An Open, Qualitative, Prospective, Multicenter Trial of a Novel Transanal Irrigation System in Spinal Cord Injured Patients.

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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An Open, Qualitative, Prospective, Multicenter Trial of a Novel Transanal Irrigation System in Spinal Cord Injured Patients.

Conditions
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Neurogenic Bowel

Intervention / Treatment
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* Device: Navina Smart


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent. Male or female aged 18 years or older. Patient with previously confirmed chronic spinal cord injury, either: Traumatic; at any level and any completeness of injury and ASIA grade classification, or Non-traumatic; due to infection, inflammation (i.e.; transverse myelitis or ischaemic myelitis), compromised blood supply, a post-ischemic state, etc. At least 3 months post spinal cord injury at time of consent. NBD score ≥10, confirmed at Baseline . Only TAI treatment - naïve patient (not having previously used any particular transanal irrigation system, e.g. Peristeen®). Confirmed NBD refractory to conservative therapy and judged eligible for transanal irrigation as per standardised treatment pathway 18. Able to handle smartphone/tablet. 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). Current use of prokinetics. 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 UTI as judged by investigator. Diagnosed psychiatric illness, considered as unstable by the investigator. Diagnosed with MS. Involvement in the planning and conduct of the study (applies to both WHC staff and staff at the study site). Previous enrolment in the present study. Simultaneous participation in another clinical study that may interfere with the present study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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 12 months for transanal irrigation (TAI). | Device: Navina Smart<br>* Subjects treatment-naïve to transanal irrigation (TAI). Frequency of TAI will be tailored to each subject.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of QoL status | To investigate the change of QoL status in the selected patient population (absolute values) | Baseline, 3-months, 12-months | 
| NBD symptoms | To investigate NBD symptoms after 6, 9 and 12 months use of Navina Smart system | 6-months, 9-months, 12-months | 
| Product use compliance. | Study product use compliance (is TAI still performed using the study device). | 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. | 3-months and 12-months | 
| Frequency of urinary tract infection (UTI). | Investigate frequency of UTI using patient reported outcome (PRO) variables. | 3-months and 12-months | 
| Health economic analysis utilizing QoL data. | To perform health economic analyses using QoL data (EQ-5D). | Baseline, 3-months, and 12-months. | 
| Health economic analysis utilizing patient reported outcome (PRO) variables. | To perform health economic analyses using PRO variables. | Baseline, 3-months, and 12-months. | 
| Thematic analysis of interview data. | To understand individual experience of initiating and using TAI for neurogenic bowel dysfunction. | 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. | 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. | 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. | 3-months, 6-months, 9-months, 12-months |