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

Not Applicable

Completed

• Conditions: Neurogenic Bowel
• Interventions: Device: Navina Smart

• Registration Number: NCT02979808
• Lead Sponsor: Dentsply International

Brief Summary

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

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 Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-11-07
• Study First Submitted QC: 2016-11-29
• Study First Posted: 2016-12-02
• Status Verified: 2019-12
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Last Update Submitted: 2019-12-11
• Last Update Posted: 2019-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Provision of informed consent.

2. Male or female aged 18 years or older.

3. Patient with previously confirmed chronic spinal cord injury, either:

   1. Traumatic; at any level and any completeness of injury and ASIA grade classification, or
   2. Non-traumatic; due to infection, inflammation (i.e.; transverse myelitis or ischaemic myelitis), compromised blood supply, a post-ischemic state, etc.

4. At least 3 months post spinal cord injury at time of consent.

5. NBD score ≥10, confirmed at Baseline .

6. Only TAI treatment - naïve patient (not having previously used any particular transanal irrigation system, e.g. Peristeen®).

7. Confirmed NBD refractory to conservative therapy and judged eligible for transanal irrigation as per standardised treatment pathway 18.

8. Able to handle smartphone/tablet.

Exclusion Criteria

1. 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.
2. Untreated rectal impaction.
3. Any radiotherapy to the pelvis.
4. Any current treatment with anticoagulants (not including aspirin or clopidogrel).
5. Any current treatment with long-term systemic steroid medication (not including inhalation agents and/or local topical treatment).
6. Current use of prokinetics.
7. Any prior rectal or colonic surgery (not including anal procedures >3 months ago, e.g. haemorrhoid excision).
8. Anal, rectal and/or colonic endoscopic polypectomy within the previous 4 weeks.
9. Overt or planned pregnancy.
10. Ongoing symptomatic UTI as judged by investigator.
11. Diagnosed psychiatric illness, considered as unstable by the investigator.
12. Diagnosed with MS.
13. Involvement in the planning and conduct of the study (applies to both WHC staff and staff at the study site).
14. Previous enrolment in the present study.
15. Simultaneous participation in another clinical study that may interfere with the present study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Navina Smart	Navina Smart	Navina Smart will be used during 12 months for transanal irrigation (TAI).

Primary Outcome Measures

Name	Time	Method
Change in neurogenic bowel disfunction symptoms.	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Change of QoL status	Baseline, 3-months, 12-months	To investigate the change of QoL status in the selected patient population (absolute values)
Patient satisfaction assessed through patient reported outcome (PRO) variables.	3-months and 12-months	To investigate patient perception and satisfaction of bowel management including TAI therapy and use of the Navina Smart system.
Frequency of urinary tract infection (UTI).	3-months and 12-months	Investigate frequency of UTI using patient reported outcome (PRO) variables.
Health economic analysis utilizing QoL data.	Baseline, 3-months, and 12-months.	To perform health economic analyses using QoL data (EQ-5D).
Thematic analysis of interview data.	Baseline, 3-months, and 12-months (or at end of treatment period).	To explore what influences individuals to continue with or stop using TAI for neurogenic bowel dysfunction.
Product use compliance.	3-months, 6-months, 9-months, and 12-months	Study product use compliance (is TAI still performed using the study device).
Incidence of adverse events, serious adverse events, and adverse device effects.	3-months, 6-months, 9-months, 12-months	To evaluate short- and long-term safety of the product and therapy by assessing adverse events, serious adverse events, adverse device effects.
NBD symptoms	6-months, 9-months, 12-months	To investigate NBD symptoms after 6, 9 and 12 months use of Navina Smart system
Health economic analysis utilizing patient reported outcome (PRO) variables.	Baseline, 3-months, and 12-months.	To perform health economic analyses using PRO variables.

Trial Locations

Locations (11)

Hôpital St Jacques; 🇫🇷 Nantes, Rennes, France

Montecatone Rehabilitation Institute, Università di Bologna; 🇮🇹 Imola, Bologna, Italy

Azienda Ospedaliera- Universitaria Careggi; 🇮🇹 Firenze, Florence, Italy

Sunnaas Sykehus HF; 🇳🇴 Nesoddtangen, Norway

Unidad de Lesionados Medulares Hospital Traumatología; 🇪🇸 Barcelona, Spain

Complejo Hospitalario Universitario A Coruña; 🇪🇸 Coruna, Spain

Gastrointestinal Physiology Unit, University College London Hospital; 🇬🇧 London, United Kingdom

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Neurologiska kliniken, Avd R18 Karolinska Universitetssjukhuset, Solna; 🇸🇪 Stockholm, Sweden

Zentralklinik Bad Berka Gmbh; 🇩🇪 Bad Berka, Germany

BG-Klinikum Hamburg; 🇩🇪 Hamburg, Germany