Clinical Study of Navina Smart: Patient Satisfaction & Compliance
Patients using transanal irrigation system Navina Smart showed high compliance rates and satisfaction levels, with 74% wanting to continue with the system. The system was well-tolerated and perceived as easy to use by a majority of users, providing a safe and novel approach to bowel care for patients who were unsatisfied with existing systems. Wellspect HealthCare presented this study at ICS 2017, highlighting the positive outcomes and benefits of Navina Smart in improving patient quality of life.
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Presentation Transcript
FIRST CLINICAL STUDY - NAVINA SMART Presented at ICS 2017 by V Passananti Passananti et al. J Pharm Pharmacol, 6 (2018) 380-394
Patients using transanal irrigation (TAI) Per Protocol Population Recruited Exclusions & Deviations Safety Analysis (n=31) (n=3) (n=28) (n=19) Hand function: 68% Normal 29% Bilateral impaired Conditions: 68% SCI 14% MS 7% Spina bifida 11% Other Gender & Age 17 Male 11 Female Mean age of 51 (range 24-73)
Result - Compliance & Satisfaction 14 (74%) 28 Wanted to continue with Navina Patients analyzed 19 (68%) 12 (63%) Patients on Navina Complete or adequate satisfaction 4 weeks 10 14 (74%) Compliance At baseline Not happy with TAI Wanted to continue with Navina
General perception of Navina Smart 96% (26/27) neutral, easy, very easy to handle (preparation) 67% (18/27) 27 Patients neutral, practical, very practical (usability) replied to follow-up questionnaire 67% (18/27) neutral, satisfied, very satisfied (satisfaction) 52% (14/27) felt the system saved time spent on the toilet
Conclusion Navina Smart is a safe novel transanal irrigation system It is well tolerated and satisfactory in two-thirds of patients who were unsatisfied with existing irrigation systems Use of the electronic unit of Navina Smart is perceived as easy by the majority Patients who were independent with bowel care tends to perform best
Wellspect HealthCare, Aminogatan 1, P.O. Box 14, SE-431 21 Mlndal, Sweden. Phone: +46 31 376 40 00.
