LIBERATE: A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women

• Sponsor: Pelvalon, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02428595
• Collaborator: (none)
• Enrollment: 137
• Locations: 11
• Arm: 1
• Actual Duration (Months): 38.1
• Patients Per Site: 12.5
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Multi-center, prospective, within-subject control, open label clinical trial to evaluate the durability of the safety and effectiveness of the Eclipse™ System after 3 and 12 months of use.

Condition or Disease	Intervention/Treatment	Phase
Fecal Incontinence	Device: Eclipse™ System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 137 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women
• Actual Study Start Date: May 15, 2015
• Actual Primary Completion Date: Jul 18, 2018
• Actual Study Completion Date: Jul 18, 2018

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Treatment Eclipse™ System

Device: Eclipse™ System; The Eclipse System is a vaginal bowel control (VBC) therapy intended to provide bowel control for women with fecal incontinence. It is comprised of a non-surgical device placed in the vagina (referred to as the "Eclipse Insert") and a pressure-regulated pump which is used to inflate and deflate the Insert. A Sizing Kit, for use during the fitting process, and an evaluation Insert (referred to as the Trial Insert) are also part of the Eclipse System.; Other Names: Vaginal Bowel Control (VBC) Therapy

Outcome Measures

Primary Outcome Measures

1. Count of Treatment Responders in the Intent to Treat (ITT) Cohort [3 months]

   Count of patients with >50% reduction in the average number of FI episodes per week as compared to baseline.

Secondary Outcome Measures

1. Count of Treatment Responders in the Per Protocol (PP) Population [3, 6 and 12 months]

   Count of patients with >50% reduction in the average number of FI episodes per week as compared to Baseline.

2. Change in St. Mark's (Vaizey) Incontinence Severity Score as Compared to Baseline [12 months]

   Change in mean scores on subject-reported outcomes related to symptom severity as reported by St. Mark's (Vaizey) Incontinence Severity Score. St. Mark's is a validated scale widely used in fecal incontinence research. The scale has a 24 point range where 0 = total fecal continence (better outcome) and 24 = total fecal incontinence (worse outcome). A reduction in the St. Mark's score is a better outcome.

3. Change in Fecal Incontinence Quality of Life (FIQoL) Score as Compared to Baseline [12 months]

   Change in mean score (from Baseline) on subject-reported outcomes as reported by FIQoL (Fecal Incontinence Quality of Life) score. The FIQoL scale asks a number of Fecal Incontinence (FI) related questions. Patient responses are rated from 1 to 4 points except one question which is rated from 1 to 5 points. The questions fall into four subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. The score for each subscale is the average of the responses in that group. For depression/self-perception the subscale score is from 1.0 to 5.0. The other subscale scores are from 1.0 to 4.0. The total FIQoL score is the sum of all four subscales, ranging from 4 to 17. For each subscale and the combined score, lower values indicate worse quality of life and higher values indicate better quality of life. An increase in score as compared to Baseline is therefore a better outcome.

4. Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores [3, 6, 9 and 12 months]

   The Patient Global Impression of Improvement (PGI-I) is a scale which describes the patient's perception of how their symptoms have change from Baseline. The scale has a range of 7 points from 1 to 7, where 1 = very much better than Baseline and 7 = very much worse than Baseline and 4 = no change from Baseline. A score below 4 is a better outcome and a score above 4 is a worse outcome, and a score of 4 is a neutral outcome. Note that because the patient is being asked to compare their symptoms to Baseline, no data is taken for this scale at Baseline and the score is an absolute value, not a change from a previous score.

Other Outcome Measures

1. Safety Endpoint - Number of Device Related Adverse Events [3, 6, 9 and 12 months]

   The number of device-related adverse events and device-related serious adverse events (related defined as probably or definitely). Events are classified as occurring either during fitting (the process of identifying the correct size of the device) or during treatment (defined as the time when a patient receives their long term wear device until the completion of the study).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Abbreviated Inclusion Criteria:

• History of Fecal Incontinence (FI) for at least 6 months

• Subject willing and able to give written informed consent to participate in the study

• Subject can read, write and communicate fluently in English

• Subject willing and able to comply with visit schedule

• Subject is able to physically manage the insertion and removal of the Insert

Abbreviated Exclusion Criteria:

• Vaginal childbirth within the last 18 months

• Currently pregnant or planning pregnancy during the study period

• Acute infections or genito-urinary injuries that would impact comfortable device use

• Current treatment for Fecal Incontinence other than medical management

• Removal or diversion of any portion of the bowel

• Recent urogenital or colorectal surgeries

• Chronic abdominal pain in absence of diarrhea

• Chronic (>6 mos) rectal, anal or pelvic pain

• Chronic watery diarrhea, unmanageable by drugs or diet

• Inflammatory Bowel Disease (IBD) such as Chron's or Ulcerative Colitis

• Rectal prolapse (mucosal or full thickness)

• Grade III or IV hemorrhoids

• Pelvic organ prolapse beyond the plane of the hymen

• Concurrent use of intra-vaginal pessary or other device

• Anal or pelvic malignancy within last 5 years

• History of pelvic irradiation for cancer

• Other significant medical or lifestyle factors that could confound the interpretation of the primary endpoint or increase subject risk

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States	35233
2	Massachusetts General Hospital (MGH)	Boston	Massachusetts	United States	02114
3	University of New Mexico	Albuquerque	New Mexico	United States	87131
4	University of North Carolina	Raleigh	North Carolina	United States	27607
5	Christ Hospital	Cincinnati	Ohio	United States	45219
6	University of Oklahoma	Oklahoma City	Oklahoma	United States	73104
7	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
8	Brown University (WIHRI)	Providence	Rhode Island	United States	02903
9	Houston Methodist	Houston	Texas	United States	77030
10	Providence Sacred Heart	Spokane	Washington	United States	99204
11	University of Wisconsin	Madison	Wisconsin	United States	53792

Sponsors and Collaborators

• Pelvalon, Inc.

Investigators

• Principal Investigator: Holly Richter, PhD, MD, University of Alabama at Birmingham

Study Documents (Full-Text)

• Study Protocol - Feb 9, 2017
• Statistical Analysis Plan - Apr 2, 2018

More Information

Additional Information:

• A Vaginal Bowel-Control System for the Treatment of Fecal Incontinence (results of the LIFE Study)

Publications

• 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.

• Responsible Party: Pelvalon, Inc.
• ClinicalTrials.gov Identifier: NCT02428595
• Other Study ID Numbers: CA005
• First Posted: Apr 29, 2015
• Last Update Posted: Sep 24, 2019
• Last Verified: Aug 1, 2019

• Additional relevant MeSH terms: Fecal Incontinence

Study Results

Participant Flow

Arm/Group Title	All Patients
Arm/Group Description	All patients fit with the device, including patients that did not enter treatment. All subjects who completed the fitting process and entered the treatment period comprised the Intent-to-treat population. In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.
Period Title: Fitting
STARTED	137
COMPLETED	73
NOT COMPLETED	64
Period Title: Fitting
STARTED	73
COMPLETED	54
NOT COMPLETED	19

Baseline Characteristics

Arm/Group Title	All Subjects
Arm/Group Description	All subjects who completed the fitting process and entered the treatment period comprised the Intent-to-treat population. In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.
Overall Participants	73
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.3 (11.51)
Sex: Female, Male (Count of Participants)
Female	73 100%
Male	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	51 69.9%
Black	17 23.3%
Hispanic or Latino	5 6.8%
Region of Enrollment (participants) [Number]
United States	73 100%
Body Mass Index (participants) [Number]
<18.5 kg/m^2	1 1.4%
18.5 to <25 kg/m^2	23 31.5%
25 to <30 kg/m^2	27 37%
>=30 kg/m^2	22 30.1%
Previous Gynecological Surgeries/Treatments (Count of Participants)
Hysterectomy	30 41.1%
Prior prolapse surgery (excluding hysterectomy)	10 13.7%
Prior urinary incontinence surgery	10 13.7%
Gallbladder removal (Cholecystectomy)	9 12.3%
Fistula repair	1 1.4%
None of these	28 38.4%
Sexual Activity (Count of Participants)
Count of Participants [Participants]	37 50.7%
Parity (Pregnancies) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Pregnancies]	2.2 (1.1)
Menopausal Status (Count of Participants)
Pre-menopause	9 12.3%
Peri-menopause	4 5.5%
Post-menopause	60 82.2%
Lower Urinary Tract and Bowel Conditions (Count of Participants)
Urinary incontinence	22 30.1%
Overactive bladder (urinary frequency)	34 46.6%
Irritable Bowel Syndrome (IBS)	15 20.5%
Duration of Fecal Incontinence Symptoms (Count of Participants)
6 months-5 years	37 50.7%
>5 years	36 49.3%
Frequency of FI Symptoms (2 week period) (count) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [count]	14.1 (12.15)
Subjects with Fecal Urgency (Count of Participants)
Count of Participants [Participants]	53 72.6%
Parity (Median) (Pregnancies) [Median (Full Range) ]
Median (Full Range) [Pregnancies]	2.0
Frequency of FI Symptoms (2 week period) (median) (count) [Median (Full Range) ]
Median (Full Range) [count]	10.0

Outcome Measures

1. Primary Outcome

Title	Count of Treatment Responders in the Intent to Treat (ITT) Cohort
Description	Count of patients with >50% reduction in the average number of FI episodes per week as compared to baseline.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intent to Treat
Arm/Group Description	All subjects who completed the fitting process and entered the treatment period comprised the Intent-to-treat population. In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.
Measure Participants	73
Count of Participants [Participants]	53 72.6%

2. Secondary Outcome

Title	Count of Treatment Responders in the Per Protocol (PP) Population
Description	Count of patients with >50% reduction in the average number of FI episodes per week as compared to Baseline.
Time Frame	3, 6 and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Per Protocol - 3 Months	Per Protocol - 6 Months	Per Protocol - 12 Months
Arm/Group Description	Per Protocol cohort - 3 months is defined as all subjects who completed 3 months of the study without any major protocol deviations. In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.	Per Protocol cohort - 6 months is defined as all subjects who completed 6 months of the study without any major protocol deviations. In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.	Per Protocol cohort - 12 months is defined as all subjects who completed 12 months of the study without any major protocol deviations. In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.
Measure Participants	63	57	54
Count of Participants [Participants]	53 72.6%	51 NaN	51 NaN

3. Secondary Outcome

Title	Change in St. Mark's (Vaizey) Incontinence Severity Score as Compared to Baseline
Description	Change in mean scores on subject-reported outcomes related to symptom severity as reported by St. Mark's (Vaizey) Incontinence Severity Score. St. Mark's is a validated scale widely used in fecal incontinence research. The scale has a 24 point range where 0 = total fecal continence (better outcome) and 24 = total fecal incontinence (worse outcome). A reduction in the St. Mark's score is a better outcome.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Per Protocol - 12 Months
Arm/Group Description	Per Protocol cohort - 12 months is defined as all subjects who completed 12 months of the study without any major protocol deviations. In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.
Measure Participants	54
Mean (Standard Deviation) [Score on a Scale]	-6.9 (6.23)

4. Secondary Outcome

Title	Change in Fecal Incontinence Quality of Life (FIQoL) Score as Compared to Baseline
Description	Change in mean score (from Baseline) on subject-reported outcomes as reported by FIQoL (Fecal Incontinence Quality of Life) score. The FIQoL scale asks a number of Fecal Incontinence (FI) related questions. Patient responses are rated from 1 to 4 points except one question which is rated from 1 to 5 points. The questions fall into four subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. The score for each subscale is the average of the responses in that group. For depression/self-perception the subscale score is from 1.0 to 5.0. The other subscale scores are from 1.0 to 4.0. The total FIQoL score is the sum of all four subscales, ranging from 4 to 17. For each subscale and the combined score, lower values indicate worse quality of life and higher values indicate better quality of life. An increase in score as compared to Baseline is therefore a better outcome.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Per Protocol - 12 Months
Arm/Group Description	Per Protocol cohort - 12 months is defined as all subjects who completed 12 months of the study without any major protocol deviations. In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.
Measure Participants	54
Change in Lifestyle Subscale score	0.9 (0.79)
Change in Coping/Behavior Subscale score	1.1 (0.82)
Change in Depression/Self Perception Subscalescore	0.7 (0.75)
Change in Embarrassment Subscale score	1.2 (0.81)

5. Secondary Outcome

Title	Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores
Description	The Patient Global Impression of Improvement (PGI-I) is a scale which describes the patient's perception of how their symptoms have change from Baseline. The scale has a range of 7 points from 1 to 7, where 1 = very much better than Baseline and 7 = very much worse than Baseline and 4 = no change from Baseline. A score below 4 is a better outcome and a score above 4 is a worse outcome, and a score of 4 is a neutral outcome. Note that because the patient is being asked to compare their symptoms to Baseline, no data is taken for this scale at Baseline and the score is an absolute value, not a change from a previous score.
Time Frame	3, 6, 9 and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Per Protocol - 3 Months	Per Protocol - 6 Months	Per Protocol - 9 Months	Per Protocol - 12 Months
Arm/Group Description	Per Protocol cohort - 3 months is defined as all subjects who completed 3 months of the study without any major protocol deviations. In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.	Per Protocol cohort - 6 months is defined as all subjects who completed 6 months of the study without any major protocol deviations. In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.	Per Protocol cohort - 9 months is defined as all subjects who completed 9 months of the study without any major protocol deviations. In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.	Per Protocol cohort - 12 months is defined as all subjects who completed 12 months of the study without any major protocol deviations.
Measure Participants	62	58	54	54
Very Much Better	26 35.6%	26 NaN	29 NaN	29 NaN
Much Better	22 30.1%	19 NaN	16 NaN	14 NaN
A Little Better	10 13.7%	11 NaN	7 NaN	10 NaN
No Change	4 5.5%	1 NaN	2 NaN	1 NaN
A Little Worse	0 0%	1 NaN	0 NaN	0 NaN
Much Worse	0 0%	0 NaN	0 NaN	0 NaN
Very Much Worse	0 0%	0 NaN	0 NaN	0 NaN

6. Other Pre-specified Outcome

Title	Safety Endpoint - Number of Device Related Adverse Events
Description	The number of device-related adverse events and device-related serious adverse events (related defined as probably or definitely). Events are classified as occurring either during fitting (the process of identifying the correct size of the device) or during treatment (defined as the time when a patient receives their long term wear device until the completion of the study).
Time Frame	3, 6, 9 and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment	Fitting
Arm/Group Description	All subjects who completed the fitting process and entered the treatment period comprised the Intent-to-treat population. In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest.	The period of time where a patient is fitted with the device in order to determine the correct size. All patients in the Treatment group are also present in the Fitting group. Adverse events which occurred in the Treatment phase are not included here.
Measure Participants	73	137
Non-serious adverse events (device related)	44	90
Serious adverse events (device related)	0	0

Adverse Events

Time Frame	Events were collected for the full duration of study, including the fitting and treatment periods, for a total participation of 3.5-15 months (typically 13 months). For further detail, the fitting period, which occurs first, requires 2-4 weeks, but can be repeated up to 3 times, for a total of 2-12 weeks in this phase (typically 4 weeks). The treatment period, which follows the fitting period, is a minimum of 3 months and up to 12 months (typically 12 months).
Adverse Event Reporting Description	No difference in definitions. Adverse Event Categories: The majority of specific adverse events in this study occurred with very low frequency, which would not exceed common reporting thresholds. In order to provide a more accurate impression of the patient risk and to be more conservative in reporting, these low frequency events were gathered into groups by their systemic impact.
Arm/Group Title	Fitting		Treatment
Arm/Group Description	All subjects who underwent the fitting process (interacted with a device), including those who did not enter the treatment period. The fitting process involved an office visit with a pelvic exam, followed by test fittings of the device to determine the correct size. Patients who were successfully fit then took home the Trial Insert device and wore it during the 2 weeks during which they collected diary data (logging bowel movements and incontinence episodes). This trial wear period was allowed to be extended due to scheduling or if the patient chose not to use the device during their menstrual cycle. Patients who did not achieve a successful fit were allowed to change device size and repeat the trial period up to 2 additional times (for a total of 3 fitting cycles).		All subjects who were successfully fit and completed their eligibility diary and who entered the 12 month treatment period. This includes patients who did not complete treatment. In treatment, subjects wore the Eclipse Insert and inflated it 3x per day using the provided Pump. Patients could remove and reinsert the device as needed for cleaning or pelvic rest.
All Cause Mortality
	Fitting		Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/137 (0%)		0/73 (0%)
Serious Adverse Events
	Fitting		Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/137 (0%)		8/73 (11%)
Cardiac disorders
Chest Pain	0/137 (0%)	0	1/73 (1.4%)	1
Chest discomfort	0/137 (0%)	0	1/73 (1.4%)	1
Bradycardia	0/137 (0%)	0	1/73 (1.4%)	1
Musculoskeletal and connective tissue disorders
Worsening degenerative joint disease	0/137 (0%)	0	1/73 (1.4%)	1
Nervous system disorders
Acute stroke	0/137 (0%)	0	1/73 (1.4%)	1
Psychiatric disorders
Suicidal ideations	0/137 (0%)	0	1/73 (1.4%)	1
Reproductive system and breast disorders
Breast cancer	0/137 (0%)	0	2/73 (2.7%)	2
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease	0/137 (0%)	0	1/73 (1.4%)	1
Other (Not Including Serious) Adverse Events
	Fitting		Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	62/137 (45.3%)		28/73 (38.4%)
Gastrointestinal disorders
Constipation	0/137 (0%)	0	2/73 (2.7%)	2
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort	1/137 (0.7%)	1	0/73 (0%)	0
Reproductive system and breast disorders
Vaginal Mucosal Wall Injury	40/137 (29.2%)	46	10/73 (13.7%)	16
Lower Urinary Tract Issues	20/137 (14.6%)	21	7/73 (9.6%)	8
Vaginal/Pelvic Discomfort/Irritation	18/137 (13.1%)	20	11/73 (15.1%)	12
Vaginal Infections	2/137 (1.5%)	2	5/73 (6.8%)	6

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.