Trial · NCT02008565
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline St. Mark's (Vaizey) Score | 12 and 24 weeks | An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks. | units on a scale | MEAN |
| SECONDARY | Change in Quality of Life on Colorectal-Anal Distress Inventory (CRADI) | 12 and 24 weeks | An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks. | units on a scale | MEAN |
| SECONDARY | Change in Colorectal-Anal Subscale of the Pelvic Floor Impact Questionnaire Short Form (CRAIQ) Score | 12 and 24 weeks | An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks. | units on a scale | MEAN |
| SECONDARY | Change From Baseline Accident-free Days at 12 and 24 Weeks | 12 and 24 weeks | An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks. | accident-free days | MEAN |
| SECONDARY | Change From Baseline Pad-change Leaks Per Day at 12 and 24 Weeks | 12 and 24 weeks | An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks. | pad-change leaks per day | MEAN |
| SECONDARY | Change From Baseline Pad-change Leaks Per Week at 12 and 24 Weeks | 12 and 24 weeks | An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks. | pad-change leaks per week | MEAN |
| SECONDARY | Change From Baseline Total Number of Leaks Per Day at 12 and 24 Weeks | 12 and 24 weeks | An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks. | leaks per day | MEAN |
| SECONDARY | Change in Fecal Incontinence Severity Index (FISI) Score | 12 and 24 weeks | An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks. | units on a scale | MEAN |
| SECONDARY | Participants With Improvement in Patient Global Impression of Improvement (PGI-I) Score | 12 and 24 Weeks | An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline Resting Anal Canal Pressures (mm of Hg) at 2 cm, 1 cm, and 0 cm Insertion at 12 and 24 Weeks | 12 and 24 weeks | An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks. | resting anal canal pressure (mm Hg) | MEAN |
| SECONDARY | Change From Baseline Volume of Air (mL) at First Sensation for Perception of Rectal Distention at 12 and 24 Weeks | 12 and 24 weeks | An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks. | volume of air (mL) | MEAN |
| SECONDARY | Change From Baseline Volume of Air (mL) at Urge to Defecate at 12 and 24 Weeks | 12 and 24 weeks | An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks. | volume of air (mL) | MEAN |
| SECONDARY | Change From Baseline Maximum Anal Pressures During Squeeze With the Catheter at the HPZ at 12 and 24 Weeks | 12 and 24 weeks | An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks. | max. anal canal pressure squeeze (mmHg) | MEAN |
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.
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GET https://conductscience.org/api/trials/v1/NCT02008565/outcomes