An interventional study of vaginal bowel control system (LivSure) in Fecal Incontinence, sponsored by Pelvalon, Inc.. Completed at 1 site in United States. Open to female participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-05-27.
Sponsored by Pelvalon, Inc. · Not applicable, Interventional, and Treatment
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.
312 studies on the registry are indexed under Fecal Incontinence; 57 are open to participants now.
This study's enrollment of 61 is above the median of 50 across 216 interventional studies indexed under Fecal Incontinence.
Browse Fecal Incontinence studies →Pelvalon, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A vaginal bowel control system intended to manage fecal incontinence.
Device: vaginal bowel control system (LivSure)
Also known as: LivSure System, Eclipse™ System
Frequency of FI Episodes
Subjects with at least a 50% reduction in FI episodes (major or minor soiling)
Time frame: 1 Month
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
Time frame: 1 Month
Device-related Adverse Events
The number of overall adverse events rated as probably or definitely related to the study device.
Time frame: 1month
Participants were recruited primarily through Investigators' private practices with some additional participants recruited through IRB approved advertisements between 14 Aug 2012 through Nov. 2013.
| Milestone | All Subjects |
|---|---|
| Started | 61 |
| Completed | 56 |
| Not completed | 5 |
| Withdrew: Unrelated health issue | 2 |
| Withdrew: Protocol violation | 2 |
| Withdrew: Withdrawal by subject | 1 |
Subjects with at least a 50% reduction in FI episodes (major or minor soiling)
| percentage of participants | Subjects Fit With the VBC Device [ITT] | Subject Fit With the VBC Device [PP] |
|---|---|---|
| Frequency of FI Episodes | 79 | 86 |
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
| days | Subject Fit With the VBC Device [PP] |
|---|---|
| # Episodes reported at 1 Month | 2.1 ± 2.9 |
| # Episodes reported at Baseline | 11.6 ± 9.5 |
The number of overall adverse events rated as probably or definitely related to the study device.
| events | ITT Cohort [N=61] |
|---|---|
| Device-related Adverse Events | 18 |
Collected over 1 month Treatment Period. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ITT Cohort [N=61] | — | 1/61 (1.6%) | 36/61 (59%) |
| Event | ITT Cohort [N=61] |
|---|---|
| Flu symptomsInfections and infestations | 1/61 |
| Event | ITT Cohort [N=61] |
|---|---|
| Pelvic cramping or discomfortReproductive system and breast disorders | 16/61 |
| Pelvic painReproductive system and breast disorders | 6/61 |
| Urinary incontinenceRenal and urinary disorders | 6/61 |
| Vaginal SpottingReproductive system and breast disorders | 5/61 |
| Difficulty with Stool EvacuationGastrointestinal disorders | 4/61 |
| Urinary urgency or frequencyRenal and urinary disorders | 4/61 |
All subjects who were successfully fit with the VBC device (now called Eclipse)
| Age, Continuous(years) | All Subjects |
|---|---|
| Mean | 60.8 ± 9.4 |
| Sex: Female, Male(Participants) | All Subjects |
|---|---|
| Female | 61 |
| Male | 0 |
| Race/Ethnicity, Customized(participants) | All Subjects |
|---|---|
| White | 45 |
| Asian | 2 |
| Black | 10 |
| American Indian or Alaska Native | 0 |
| Hispanic or Latino | 3 |
| Natrive Hawaiian or Other Pacific Islander | 0 |
| Other | 1 |
| Region of Enrollment(participants) | All Subjects |
|---|---|
| United States | 61 |
| Body Mass Index(participants) | All Subjects |
|---|---|
| <18.5 | 2 |
| 18.5-24.9 | 20 |
| 25.0-29.9 | 21 |
| >29.9 | 18 |
| Previous Gynecologic Surgeries(participants) | All Subjects |
|---|---|
| Hysterectomy | 29 |
| Prolapse surgery | 5 |
| Urinary incontinence surgery | 9 |
| Other gynecologic surgery | 25 |
| Sexual Activity(participants) | All Subjects |
|---|---|
| Greater than or equal to 1 x month | 27 |
| Less than 1 x per month | 33 |
| Not reported | 1 |
| Parity(events) | All Subjects |
|---|---|
| No. of pregnancies | 2 (0 to 12) |
| No. of vaginal births | 2 (0 to 4) |
4 further baseline measures are reported on the registry.
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Pelvalon, Inc.