; Methodology review; Project administration: supervision of project: review and editing of original draft.
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The study protocol conforms to the ethical guidelines of the 1975 Declaration of Helsinki and was approved, a priori, by the ethics review board of ShaareZedek Medical Center (approval date and number: 21/02/2016; 0229–16-SZMC).
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Witten informed consent was obtained from all patients before participation in any of the study procedures.
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Livovsky, D.M., Koslowsky, B., Goldin, E. et al. External kinesiology tape for improvement in fecal incontinence symptom bother in women: a pilot study. Int Urogynecol J 33, 2859–2868 (2022). https://doi.org/10.1007/s00192-021-05050-z
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DOI: https://doi.org/10.1007/s00192-021-05050-z