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The objective of this study is to obtain preliminary efficacy and safety data on the use of the LivSure System (now called the "Eclipse™ System") in women with fecal incontinence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal Bowel Control | Experimental | A vaginal bowel control system intended to manage fecal incontinence. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vaginal bowel control system (LivSure) | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of FI Episodes | Subjects with at least a 50% reduction in FI episodes (major or minor soiling) | 1 Month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Incontinent Days | Change in number of incontinent days while wearing the device during the 2-week assessment period as compared to the baseline 2-week assessment period | 1 Month |
| Device-related Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Holly Richter, PhD, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27564386 | Derived | Matthews CA, Varma MG, Takase-Sanchez MM, Hale DS, Van Drie D, Muir T, Wells E, Jannelli M, Richter HE. Characteristics Associated With Successful Fitting of a Vaginal Bowel Control System for Fecal Incontinence. Female Pelvic Med Reconstr Surg. 2016 Sep-Oct;22(5):359-63. doi: 10.1097/SPV.0000000000000290. | |
| 25730213 | Derived |
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200 subjects were consented:
Pre-fitting screen fails: vaginal anatomical exclusions (13), logistics issues (12), LTFU (5), other (16).
Baseline diary screen fails: (44).
Post-fitting screen fails: unsatisfactory fit (28), unable to manage device (4), LTFU (1), logistics issues (2), withdrawal (14).
Participants were recruited primarily through Investigators' private practices with some additional participants recruited through IRB approved advertisements between 14 Aug 2012 through Nov. 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects | All subjects who completed the fitting process and entered the treatment period, comprised the Intent-to-treat population. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
All subjects who were successfully fit with the VBC device (now called Eclipse)
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All subjects who completed the fitting process (a screening criteria) and entered the treatment period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency of FI Episodes | Subjects with at least a 50% reduction in FI episodes (major or minor soiling) | Subjects who were successfully fit with the VBC device. | Posted | Number | percentage of participants | 1 Month |
|
1 month Treatment Period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ITT Cohort [N=61] | Adverse Events reported during the Screening and 1-Month Treatment Period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flu symptoms | Infections and infestations | Systematic Assessment | Required hospitalization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pelvic cramping or discomfort | Reproductive system and breast disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical | Pelvalon | 650-276-0130 |
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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The number of overall adverse events rated as probably or definitely related to the study device.
| 1month |
| Richter HE, Matthews CA, Muir T, Takase-Sanchez MM, Hale DS, Van Drie D, Varma MG. A vaginal bowel-control system for the treatment of fecal incontinence. Obstet Gynecol. 2015 Mar;125(3):540-547. doi: 10.1097/AOG.0000000000000639. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Number | participants |
|
| Previous Gynecologic Surgeries | Number | participants |
|
| Sexual Activity | Number | participants |
|
| Parity | Median | Full Range | events |
|
| Menopause Status | Number | participants |
|
| Number of FI episodes in 2-week period | Mean | Standard Deviation | episodes |
|
| FI Symptom Duration | Number | participants |
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| Previous treatment for FI | Number | participants |
|
|
|
| Secondary | Number of Incontinent Days | Change in number of incontinent days while wearing the device during the 2-week assessment period as compared to the baseline 2-week assessment period | Posted | Mean | Standard Deviation | days | 1 Month |
|
|
|
| Secondary | Device-related Adverse Events | The number of overall adverse events rated as probably or definitely related to the study device. | All subjects who were exposed to the VBC device (now called Eclipse) during the Treatment Period. | Posted | Number | events | 1month |
|
|
|
| 1 |
| 61 |
| 36 |
| 61 |
|
| Pelvic pain | Reproductive system and breast disorders | Systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | Systematic Assessment |
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| Difficulty with Stool Evacuation | Gastrointestinal disorders | Systematic Assessment |
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| Urinary urgency or frequency | Renal and urinary disorders | Systematic Assessment |
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| Vaginal Spotting | Reproductive system and breast disorders | Systematic Assessment |
|
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