Trial Outcomes & Findings for Randomized Clinical Trial on Transanal Irrigation (NCT NCT04586634)

Results Overview

Obtained from the LARS score questionnaire on a scale from 0-42 in total score. Subscores are summed to get the total score. With 0 indicating lowest score and 42 highest score. 0-20 indicate No LARS, 21-29 minor LARS, 30-42 Major LARS.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

Total score measured per subject at study completion after 12 weeks

Results posted on

2024-07-22

Participant Flow

Participant milestones

Participant milestones
Measure	Peristeen Subjects to use newly developed Peristeen cone catherter device Peristeen cone catheter: The active intervention is the Peristeen cone catheter device. The comparator in this investigation is current standard of care for patients with LARS which is conservative bowel management.	Standard of Care subjects continue with their standard of care treatment
Overall Study STARTED	16	16
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peristeen n=15 Participants Subjects to use newly developed Peristeen cone catherter device	Standard of Care n=15 Participants Subjects continue with their standard of care treatment which is conservative bowel management.	Total n=30 Participants Total of all reporting groups
Age, Continuous	63.3 Years STANDARD_DEVIATION 12.9 • n=15 Participants	62.9 Years STANDARD_DEVIATION 10.1 • n=15 Participants	63.1 Years STANDARD_DEVIATION 11.4 • n=30 Participants
Sex: Female, Male Female	2 Participants n=15 Participants	6 Participants n=15 Participants	8 Participants n=30 Participants
Sex: Female, Male Male	13 Participants n=15 Participants	9 Participants n=15 Participants	22 Participants n=30 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment France	15 participants n=15 Participants	15 participants n=15 Participants	30 participants n=30 Participants

PRIMARY outcome

Timeframe: Total score measured per subject at study completion after 12 weeks

Population: Missing data from 1 standard of care patient

Obtained from the LARS score questionnaire on a scale from 0-42 in total score. Subscores are summed to get the total score. With 0 indicating lowest score and 42 highest score. 0-20 indicate No LARS, 21-29 minor LARS, 30-42 Major LARS.

Outcome measures

Outcome measures
Measure	Peristeen n=15 Participants Subjects to use newly developed Peristeen cone catherter device	Standard of Care n=14 Participants Subjects continue with their standard of care treatment which is conservative bowel management.
LARS Score	21.3 score on a scale Interval 14.7 to 27.8	32.2 score on a scale Interval 27.3 to 37.1

SECONDARY outcome

Timeframe: 12 weeks

Population: missing data from 1 participant in standard of care

Obtained from the LARS score questionnaire on a scale from 0-42 in total score. Subscores are summed to get the total score. With 0 indicating lowest score and 42 highest score. 0-20 indicate No LARS, 21-29 minor LARS, 30-42 Major LARS.

Outcome measures

Outcome measures
Measure	Peristeen n=15 Participants Subjects to use newly developed Peristeen cone catherter device	Standard of Care n=14 Participants Subjects continue with their standard of care treatment which is conservative bowel management.
Number of Subjects With Major LARS	5 Participants	10 Participants

SECONDARY outcome

Timeframe: 12 weeks

The FIQL scale was thus interpreted for four scales exploring different aspects of the patient's quality-of-life. the Fecal Incontinence Quality of Life Scale (FIQL) contains 29 questions, across 4 domains, lifestyle (10 questions), Coping/Behavior (9 questions), Depression/Self Perception (7 questions), Embarrassment (3 questions). Items were scored 1 (least satisfactory quality-of-life) to 4 (most satisfactory quality-of-life) Results are reported as a Scale score which is the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale).

Outcome measures

Outcome measures
Measure	Peristeen n=15 Participants Subjects to use newly developed Peristeen cone catherter device	Standard of Care n=15 Participants Subjects continue with their standard of care treatment which is conservative bowel management.
FIQL Score - Scale 1 Lifestyle, Modified American Society for Colorectal Surgeons Questionnaire	3.10 score on a scale Interval 2.65 to 3.55	2.60 score on a scale Interval 2.06 to 3.15

SECONDARY outcome

Timeframe: 12 weeks

The FIQL scale was thus interpreted for four scales exploring different aspects of the patient's quality-of-life. the Fecal Incontinence Quality of Life Scale (FIQL) contains 29 questions, across 4 domains, lifestyle (10 questions), Coping/Behavior (9 questions), Depression/Self Perception (7 questions), Embarrassment (3 questions). Items were scored 1 (least satisfactory quality-of-life) to 4 (most satisfactory quality-of-life) Results are reported as a Scale score which is the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale).

Outcome measures

Outcome measures
Measure	Peristeen n=15 Participants Subjects to use newly developed Peristeen cone catherter device	Standard of Care n=15 Participants Subjects continue with their standard of care treatment which is conservative bowel management.
FIQL Score - Scale 2 Coping/Behavior, Modified American Society for Colorectal Surgeons Questionnaire	2.95 score on a scale Interval 2.55 to 3.35	2.37 score on a scale Interval 1.91 to 2.82

SECONDARY outcome

Timeframe: 12 weeks

The FIQL scale was thus interpreted for four scales exploring different aspects of the patient's quality-of-life. the Fecal Incontinence Quality of Life Scale (FIQL) contains 29 questions, across 4 domains, lifestyle (10 questions), Coping/Behavior (9 questions), Depression/Self Perception (7 questions), Embarrassment (3 questions). Items were scored 1 (least satisfactory quality-of-life) to 4 (most satisfactory quality-of-life) Results are reported as a Scale score which is the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale).

Outcome measures

Outcome measures
Measure	Peristeen n=15 Participants Subjects to use newly developed Peristeen cone catherter device	Standard of Care n=15 Participants Subjects continue with their standard of care treatment which is conservative bowel management.
FIQL Score - Scale 3 Depression/Self-perception, Modified American Society for Colorectal Surgeons Questionnaire	3.41 score on a scale Interval 2.87 to 3.95	3.23 score on a scale Interval 2.76 to 3.71

SECONDARY outcome

Timeframe: 12 weeks

The FIQL scale was thus interpreted for four scales exploring different aspects of the patient's quality-of-life. the Fecal Incontinence Quality of Life Scale (FIQL) contains 29 questions, across 4 domains, lifestyle (10 questions), Coping/Behavior (9 questions), Depression/Self Perception (7 questions), Embarrassment (3 questions). Items were scored 1 (least satisfactory quality-of-life) to 4 (most satisfactory quality-of-life) Results are reported as a Scale score which is the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale).

Outcome measures

Outcome measures
Measure	Peristeen n=15 Participants Subjects to use newly developed Peristeen cone catherter device	Standard of Care n=15 Participants Subjects continue with their standard of care treatment which is conservative bowel management.
FIQL Score - Scale 4 Embarrassment , Modified American Society For Colorectal Surgeons Questionnaire	2.98 score on a scale Interval 2.57 to 3.38	2.76 score on a scale Interval 2.26 to 3.27

SECONDARY outcome

Timeframe: 12 weeks

Each of the five dimensions comprising the EQ-5D descriptive system (mobility, self-care, usual activates, pain/discomfort, anxiety/depression) was divided into five levels: 1. no problem 2. slight problems 3. moderate problems 4. severe problems 5. unable to/extreme problems A unique health state was defined by combining one level from each of the five dimensions. i.e. state 12345 each state referred to by a 5-digit code was mapped into a utility score. Values are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation. Values less than 0 represent health states regarded as worse than a state that is as bad as being dead. EQ-5D-5L health states are converted into a single index 'utility' score using a scoring algorithm based on public preferences. Potential values from this algorithm can range from minus scores up to 1, in this case -0.525 to 1.

Outcome measures

Outcome measures
Measure	Peristeen n=15 Participants Subjects to use newly developed Peristeen cone catherter device	Standard of Care n=15 Participants Subjects continue with their standard of care treatment which is conservative bowel management.
EQ-5D-5L - Utility Score	0.92 score on a scale Interval 0.86 to 0.97	0.88 score on a scale Interval 0.81 to 0.95

SECONDARY outcome

Timeframe: 12 weeks

The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. The VAS scale is from 0 to 100 with 0 indicating worst health and 100 best health possible.

Outcome measures

Outcome measures
Measure	Peristeen n=15 Participants Subjects to use newly developed Peristeen cone catherter device	Standard of Care n=15 Participants Subjects continue with their standard of care treatment which is conservative bowel management.
EQ-5D-5L - VAS Score	82.8 score on a scale Interval 70.2 to 95.5	71.4 score on a scale Interval 57.8 to 85.0

SECONDARY outcome

Timeframe: 12 weeks

Satisfaction with current bowel management treatment on a scale from 0 (total dissatisfaction) to 10 (perfect satisfaction)" rated on a VAS scale from 0 to 10 cm.

Outcome measures

Outcome measures
Measure	Peristeen n=15 Participants Subjects to use newly developed Peristeen cone catherter device	Standard of Care n=15 Participants Subjects continue with their standard of care treatment which is conservative bowel management.
Satisfaction With Treatment	8.6 score on a scale Interval 7.4 to 9.7	5.9 score on a scale Interval 5.1 to 8.3

Adverse Events

Peristeen

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Peristeen n=16 participants at risk Subjects to use newly developed Peristeen cone catherter device	Standard of Care n=16 participants at risk Subjects continue with their standard of care treatment which is conservative bowel management.
Gastrointestinal disorders Mild Abdominal Pain	31.2% 5/16 • Number of events 7 • 12 weeks Investigator Assessed at visits and phone calls	0.00% 0/16 • 12 weeks Investigator Assessed at visits and phone calls

Additional Information

Director of Clinical Strategy

Coloplast

Phone: +4549111111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place