Fecal Incontinence
Conditions
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.
Interventions
DEVICEEclipse™ 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.
Sponsors
Pelvalon, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Subjects 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. | 73 |
| Total | 73 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 61.3 years STANDARD_DEVIATION 11.51 |
| Body Mass Index <18.5 kg/m^2 | 1 participants |
| Body Mass Index 18.5 to <25 kg/m^2 | 23 participants |
| Body Mass Index 25 to <30 kg/m^2 | 27 participants |
| Body Mass Index >=30 kg/m^2 | 22 participants |
| Duration of Fecal Incontinence Symptoms >5 years | 36 Participants |
| Duration of Fecal Incontinence Symptoms 6 months-5 years | 37 Participants |
| Frequency of FI Symptoms (2 week period) | 14.1 count STANDARD_DEVIATION 12.15 |
| Frequency of FI Symptoms (2 week period) (median) | 10.0 count |
| Lower Urinary Tract and Bowel Conditions Irritable Bowel Syndrome (IBS) | 15 Participants |
| Lower Urinary Tract and Bowel Conditions Overactive bladder (urinary frequency) | 34 Participants |
| Lower Urinary Tract and Bowel Conditions Urinary incontinence | 22 Participants |
| Menopausal Status Peri-menopause | 4 Participants |
| Menopausal Status Post-menopause | 60 Participants |
| Menopausal Status Pre-menopause | 9 Participants |
| Parity | 2.2 Pregnancies STANDARD_DEVIATION 1.1 |
| Parity (Median) | 2.0 Pregnancies |
| Previous Gynecological Surgeries/Treatments Fistula repair | 1 Participants |
| Previous Gynecological Surgeries/Treatments Gallbladder removal (Cholecystectomy) | 9 Participants |
| Previous Gynecological Surgeries/Treatments Hysterectomy | 30 Participants |
| Previous Gynecological Surgeries/Treatments None of these | 28 Participants |
| Previous Gynecological Surgeries/Treatments Prior prolapse surgery (excluding hysterectomy) | 10 Participants |
| Previous Gynecological Surgeries/Treatments Prior urinary incontinence surgery | 10 Participants |
| Race/Ethnicity, Customized Black | 17 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 5 Participants |
| Race/Ethnicity, Customized White | 51 Participants |
| Region of Enrollment United States | 73 participants |
| Sex: Female, Male Female | 73 Participants |
| Sex: Female, Male Male | 0 Participants |
| Sexual Activity | 37 Participants |
| Subjects with Fecal Urgency | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 137 | 0 / 73 |
| other Total, other adverse events | 62 / 137 | 28 / 73 |
| serious Total, serious adverse events | 0 / 137 | 8 / 73 |
Outcome results
Primary
Count of Treatment Responders in the Intent to Treat (ITT) Cohort
Count of patients with \>50% reduction in the average number of FI episodes per week as compared to baseline.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intent to Treat | Count of Treatment Responders in the Intent to Treat (ITT) Cohort | 53 Participants |
Secondary
Change in Fecal Incontinence Quality of Life (FIQoL) Score as Compared to Baseline
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intent to Treat | Change in Fecal Incontinence Quality of Life (FIQoL) Score as Compared to Baseline | Change in Lifestyle Subscale score | 0.9 Score on a scale | Standard Deviation 0.79 |
| Intent to Treat | Change in Fecal Incontinence Quality of Life (FIQoL) Score as Compared to Baseline | Change in Coping/Behavior Subscale score | 1.1 Score on a scale | Standard Deviation 0.82 |
| Intent to Treat | Change in Fecal Incontinence Quality of Life (FIQoL) Score as Compared to Baseline | Change in Depression/Self Perception Subscalescore | 0.7 Score on a scale | Standard Deviation 0.75 |
| Intent to Treat | Change in Fecal Incontinence Quality of Life (FIQoL) Score as Compared to Baseline | Change in Embarrassment Subscale score | 1.2 Score on a scale | Standard Deviation 0.81 |
Secondary
Change in St. Mark's (Vaizey) Incontinence Severity Score as Compared to Baseline
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intent to Treat | Change in St. Mark's (Vaizey) Incontinence Severity Score as Compared to Baseline | -6.9 Score on a Scale | Standard Deviation 6.23 |
Secondary
Count of Treatment Responders in the Per Protocol (PP) Population
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intent to Treat | Count of Treatment Responders in the Per Protocol (PP) Population | 53 Participants |
| Per Protocol - 6 Months | Count of Treatment Responders in the Per Protocol (PP) Population | 51 Participants |
| Per Protocol - 12 Months | Count of Treatment Responders in the Per Protocol (PP) Population | 51 Participants |
Secondary
Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intent to Treat | Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | A Little Worse | 0 Participants |
| Intent to Treat | Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | Very Much Worse | 0 Participants |
| Intent to Treat | Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | Much Better | 22 Participants |
| Intent to Treat | Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | No Change | 4 Participants |
| Intent to Treat | Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | A Little Better | 10 Participants |
| Intent to Treat | Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | Very Much Better | 26 Participants |
| Intent to Treat | Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | Much Worse | 0 Participants |
| Per Protocol - 6 Months | Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | Very Much Better | 26 Participants |
| Per Protocol - 6 Months | Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | Much Better | 19 Participants |
| Per Protocol - 6 Months | Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | A Little Better | 11 Participants |
| Per Protocol - 6 Months | Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | No Change | 1 Participants |
| Per Protocol - 6 Months | Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | A Little Worse | 1 Participants |
| Per Protocol - 6 Months | Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | Much Worse | 0 Participants |
| Per Protocol - 6 Months | Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | Very Much Worse | 0 Participants |
| Per Protocol - 12 Months | Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | Very Much Worse | 0 Participants |
| Per Protocol - 12 Months | Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | A Little Worse | 0 Participants |
| Per Protocol - 12 Months | Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | No Change | 2 Participants |
| Per Protocol - 12 Months | Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | Very Much Better | 29 Participants |
| Per Protocol - 12 Months | Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | Much Worse | 0 Participants |
| Per Protocol - 12 Months | Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | Much Better | 16 Participants |
| Per Protocol - 12 Months | Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | A Little Better | 7 Participants |
| Per Protocol - 12 Months | Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | Much Better | 14 Participants |
| Per Protocol - 12 Months | Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | Much Worse | 0 Participants |
| Per Protocol - 12 Months | Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | Very Much Better | 29 Participants |
| Per Protocol - 12 Months | Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | Very Much Worse | 0 Participants |
| Per Protocol - 12 Months | Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | A Little Worse | 0 Participants |
| Per Protocol - 12 Months | Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | No Change | 1 Participants |
| Per Protocol - 12 Months | Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | A Little Better | 10 Participants |
Other Pre-specified
Safety Endpoint - Number of Device Related Adverse Events
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intent to Treat | Safety Endpoint - Number of Device Related Adverse Events | Non-serious adverse events (device related) | 44 Count of Adverse Events |
| Intent to Treat | Safety Endpoint - Number of Device Related Adverse Events | Serious adverse events (device related) | 0 Count of Adverse Events |
| Per Protocol - 6 Months | Safety Endpoint - Number of Device Related Adverse Events | Non-serious adverse events (device related) | 90 Count of Adverse Events |
| Per Protocol - 6 Months | Safety Endpoint - Number of Device Related Adverse Events | Serious adverse events (device related) | 0 Count of Adverse Events |