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

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Navina Smart	Navina Smart	Navina Smart will be used, during 4 weeks, for transanal irrigation (TAI).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Locations (2): Gastrointestinal Physiology Unit, University College London Hospital
🇬🇧
London, United Kingdom
Neurologiska kliniken, Karolinska Universitetssjukhuset Solna
🇸🇪
Stockholm, Sweden