Neurogenic Bowel
Conditions
Brief summary
This study is designed as an open, prospective, single arm, multicenter study in order to investigate patient satisfaction, perception and compliance for the novel Navina Smart, a transanal irrigation (TAI) system. Approximately 30 male and female subjects who are currently practicing TAI, will be followed during a 4-week period of use of Navina Smart. Observational data on satisfaction, perception, compliance, bowel regimen, TAI therapy and TAI frequency will be collected via patient reported outcome (PRO) questionnaires.
Interventions
DEVICENavina Smart
Transanal irrigation at the same frequency as subject used before enrollment.
Sponsors
Wellspect HealthCare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provision of informed consent 2. Males and females, aged 18 years and over 3. Practice TAI since at least 2 months and at least two times per week 4. Able to read and fill out a paper PRO questionnaire as judged by the principal investigator or a sub-investigator
Exclusion criteria
1. Any confirmed or suspected diagnosis of anal or rectal stenosis, active inflammatory bowel disease, acute diverticulitis, severe diverticulosis, colorectal cancer, ischemic colitis, history of life-threatening autonomic dysreflexia, bleeding disorders, unspecified peri-anal conditions 2. Untreated rectal impaction 3. Any radiotherapy to the pelvis 4. Any current treatment with anticoagulants (not including aspirin or clopidogrel) 5. Any current treatment with long-term systemic steroid medication (not including inhalation agents and/ or local topical treatment) 6. Any prior rectal or colonic surgery (not including anal procedures \>3 months ago, e.g. haemorrhoid excision) 7. Anal, rectal and/or colonic endoscopic polypectomy within the previous 4 weeks 8. Overt or planned pregnancy 9. Ongoing symptomatic urinary tract infection as judged by the principal investigator or a sub-investigator 10. Diagnosed psychiatric illness, considered as unstable by the principal investigator or a sub-investigator 11. Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site) 12. Previous enrolment in the present study 13. Participation in another clinical study within the last 30 days that may interfere with the present study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire Measuring Subjects' Satisfaction of Navina Smart | 4 weeks | 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? |
| Questionnaire Measuring Subjects' Perception of Navina Smart | 4 weeks | 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? |
| Questionnaire Measuring Subjects' Compliance of Navina Smart | 4 weeks | 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? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AEs), Adverse Device Effects (ADEs), Serious Adverse Events (SAEs) Related to Navina Smart | 4 weeks | Total numbers and types of AEs, ADEs and SAEs observed by the study staff or spontaneously reported from the patient. |
Countries
Sweden, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | Navina Smart |
|---|---|
| Age, Continuous | 53.17 years |
| Bowel Management at Baseline - Satisfaction Neutral | 7 Participants |
| Bowel Management at Baseline - Satisfaction Not Satisfied - Not satisfied at all | 11 Participants |
| Bowel Management at Baseline - Satisfaction Satisfied - Completely satisfied | 10 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 17 Participants |
| TAI therapy at Baseline Other | 0 Participants |
| TAI therapy at Baseline Peristeen | 28 Participants |
| Time spent bowel management at Baseline | 54.90 minutes |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
Questionnaire Measuring Subjects' Compliance of Navina Smart
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?
Time frame: 4 weeks
Population: Intention To Treat Analysis Set
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Navina Smart | Questionnaire Measuring Subjects' Compliance of Navina Smart | Answer missing | 0 Participants |
| Navina Smart | Questionnaire Measuring Subjects' Compliance of Navina Smart | Yes | 19 Participants |
| Navina Smart | Questionnaire Measuring Subjects' Compliance of Navina Smart | No | 9 Participants |
Primary
Questionnaire Measuring Subjects' Perception of Navina Smart
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?
Time frame: 4 weeks
Population: Intention To Treat Analysis Set
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Navina Smart | Questionnaire Measuring Subjects' Perception of Navina Smart | Answer missing | 1 Participants |
| Navina Smart | Questionnaire Measuring Subjects' Perception of Navina Smart | Neutral, satisfied or very satisfied with Navina | 18 Participants |
| Navina Smart | Questionnaire Measuring Subjects' Perception of Navina Smart | Not satisfied with Navina | 9 Participants |
Primary
Questionnaire Measuring Subjects' Satisfaction of Navina Smart
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?
Time frame: 4 weeks
Population: Intention To Treat Analysis Set
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Navina Smart | Questionnaire Measuring Subjects' Satisfaction of Navina Smart | Answer missing | 1 Participants |
| Navina Smart | Questionnaire Measuring Subjects' Satisfaction of Navina Smart | Yes | 14 Participants |
| Navina Smart | Questionnaire Measuring Subjects' Satisfaction of Navina Smart | No | 13 Participants |
Secondary
Adverse Events (AEs), Adverse Device Effects (ADEs), Serious Adverse Events (SAEs) Related to Navina Smart
Total numbers and types of AEs, ADEs and SAEs observed by the study staff or spontaneously reported from the patient.
Time frame: 4 weeks
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Navina Smart | Adverse Events (AEs), Adverse Device Effects (ADEs), Serious Adverse Events (SAEs) Related to Navina Smart | 3 number of events |