Evaluation of a Novel Electronic Transanal Irrigation System - Navina™ Smart

Study Overview
=================
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.

Official Title
-----------------
Evaluation of a Novel Electronic Transanal Irrigation System - Navina™ Smart

Conditions
-----------------
Neurogenic Bowel

Intervention / Treatment
-----------------
* Device: Navina Smart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent Males and females, aged 18 years and over Practice TAI since at least 2 months and at least two times per week Able to read and fill out a paper PRO questionnaire as judged by the principal investigator or a sub-investigator Exclusion Criteria: 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 Untreated rectal impaction Any radiotherapy to the pelvis Any current treatment with anticoagulants (not including aspirin or clopidogrel) Any current treatment with long-term systemic steroid medication (not including inhalation agents and/ or local topical treatment) Any prior rectal or colonic surgery (not including anal procedures >3 months ago, e.g. haemorrhoid excision) Anal, rectal and/or colonic endoscopic polypectomy within the previous 4 weeks Overt or planned pregnancy Ongoing symptomatic urinary tract infection as judged by the principal investigator or a sub-investigator Diagnosed psychiatric illness, considered as unstable by the principal investigator or a sub-investigator Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site) Previous enrolment in the present study Participation in another clinical study within the last 30 days that may interfere with the present study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Navina Smart<br>Navina Smart will be used, during 4 weeks, for transanal irrigation (TAI). | Device: Navina Smart<br>* Transanal irrigation at the same frequency as subject used before enrollment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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? | 4 weeks | 
| 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? | 4 weeks | 
| 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? | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 weeks |