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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
28
Transanal irrigation at the same frequency as subject used before enrollment.
Neurologiska kliniken, Karolinska Universitetssjukhuset Solna
Stockholm, Sweden
Gastrointestinal Physiology Unit, University College London Hospital
London, United Kingdom
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
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
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
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
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