Trial Outcomes & Findings for Evaluation of a Novel Electronic Transanal Irrigation System

Results Overview

PRO Questionnaire, completed by each subject after 4 weeks of using Navina Smart, collecting data on subject's assessment of satisfaction when using the study device. Satisfaction was assessed in a range of ways through different questions to be answered by each subject. For example each subject received the question "If possible, would you consider continuing using the Navina Smart system?"

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

4 weeks

Results posted on

2023-01-26

Participant Flow

Participant milestones

Participant milestones
Measure	Navina Smart Navina Smart will be used, during 4 weeks, for transanal irrigation (TAI). Navina Smart: Transanal irrigation at the same frequency as subject used before enrollment.
Overall Study STARTED	28
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data missing for 4 subjects, no response received

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Navina Smart n=28 Participants Navina Smart will be used, during 4 weeks, for transanal irrigation (TAI). Navina Smart: Transanal irrigation at the same frequency as subject used before enrollment.
Age, Continuous	53.17 years n=28 Participants
Sex: Female, Male Female	11 Participants n=28 Participants
Sex: Female, Male Male	17 Participants n=28 Participants
Bowel Management at Baseline - Satisfaction Not Satisfied - Not satisfied at all	11 Participants n=28 Participants
Bowel Management at Baseline - Satisfaction Neutral	7 Participants n=28 Participants
Bowel Management at Baseline - Satisfaction Satisfied - Completely satisfied	10 Participants n=28 Participants
TAI therapy at Baseline Peristeen	28 Participants n=28 Participants
TAI therapy at Baseline Other	0 Participants n=28 Participants
Time spent bowel management at Baseline	54.90 minutes n=24 Participants • Data missing for 4 subjects, no response received

PRIMARY outcome

Timeframe: 4 weeks

Population: Intention To Treat Analysis Set

PRO Questionnaire, completed by each subject after 4 weeks of using Navina Smart, collecting data on subject's assessment of satisfaction when using the study device. Satisfaction was assessed in a range of ways through different questions to be answered by each subject. For example each subject received the question "If possible, would you consider continuing using the Navina Smart system?"

Outcome measures

Outcome measures
Measure	Navina Smart n=28 Participants Navina Smart will be used, during 4 weeks, for transanal irrigation (TAI). Navina Smart: Transanal irrigation at the same frequency as subject used before enrollment.
Questionnaire Measuring Subjects' Satisfaction of Navina Smart Answer missing	1 Participants
Questionnaire Measuring Subjects' Satisfaction of Navina Smart Yes	14 Participants
Questionnaire Measuring Subjects' Satisfaction of Navina Smart No	13 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Intention To Treat Analysis Set

PRO Questionnaire, completed by each subject after 4 weeks of using Navina Smart, collecting data on subject's assessment of perception when using the study device. For example, each subject answered the following question regarding perception: "How satisfied are you with the Navina Smart System?"

Outcome measures

Outcome measures
Measure	Navina Smart n=28 Participants Navina Smart will be used, during 4 weeks, for transanal irrigation (TAI). Navina Smart: Transanal irrigation at the same frequency as subject used before enrollment.
Questionnaire Measuring Subjects' Perception of Navina Smart Answer missing	1 Participants
Questionnaire Measuring Subjects' Perception of Navina Smart Neutral, satisfied or very satisfied with Navina	18 Participants
Questionnaire Measuring Subjects' Perception of Navina Smart Not satisfied with Navina	9 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Intention To Treat Analysis Set

PRO Questionnaire, completed by each subject after 4 weeks of using Navina Smart, collecting data on subject's compliance towards the study device. For example, each subject answered the following question "Did you use the Navina Smart system for 4 weeks?"

Outcome measures

Outcome measures
Measure	Navina Smart n=28 Participants Navina Smart will be used, during 4 weeks, for transanal irrigation (TAI). Navina Smart: Transanal irrigation at the same frequency as subject used before enrollment.
Questionnaire Measuring Subjects' Compliance of Navina Smart Answer missing	0 Participants
Questionnaire Measuring Subjects' Compliance of Navina Smart Yes	19 Participants
Questionnaire Measuring Subjects' Compliance of Navina Smart No	9 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Safety Analysis Set

Total numbers and types of AEs, ADEs and SAEs observed by the study staff or spontaneously reported from the patient.

Outcome measures

Outcome measures
Measure	Navina Smart n=28 Participants Navina Smart will be used, during 4 weeks, for transanal irrigation (TAI). Navina Smart: Transanal irrigation at the same frequency as subject used before enrollment.
Adverse Events (AEs), Adverse Device Effects (ADEs), Serious Adverse Events (SAEs) Related to Navina Smart	3 number of events

Adverse Events

Navina Smart

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Navina Smart n=28 participants at risk Navina Smart will be used, during 4 weeks, for transanal irrigation (TAI). Navina Smart: Transanal irrigation at the same frequency as subject used before enrollment.
Injury, poisoning and procedural complications Broke left leg	3.6% 1/28 • The safety of Navina Smart, e.g. registration of Adverse Events (AEs), Adverse Device Effects (ADEs), Serious Adverse Events (SAEs), were collected throughout the study period for 4 weeks of each participating subject.
Gastrointestinal disorders Vomiting	3.6% 1/28 • The safety of Navina Smart, e.g. registration of Adverse Events (AEs), Adverse Device Effects (ADEs), Serious Adverse Events (SAEs), were collected throughout the study period for 4 weeks of each participating subject.
Skin and subcutaneous tissue disorders Skin infection elbow	3.6% 1/28 • The safety of Navina Smart, e.g. registration of Adverse Events (AEs), Adverse Device Effects (ADEs), Serious Adverse Events (SAEs), were collected throughout the study period for 4 weeks of each participating subject.

Additional Information

Head of Medical Affairs, Markus Wittebo

Wellspect HealthCare

Phone: +46 31 376 40 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place