This study is designed as an open, prospective, non-controlled, qualitative, multicentre study of a novel transanal irrigation system performed in a population of 150 subjects suffering from spinal cord injury and confirmed neurological bowel dysfunction. The study is expected to last for a total of 1 year (treatment period) with a planned 12- month recruitment period and three scheduled site visits.
This study will be conducted in multiple countries, all outside of the United States. The study is approved by oversight authorities in the United Kingdom, Germany, Spain, Sweden, Denmark, Norway, France, and Italy
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
150
Subjects treatment-naïve to transanal irrigation (TAI). Frequency of TAI will be tailored to each subject.
Aarhus University Hospital
Aarhus, Denmark
Hôpital St Jacques
Nantes, Rennes, France
Zentralklinik Bad Berka Gmbh
Bad Berka, Germany
Change in neurogenic bowel disfunction symptoms.
1\. The primary objective of this study is to evaluate change in neurogenic bowel dysfunction symptoms between baseline and 3 months use of the Navina™ Smart system, as measured by a patient friendly version of the validated instrument NBD Score.
Time frame: 3 months
Change of QoL status
To investigate the change of QoL status in the selected patient population (absolute values)
Time frame: Baseline, 3-months, 12-months
NBD symptoms
To investigate NBD symptoms after 6, 9 and 12 months use of Navina Smart system
Time frame: 6-months, 9-months, 12-months
Product use compliance.
Study product use compliance (is TAI still performed using the study device).
Time frame: 3-months, 6-months, 9-months, and 12-months
Patient satisfaction assessed through patient reported outcome (PRO) variables.
To investigate patient perception and satisfaction of bowel management including TAI therapy and use of the Navina Smart system.
Time frame: 3-months and 12-months
Frequency of urinary tract infection (UTI).
Investigate frequency of UTI using patient reported outcome (PRO) variables.
Time frame: 3-months and 12-months
Health economic analysis utilizing QoL data.
To perform health economic analyses using QoL data (EQ-5D).
Time frame: Baseline, 3-months, and 12-months.
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BG-Klinikum Hamburg
Hamburg, Germany
Montecatone Rehabilitation Institute, Università di Bologna
Imola, Bologna, Italy
Azienda Ospedaliera- Universitaria Careggi
Florence, Florence, Italy
Sunnaas Sykehus HF
Nesoddtangen, Norway
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain
Unidad de Lesionados Medulares Hospital Traumatología
Barcelona, Spain
Neurologiska kliniken, Avd R18 Karolinska Universitetssjukhuset, Solna
Stockholm, Sweden
...and 1 more locations
Health economic analysis utilizing patient reported outcome (PRO) variables.
To perform health economic analyses using PRO variables.
Time frame: Baseline, 3-months, and 12-months.
Thematic analysis of interview data.
To understand individual experience of initiating and using TAI for neurogenic bowel dysfunction.
Time frame: Baseline, 3-months, and 12-months (or at end of treatment period).
Thematic analysis of interview data.
To explore individual perceptions of using TAI compared with other conservative treatments for neurogenic bowel dysfunction.
Time frame: Baseline, 3-months, and 12-months (or at end of treatment period).
Thematic analysis of interview data.
To explore what influences individuals to continue with or stop using TAI for neurogenic bowel dysfunction.
Time frame: Baseline, 3-months, and 12-months (or at end of treatment period).
Incidence of adverse events, serious adverse events, and adverse device effects.
To evaluate short- and long-term safety of the product and therapy by assessing adverse events, serious adverse events, adverse device effects.
Time frame: 3-months, 6-months, 9-months, 12-months