Our objective here is to improve the patient's compliance and accurate capture of patient reported bowel and abdominal symptoms, by utilizing a phone application that interactively records each bowel movement or leakage event and other bowel symptoms. Such an electronic stool diary may relieve the burden of using a paper daily stool diary. We will compare and validate the electronic stool diary with the paper stool diary.
Fecal incontinence consists of multiple and often unpredictable bowel movements and leakage of stool. Chronic constipation is associated with episodes of irregular and unpredictable bowel habits and difficulty with remembering symptoms. These features lead to a recall bias, and inaccurate recollection and/or documentation of symptoms that are critical for diagnosis and management. A daily stool diary has been used in clinical trials and in clinical practice to accurately record bowel symptoms. However, patients find these diary entries cumbersome or embarrassing to use, especially with bowel movements that occur outside of home resulting in loss of data or inaccurate collection of information. Also, many patients forget events especially when this bowel habit is irregular. Therefore, it is crucial to explore new ways of accurately, reliability, and more discretely collect bowel habit information, by using current technology that a majority of people have access to.
Study Type
OBSERVATIONAL
Enrollment
135
Subjects will be asked to complete a 2 week paper stool diary.
Subjects will be asked to complete a 2 week paper stool diary.
Digestive Health Clinical Research
Augusta, Georgia, United States
RECRUITINGCorrelation of electronic APP diary information with paper form stool diary in healthy subjects
The stool diary parameters: number of bowel movements, number of leakages, stool consistency, urgency, time spent on toilet, feeling of incomplete evacuation,straining, gas and bloating recorded in the paper form stool diary over 2 weeks will be correlated with the electronic APP stool diary parameters using Pearson correlation in healthy subjects.
Time frame: 2 weeks each
Correlation of electronic APP diary information with paper form stool diary in fecal incontinence subjects
The stool diary parameters; number of bowel movements, number of leakages, stool consistency, urgency, sensation before leakage, feeling of incomplete evacuation,use of pads and medication use recorded in the paper form stool diary over 2 weeks will be correlated with the electronic APP stool diary parameters using Pearson correlation in fecal incontinence subjects
Time frame: 2 weeks each
The stool diary parameters
The stool diary parameters: number of bowel movements, stool consistency, urgency, time spent on toilet, feeling of incomplete evacuation,straining, gas and bloating recorded in the paper form stool diary over 2 weeks will be correlated with the electronic APP stool diary parameters using Pearson correlation in constipation subjects
Time frame: 2 weeks each
Stool frequency
The number of bowel movements per week (BM), the number of spontaneous bowel movements (SBM), and the number of complete spontaneous bowel movements (CSBM) will be compared between the APP and stool diary and between healthy subjects and patients with constipation and fecal incontinence.
Time frame: 2 weeks
Stool consistency
Stool consistency (Bristol Stool scale, 1-7): 1-very hard stool, 4- normal, smooth stool, 7- watery stool, will be compared between the APP and stool diary and between healthy subjects and patients with constipation and fecal incontinence.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 2 weeks
Bowel urgency
Severity of bowel urgency- unable to postpone BM for more than 15 minutes, will be compared between the APP and stool diary and between healthy subjects and patients with constipation and fecal incontinence.
Time frame: 2 weeks
Stool leakage
Leakage characteristics-amount: 0- none, 1-mild, 2-moderate, 3- excessive, will be compared between the APP and stool diary and between healthy subjects and patients with fecal incontinence.
Time frame: 2 weeks
Complete evacuation
Feeling of complete evacuation, will be compared between the APP and stool diary and between healthy subjects and patients with constipation and fecal incontinence.
Time frame: 2 weeks
Week 1 vs Week 2 reproducibility of APP and paper diary
Compare the results for the first and the second week for the electronic APP data as well as paper data and examine the reproducibility.
Time frame: 1 weeks
Straining
Stool straining will be compared between the APP and stool diary and between healthy subjects and patients with constipation.
Time frame: 2 weeks
Time spent of toilet
Time spent on toilet will be compared between the APP and stool diary and between healthy subjects and patients with constipation.
Time frame: 2 weeks