Trial Outcomes & Findings for A Clinical Evaluation of a Vaginal Bowel Control System for the Treatment of Fecal Incontinence in Women (LIFE) (NCT NCT01655498)

NCT ID: NCT01655498

Last Updated: 2015-05-27

Results Overview

Subjects with at least a 50% reduction in FI episodes (major or minor soiling)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 61 participants
• Primary outcome timeframe: 1 Month
• Results posted on: 2015-05-27

Participant Flow

Participants were recruited primarily through Investigators' private practices with some additional participants recruited through IRB approved advertisements between 14 Aug 2012 through Nov. 2013.

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).

Participant milestones

Measure	All Subjects All subjects who completed the fitting process and entered the treatment period, comprised the Intent-to-treat population.
Overall Study STARTED	61
Overall Study COMPLETED	56
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	All Subjects All subjects who completed the fitting process and entered the treatment period, comprised the Intent-to-treat population.
Overall Study Unrelated health issue	2
Overall Study Protocol Violation	2
Overall Study Withdrawal by Subject	1

Baseline Characteristics

A Clinical Evaluation of a Vaginal Bowel Control System for the Treatment of Fecal Incontinence in Women (LIFE)

Baseline characteristics by cohort

Measure	All Subjects n=61 Participants All subjects who completed the fitting process (a screening criteria) and entered the treatment period.
Age, Continuous	60.8 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized White	45 participants n=5 Participants
Race/Ethnicity, Customized Asian	2 participants n=5 Participants
Race/Ethnicity, Customized Black	10 participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	3 participants n=5 Participants
Race/Ethnicity, Customized Natrive Hawaiian or Other Pacific Islander	0 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants
Region of Enrollment United States	61 participants n=5 Participants
Body Mass Index <18.5	2 participants n=5 Participants
Body Mass Index 18.5-24.9	20 participants n=5 Participants
Body Mass Index 25.0-29.9	21 participants n=5 Participants
Body Mass Index >29.9	18 participants n=5 Participants
Previous Gynecologic Surgeries Hysterectomy	29 participants n=5 Participants
Previous Gynecologic Surgeries Prolapse surgery	5 participants n=5 Participants
Previous Gynecologic Surgeries Urinary incontinence surgery	9 participants n=5 Participants
Previous Gynecologic Surgeries Other gynecologic surgery	25 participants n=5 Participants
Sexual Activity Greater than or equal to 1 x month	27 participants n=5 Participants
Sexual Activity Less than 1 x per month	33 participants n=5 Participants
Sexual Activity Not reported	1 participants n=5 Participants
Parity No. of pregnancies	2 events n=5 Participants
Parity No. of vaginal births	2 events n=5 Participants
Menopause Status Pre-menopause	7 participants n=5 Participants
Menopause Status Peri-menopause	2 participants n=5 Participants
Menopause Status Post-menopause	51 participants n=5 Participants
Menopause Status Not reported	1 participants n=5 Participants
Number of FI episodes in 2-week period	11.7 episodes STANDARD_DEVIATION 9.1 • n=5 Participants
FI Symptom Duration 6 months - 5 years	35 participants n=5 Participants
FI Symptom Duration > 5 years	26 participants n=5 Participants
Previous treatment for FI Surgery	4 participants n=5 Participants
Previous treatment for FI Surgical implant of electrical stimulator [n=60]	1 participants n=5 Participants
Previous treatment for FI Biofeedback	11 participants n=5 Participants
Previous treatment for FI Other [n=60]	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Month

Population: Subjects who were successfully fit with the VBC device.

Subjects with at least a 50% reduction in FI episodes (major or minor soiling)

Outcome measures

Measure	Subjects Fit With the VBC Device [ITT] n=61 Participants ITT cohort is defined as all subjects who were successfully fit with a VBC device (now called Eclipse Insert) during the Fitting Period	Subject Fit With the VBC Device [PP] n=56 Participants Per Protocol cohort is defined all all subjects who were successfully fit with a VBC device (now called Eclipse Insert) during the Fitting Period who also completed the study without any major protocol deviations
Frequency of FI Episodes	79 percentage of participants	86 percentage of participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Subjects Fit With the VBC Device [ITT] n=56 Participants ITT cohort is defined as all subjects who were successfully fit with a VBC device (now called Eclipse Insert) during the Fitting Period	Subject Fit With the VBC Device [PP] Per Protocol cohort is defined all all subjects who were successfully fit with a VBC device (now called Eclipse Insert) during the Fitting Period who also completed the study without any major protocol deviations
Number of Incontinent Days # Episodes reported at 1 Month	2.1 days Standard Deviation 2.9	—
Number of Incontinent Days # Episodes reported at Baseline	11.6 days Standard Deviation 9.5	—

SECONDARY outcome

Timeframe: 1month

Population: All subjects who were exposed to the VBC device (now called Eclipse) during the Treatment Period.

The number of overall adverse events rated as probably or definitely related to the study device.

Outcome measures

Measure	Subjects Fit With the VBC Device [ITT] n=61 Participants ITT cohort is defined as all subjects who were successfully fit with a VBC device (now called Eclipse Insert) during the Fitting Period	Subject Fit With the VBC Device [PP] Per Protocol cohort is defined all all subjects who were successfully fit with a VBC device (now called Eclipse Insert) during the Fitting Period who also completed the study without any major protocol deviations
Device-related Adverse Events	18 events	—

Adverse Events

ITT Cohort [N=61]

Serious events: 1 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Measure	ITT Cohort [N=61] n=61 participants at risk Adverse Events reported during the Screening and 1-Month Treatment Period.
Infections and infestations Flu symptoms	1.6% 1/61 • 1 month Treatment Period

Other adverse events

Measure	ITT Cohort [N=61] n=61 participants at risk Adverse Events reported during the Screening and 1-Month Treatment Period.
Reproductive system and breast disorders Pelvic cramping or discomfort	26.2% 16/61 • Number of events 16 • 1 month Treatment Period
Reproductive system and breast disorders Pelvic pain	9.8% 6/61 • Number of events 6 • 1 month Treatment Period
Renal and urinary disorders Urinary incontinence	9.8% 6/61 • Number of events 6 • 1 month Treatment Period
Gastrointestinal disorders Difficulty with Stool Evacuation	6.6% 4/61 • Number of events 4 • 1 month Treatment Period
Renal and urinary disorders Urinary urgency or frequency	6.6% 4/61 • Number of events 4 • 1 month Treatment Period
Reproductive system and breast disorders Vaginal Spotting	8.2% 5/61 • Number of events 5 • 1 month Treatment Period

Additional Information

Director of Clinical

Pelvalon

Phone: 650-276-0130

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60