Trial · NCT02628626
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants to Report a 50% or Greater Reduction in Weekly Fecal Incontinence (FI) Episodes | 4 weeks | The number of participants that report a 50% or greater reduction in weekly incontinent episodes as measured by self-reported bowel diaries. |
| Secondary | Daily Stool Frequency | 4 weeks | The number of bowel movements daily measured by self-reported bowel diaries. |
| Secondary | Stool Consistency | 4 weeks | Stool consistency as measured by self-reported bowel diaries. Expressed in terms of the Bristol Stool Form Scale, where: 1= separate hard lumps; 2= lumpy sausage-shape; 3= cracked sausage; 4= smooth and soft sausage; 5=soft blobs; 6=mushy, fluffy pieces; 7= watery, no solid pieces. |
| Secondary | Number of Semi-Formed Stools Per Week | 4 weeks | The number of stools per week measured by self-reported bowel diaries where the Bristol stool score was 5, 6, or 7. (5=soft blobs; 6=mushy, fluffy pieces; 7= watery, no solid pieces) |
| Secondary | Delay of Bowel Movement | 4 weeks | The time in minutes a bowel movement can be delayed after sense of urgency to defecate as measured by self-reported bowel diaries. |
| Secondary | Total Fecal Incontinence Episodes | 4 weeks | The total number of fecal incontinence episodes per week as measured by self-reported bowel diaries. |
| Secondary | Volume of Fecal Incontinence | 4 weeks | The volume of fecal incontinence measured as the number of incontinent episodes per week as categorized by small (staining only), moderate (requiring change of underwear) or large (requiring change of all clothes) in self-reported bowel diaries. |
| Secondary | Percent of Incontinent Bowel Movements Pre-treatment | baseline | The percentage of bowel movements that were incontinent prior to treatment initiation, per self-reported bowel diaries. |
| Secondary | Percent of Incontinent Bowel Movements During Treatment | 4 weeks | The percentage of bowel movements that were incontinent during treatment, per self-reported bowel diaries. |
| Secondary | Percent of Incontinent Bowel Movements to be Semi-Formed Stools Pre-Treatment | baseline | The percentage of incontinent bowel movements where the Bristol stool score was 5, 6 or 7. (5=soft blobs; 6=mushy, fluffy pieces; 7= watery, no solid pieces), pre-treatment, per self-reported bowel diaries. |
| Secondary | Percent of Incontinent Bowel Movements to be Semi-Formed Stools During Treatment | 4 weeks | The percentage of incontinent bowel movements where the Bristol stool score was 5, 6 or 7. (5=soft blobs; 6=mushy, fluffy pieces; 7= watery, no solid pieces) during treatment, per self-reported bowel diaries. |
| Secondary | Severity of Bowel Symptoms | 4 weeks | The Fecal Incontinence Symptom Severity (FISS) score is based on five questions; (1) the frequency of FI; (2) the type of FI (stool only, liquid or mucus only, both liquid/mucus and stool, or gas only); (3) the amount of stool leaked (small, moderate, or large); (4) the frequency of having to rush to the toilet; and (5) the frequency of having stool leak without warning. Questions 4 \& 5 are merged to determine if the participant has passive FI (FI without warning), urge FI, both, or neither. The responses to the questions are assigned physician-derived weights and added together for a total score of 4 to 13. The higher the score the more severe the FI symptoms. |
| Secondary | Severity of Fecal Incontinence | 4 weeks | Measured by the Fecal Incontinence Severity Index (FISI). It is a validated 4-item scale used to assess the frequency (never, 1-3 times a month, once a week, 2 or more times per week but not daily, once a day, 2 or more times per day) of 4 different types of FI (gas, mucus, liquid stool, solid stool). Each of the four types of FI is awarded a number of points, depending on the frequency at which that type of incontinence is experienced. The points are totaled and the scores can range from 0 to 61, where the higher the score, the higher the perceived severity of the fecal incontinence. |
| Secondary | Fecal Incontinence Quality of Life (FI-QoL) | 4 weeks | The Fecal Incontinence Quality of Life questionnaire measures specific quality of life issues expected to affect patients with fecal incontinence. The questions are grouped into four categories: lifestyle (10 questions), coping (9 questions), depression (7 questions), and embarrassment (3 questions). Each category is scored from 1 to 4. The scale scores are calculated by adding the numerical values of all responses in that specific scale and then dividing by its number of items. Higher scores indicate a better quality of life. |
| Secondary | Loperamide Tablets Per Week | 4 weeks | The number of tablets of loperamide used, per self-reported bowel diaries. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02628626/registered