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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02428595
Recruitment Status : Completed
First Posted : April 29, 2015
Results First Posted : September 24, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Pelvalon, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Fecal Incontinence
Intervention Device: Eclipse™ System
Enrollment 137
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Patients
Hide 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: Treatment
Started 73
Completed 54
Not Completed 19
Arm/Group Title All Subjects
Hide 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 Number of Baseline Participants 73
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 73 participants
61.3  (11.51)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants
Female
73
 100.0%
Male
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants
White
51
  69.9%
Black
17
  23.3%
Hispanic or Latino
5
   6.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 73 participants
73
Body Mass Index  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 73 participants
<18.5 kg/m^2 1
18.5 to <25 kg/m^2 23
25 to <30 kg/m^2 27
>=30 kg/m^2 22
Previous Gynecological Surgeries/Treatments  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants
37
  50.7%
Parity  
Mean (Standard Deviation)
Unit of measure:  Pregnancies
Number Analyzed 73 participants
2.2  (1.1)
Menopausal Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants
Pre-menopause
9
  12.3%
Peri-menopause
4
   5.5%
Post-menopause
60
  82.2%
Lower Urinary Tract and Bowel Conditions  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants
6 months-5 years
37
  50.7%
>5 years
36
  49.3%
Frequency of FI Symptoms (2 week period)  
Mean (Standard Deviation)
Unit of measure:  Count
Number Analyzed 73 participants
14.1  (12.15)
Subjects with Fecal Urgency  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants
53
  72.6%
Parity (Median)  
Median (Full Range)
Unit of measure:  Pregnancies
Number Analyzed 73 participants
2.0
(0 to 6)
Frequency of FI Symptoms (2 week period) (median)  
Median (Full Range)
Unit of measure:  Count
Number Analyzed 73 participants
10.0
(4 to 83)
1.Primary Outcome
Title Count of Treatment Responders in the Intent to Treat (ITT) Cohort
Hide Description Count of patients with >50% reduction in the average number of FI episodes per week as compared to baseline.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intent to Treat
Hide 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 Number of Participants Analyzed 73
Measure Type: Count of Participants
Unit of Measure: Participants
53
  72.6%
2.Secondary Outcome
Title Count of Treatment Responders in the Per Protocol (PP) Population
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Per Protocol - 3 Months Per Protocol - 6 Months Per Protocol - 12 Months
Hide 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.
Overall Number of Participants Analyzed 63 57 54
Measure Type: Count of Participants
Unit of Measure: Participants
53
  84.1%
51
  89.5%
51
  94.4%
3.Secondary Outcome
Title Change in St. Mark's (Vaizey) Incontinence Severity Score as Compared to Baseline
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Per Protocol - 12 Months
Hide 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.
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Per Protocol - 12 Months
Hide 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.
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: Score on a scale
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Per Protocol - 3 Months Per Protocol - 6 Months Per Protocol - 9 Months Per Protocol - 12 Months
Hide 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.
Overall Number of Participants Analyzed 62 58 54 54
Measure Type: Count of Participants
Unit of Measure: Participants
Very Much Better
26
  41.9%
26
  44.8%
29
  53.7%
29
  53.7%
Much Better
22
  35.5%
19
  32.8%
16
  29.6%
14
  25.9%
A Little Better
10
  16.1%
11
  19.0%
7
  13.0%
10
  18.5%
No Change
4
   6.5%
1
   1.7%
2
   3.7%
1
   1.9%
A Little Worse
0
   0.0%
1
   1.7%
0
   0.0%
0
   0.0%
Much Worse
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Very Much Worse
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6.Other Pre-specified Outcome
Title Safety Endpoint - Number of Device Related Adverse Events
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Fitting
Hide 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.
Overall Number of Participants Analyzed 73 137
Measure Type: Number
Unit of Measure: Count of Adverse Events
Non-serious adverse events (device related) 44 90
Serious adverse events (device related) 0 0
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
Hide 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 (%) Affected / at Risk (%)
Total   0/137 (0.00%)      0/73 (0.00%)    
Hide Serious Adverse Events
Fitting Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/137 (0.00%)      8/73 (10.96%)    
Cardiac disorders     
Chest Pain  [1]  0/137 (0.00%)  0 1/73 (1.37%)  1
Chest discomfort  [2]  0/137 (0.00%)  0 1/73 (1.37%)  1
Bradycardia  [3]  0/137 (0.00%)  0 1/73 (1.37%)  1
Musculoskeletal and connective tissue disorders     
Worsening degenerative joint disease  [4]  0/137 (0.00%)  0 1/73 (1.37%)  1
Nervous system disorders     
Acute stroke  [3]  0/137 (0.00%)  0 1/73 (1.37%)  1
Psychiatric disorders     
Suicidal ideations  [3]  0/137 (0.00%)  0 1/73 (1.37%)  1
Reproductive system and breast disorders     
Breast cancer  [3]  0/137 (0.00%)  0 2/73 (2.74%)  2
Respiratory, thoracic and mediastinal disorders     
Interstitial lung disease  [5]  0/137 (0.00%)  0 1/73 (1.37%)  1
Indicates events were collected by systematic assessment
[1]
Not device related. Patient hospitalized for chest pain, underwent heart catheterization.
[2]
Not device related. Worsening dyspnea on exertion. Cardiac catheter and stent placement. History of coronary artery disease.
[3]
Not device related.
[4]
Not device related. Worsening degenerative joint disease of bilateral hips.
[5]
Not device related. History of interstitial lung disease.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fitting Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   62/137 (45.26%)      28/73 (38.36%)    
Gastrointestinal disorders     
Constipation  [1]  0/137 (0.00%)  0 2/73 (2.74%)  2
Musculoskeletal and connective tissue disorders     
Musculoskeletal discomfort  [2]  1/137 (0.73%)  1 0/73 (0.00%)  0
Reproductive system and breast disorders     
Vaginal Mucosal Wall Injury  [3]  40/137 (29.20%)  46 10/73 (13.70%)  16
Lower Urinary Tract Issues  [4]  20/137 (14.60%)  21 7/73 (9.59%)  8
Vaginal/Pelvic Discomfort/Irritation  [5]  18/137 (13.14%)  20 11/73 (15.07%)  12
Vaginal Infections  [6]  2/137 (1.46%)  2 5/73 (6.85%)  6
Indicates events were collected by systematic assessment
[1]
Constipation
[2]
Leg pain.
[3]
Abrasion, bleeding, erythema, petechia, ecchymosis, hyperemia, or erosion of vaginal tissue apparent during pelvic examination.
[4]
New or increased urinary incontinence or voiding difficulty or urinary frequency, urinary tract infections, or dysuria.
[5]
Vaginal/Pelvic discomfort, pain, irritation, discharge, odor, burning sensation, or itching.
[6]
Yeast infection of the vagina or unspecified vaginitis. Does not include systemic yeast infections or infections of other areas that do not affect the vagina.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Management
Organization: Pelvalon
Phone: 650-276-0130
EMail: steve@pelvalon.com
Layout table for additonal information
Responsible Party: Pelvalon, Inc.
ClinicalTrials.gov Identifier: NCT02428595    
Other Study ID Numbers: CA005
First Submitted: April 18, 2015
First Posted: April 29, 2015
Results First Submitted: May 9, 2019
Results First Posted: September 24, 2019
Last Update Posted: September 24, 2019