Trial Outcomes & Findings for A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women (NCT NCT02428595)

NCT ID: NCT02428595

Last Updated: 2019-09-24

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 137 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2019-09-24

Participant Flow

Participant milestones

Measure	All Patients 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.
Fitting STARTED	137
Fitting COMPLETED	73
Fitting NOT COMPLETED	64
Treatment STARTED	73
Treatment COMPLETED	54
Treatment NOT COMPLETED	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	All Subjects n=73 Participants 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.
Previous Gynecological Surgeries/Treatments Fistula repair	1 Participants n=5 Participants
Previous Gynecological Surgeries/Treatments None of these	28 Participants n=5 Participants
Sexual Activity	37 Participants n=5 Participants
Parity	2.2 Pregnancies STANDARD_DEVIATION 1.1 • n=5 Participants
Menopausal Status Pre-menopause	9 Participants n=5 Participants
Menopausal Status Peri-menopause	4 Participants n=5 Participants
Menopausal Status Post-menopause	60 Participants n=5 Participants
Lower Urinary Tract and Bowel Conditions Urinary incontinence	22 Participants n=5 Participants
Lower Urinary Tract and Bowel Conditions Overactive bladder (urinary frequency)	34 Participants n=5 Participants
Lower Urinary Tract and Bowel Conditions Irritable Bowel Syndrome (IBS)	15 Participants n=5 Participants
Duration of Fecal Incontinence Symptoms 6 months-5 years	37 Participants n=5 Participants
Duration of Fecal Incontinence Symptoms >5 years	36 Participants n=5 Participants
Frequency of FI Symptoms (2 week period)	14.1 count STANDARD_DEVIATION 12.15 • n=5 Participants
Subjects with Fecal Urgency	53 Participants n=5 Participants
Parity (Median)	2.0 Pregnancies n=5 Participants
Frequency of FI Symptoms (2 week period) (median)	10.0 count n=5 Participants
Age, Continuous	61.3 years STANDARD_DEVIATION 11.51 • n=5 Participants
Sex: Female, Male Female	73 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized White	51 Participants n=5 Participants
Race/Ethnicity, Customized Black	17 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	5 Participants n=5 Participants
Region of Enrollment United States	73 participants n=5 Participants
Body Mass Index <18.5 kg/m^2	1 participants n=5 Participants
Body Mass Index 18.5 to <25 kg/m^2	23 participants n=5 Participants
Body Mass Index 25 to <30 kg/m^2	27 participants n=5 Participants
Body Mass Index >=30 kg/m^2	22 participants n=5 Participants
Previous Gynecological Surgeries/Treatments Hysterectomy	30 Participants n=5 Participants
Previous Gynecological Surgeries/Treatments Prior prolapse surgery (excluding hysterectomy)	10 Participants n=5 Participants
Previous Gynecological Surgeries/Treatments Prior urinary incontinence surgery	10 Participants n=5 Participants
Previous Gynecological Surgeries/Treatments Gallbladder removal (Cholecystectomy)	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

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

Outcome measures

Measure	Intent to Treat n=73 Participants 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.	Per Protocol - 6 Months 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 - 12 Months 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.	Per Protocol - 12 Months Per Protocol cohort - 12 months is defined as all subjects who completed 12 months of the study without any major protocol deviations.
Count of Treatment Responders in the Intent to Treat (ITT) Cohort	53 Participants	—	—	—

SECONDARY outcome

Timeframe: 3, 6 and 12 months

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

Outcome measures

Measure	Intent to Treat n=63 Participants 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.	Per Protocol - 6 Months n=57 Participants 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 - 12 Months n=54 Participants 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.	Per Protocol - 12 Months Per Protocol cohort - 12 months is defined as all subjects who completed 12 months of the study without any major protocol deviations.
Count of Treatment Responders in the Per Protocol (PP) Population	53 Participants	51 Participants	51 Participants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intent to Treat n=54 Participants 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.	Per Protocol - 6 Months 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 - 12 Months 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.	Per Protocol - 12 Months Per Protocol cohort - 12 months is defined as all subjects who completed 12 months of the study without any major protocol deviations.
Change in St. Mark's (Vaizey) Incontinence Severity Score as Compared to Baseline	-6.9 Score on a Scale Standard Deviation 6.23	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intent to Treat n=54 Participants 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.	Per Protocol - 6 Months 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 - 12 Months 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.	Per Protocol - 12 Months Per Protocol cohort - 12 months is defined as all subjects who completed 12 months of the study without any major protocol deviations.
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	—	—	—
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	—	—	—
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	—	—	—
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 outcome

Timeframe: 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.

Outcome measures

Measure	Intent to Treat n=62 Participants 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.	Per Protocol - 6 Months n=58 Participants 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 - 12 Months n=54 Participants 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.	Per Protocol - 12 Months n=54 Participants Per Protocol cohort - 12 months is defined as all subjects who completed 12 months of the study without any major protocol deviations.
Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores Much Better	22 Participants	19 Participants	16 Participants	14 Participants
Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores No Change	4 Participants	1 Participants	2 Participants	1 Participants
Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores A Little Worse	0 Participants	1 Participants	0 Participants	0 Participants
Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores Very Much Better	26 Participants	26 Participants	29 Participants	29 Participants
Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores A Little Better	10 Participants	11 Participants	7 Participants	10 Participants
Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores Much Worse	0 Participants	0 Participants	0 Participants	0 Participants
Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores Very Much Worse	0 Participants	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Measure	Intent to Treat n=73 Participants 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.	Per Protocol - 6 Months n=137 Participants 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 - 12 Months 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.	Per Protocol - 12 Months Per Protocol cohort - 12 months is defined as all subjects who completed 12 months of the study without any major protocol deviations.
Safety Endpoint - Number of Device Related Adverse Events Non-serious adverse events (device related)	44 Count of Adverse Events	90 Count of Adverse Events	—	—
Safety Endpoint - Number of Device Related Adverse Events Serious adverse events (device related)	0 Count of Adverse Events	0 Count of Adverse Events	—	—

Adverse Events

Fitting

Serious events: 0 serious events

Other events: 62 other events

Deaths: 0 deaths

Treatment

Serious events: 8 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fitting n=137 participants at risk 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).	Treatment n=73 participants at risk 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.
Cardiac disorders Chest Pain	0.00% 0/137 • 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). 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.	1.4% 1/73 • Number of events 1 • 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). 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.
Psychiatric disorders Suicidal ideations	0.00% 0/137 • 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). 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.	1.4% 1/73 • Number of events 1 • 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). 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.
Reproductive system and breast disorders Breast cancer	0.00% 0/137 • 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). 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.	2.7% 2/73 • Number of events 2 • 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). 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.
Nervous system disorders Acute stroke	0.00% 0/137 • 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). 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.	1.4% 1/73 • Number of events 1 • 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). 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.
Cardiac disorders Chest discomfort	0.00% 0/137 • 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). 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.	1.4% 1/73 • Number of events 1 • 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). 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.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/137 • 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). 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.	1.4% 1/73 • Number of events 1 • 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). 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.
Cardiac disorders Bradycardia	0.00% 0/137 • 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). 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.	1.4% 1/73 • Number of events 1 • 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). 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.
Musculoskeletal and connective tissue disorders Worsening degenerative joint disease	0.00% 0/137 • 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). 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.	1.4% 1/73 • Number of events 1 • 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). 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.

Other adverse events

Measure	Fitting n=137 participants at risk 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).	Treatment n=73 participants at risk 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.
Reproductive system and breast disorders Vaginal Mucosal Wall Injury	29.2% 40/137 • Number of events 46 • 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). 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.	13.7% 10/73 • Number of events 16 • 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). 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.
Reproductive system and breast disorders Lower Urinary Tract Issues	14.6% 20/137 • Number of events 21 • 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). 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.	9.6% 7/73 • Number of events 8 • 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). 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.
Reproductive system and breast disorders Vaginal/Pelvic Discomfort/Irritation	13.1% 18/137 • Number of events 20 • 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). 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.	15.1% 11/73 • Number of events 12 • 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). 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.
Reproductive system and breast disorders Vaginal Infections	1.5% 2/137 • Number of events 2 • 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). 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.	6.8% 5/73 • Number of events 6 • 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). 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.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.73% 1/137 • Number of events 1 • 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). 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.	0.00% 0/73 • 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). 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.
Gastrointestinal disorders Constipation	0.00% 0/137 • 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). 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.	2.7% 2/73 • Number of events 2 • 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). 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.

Additional Information

Clinical Management

Pelvalon

Phone: 650-276-0130

Email: steve@pelvalon.com

Results disclosure agreements

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

Restriction type: GT60