Fecal Incontinence
Conditions
Keywords
fecal incontinence, bowel control
Brief summary
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.
Interventions
DEVICEvaginal bowel control system (LivSure)
Sponsors
Pelvalon, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* History of FI for at least 6 months * Baseline diary requirement for min # of FI episodes in a two-week period * Ability to manage investigational device insertion and removal * Successful fitting of study device * Willing and able to give written informed consent to participate in the study
Exclusion criteria
* Chronic rectal, anal or pelvic pain * Any vaginal prolapse that extends beyond the plane of the hymen. * Previous rectal or pelvic floor surgery within the last 12 months (24 months in the case of cancer) * Congenital anorectal malformation * Chronic watery diarrhea unmanageable by drugs or diet as primary cause of FI * Inflammatory bowel disease * Presence of a vaginal, anal, rectal or urethral fistula or anastomosis * Presence of a vaginal, rectal or bladder tumor * Presence of an open wound or tear in the vagina or anus by exam * Presence or history of rectovaginal fistula * Atrophic vaginal tissue as determined by symptoms or visualization * Current vaginal or urinary infection requiring treatment * History of recurrent urinary or vaginal infections * Subject is currently pregnant or planning pregnancy in next 5 months * Concurrent use of any intra-vaginal device that would interfere with LivSure (now called Eclipse) placement or wearing * Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.) or other factor that the investigator believes would interfere with study participation and/or increase subject risk
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of FI Episodes | 1 Month | Subjects with at least a 50% reduction in FI episodes (major or minor soiling) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Incontinent Days | 1 Month | 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 |
| Device-related Adverse Events | 1month | The number of overall adverse events rated as probably or definitely related to the study device. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited primarily through Investigators' private practices with some additional participants recruited through IRB approved advertisements between 14 Aug 2012 through Nov. 2013.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| All Subjects All subjects who completed the fitting process (a screening criteria) and entered the treatment period. | 61 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 2 |
| Overall Study | Unrelated health issue | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 60.8 years STANDARD_DEVIATION 9.4 |
| Body Mass Index <18.5 | 2 participants |
| Body Mass Index 18.5-24.9 | 20 participants |
| Body Mass Index 25.0-29.9 | 21 participants |
| Body Mass Index >29.9 | 18 participants |
| FI Symptom Duration > 5 years | 26 participants |
| FI Symptom Duration 6 months - 5 years | 35 participants |
| Menopause Status Not reported | 1 participants |
| Menopause Status Peri-menopause | 2 participants |
| Menopause Status Post-menopause | 51 participants |
| Menopause Status Pre-menopause | 7 participants |
| Number of FI episodes in 2-week period | 11.7 episodes STANDARD_DEVIATION 9.1 |
| Parity No. of pregnancies | 2 events |
| Parity No. of vaginal births | 2 events |
| Previous Gynecologic Surgeries Hysterectomy | 29 participants |
| Previous Gynecologic Surgeries Other gynecologic surgery | 25 participants |
| Previous Gynecologic Surgeries Prolapse surgery | 5 participants |
| Previous Gynecologic Surgeries Urinary incontinence surgery | 9 participants |
| Previous treatment for FI Biofeedback | 11 participants |
| Previous treatment for FI Other [n=60] | 6 participants |
| Previous treatment for FI Surgery | 4 participants |
| Previous treatment for FI Surgical implant of electrical stimulator [n=60] | 1 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants |
| Race/Ethnicity, Customized Asian | 2 participants |
| Race/Ethnicity, Customized Black | 10 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 3 participants |
| Race/Ethnicity, Customized Natrive Hawaiian or Other Pacific Islander | 0 participants |
| Race/Ethnicity, Customized Other | 1 participants |
| Race/Ethnicity, Customized White | 45 participants |
| Region of Enrollment United States | 61 participants |
| Sex: Female, Male Female | 61 Participants |
| Sex: Female, Male Male | 0 Participants |
| Sexual Activity Greater than or equal to 1 x month | 27 participants |
| Sexual Activity Less than 1 x per month | 33 participants |
| Sexual Activity Not reported | 1 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 36 / 61 |
| serious Total, serious adverse events | 1 / 61 |
Outcome results
Primary
Frequency of FI Episodes
Subjects with at least a 50% reduction in FI episodes (major or minor soiling)
Time frame: 1 Month
Population: Subjects who were successfully fit with the VBC device.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects Fit With the VBC Device [ITT] | Frequency of FI Episodes | 79 percentage of participants |
| Subject Fit With the VBC Device [PP] | Frequency of FI Episodes | 86 percentage of participants |
Secondary
Device-related Adverse Events
The number of overall adverse events rated as probably or definitely related to the study device.
Time frame: 1month
Population: All subjects who were exposed to the VBC device (now called Eclipse) during the Treatment Period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects Fit With the VBC Device [ITT] | Device-related Adverse Events | 18 events |
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
Time frame: 1 Month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects Fit With the VBC Device [ITT] | Number of Incontinent Days | # Episodes reported at Baseline | 11.6 days | Standard Deviation 9.5 |
| Subjects Fit With the VBC Device [ITT] | Number of Incontinent Days | # Episodes reported at 1 Month | 2.1 days | Standard Deviation 2.9 |