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

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ClinicalTrials.gov Identifier: NCT02979808
Recruitment Status : Recruiting
First Posted : December 2, 2016
Last Update Posted : January 12, 2018
Sponsor:
Collaborator:
Wellspect HealthCare
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Neurogenic Bowel Device: Navina Smart Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Open, Qualitative, Prospective, Multicenter Trial of a Novel Transanal Irrigation System in Spinal Cord Injured Patients.
Study Start Date : October 2016
Estimated Primary Completion Date : October 2019

Arm Intervention/treatment
Experimental: Navina Smart
Navina Smart will be used during 12 months for transanal irrigation (TAI).
Device: Navina Smart
Subjects treatment-naïve to transanal irrigation (TAI). Frequency of TAI will be tailored to each subject.




Primary Outcome Measures :
  1. Change in neurogenic bowel disfunction symptoms. [ Time Frame: 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 :
  1. Change of QoL status [ Time Frame: Baseline, 3-months, 12-months ]
    To investigate the change of QoL status in the selected patient population (absolute values)

  2. NBD symptoms [ Time Frame: 6-months, 9-months, 12-months ]
    To investigate NBD symptoms after 6, 9 and 12 months use of Navina Smart system

  3. Product use compliance. [ Time Frame: 3-months, 6-months, 9-months, and 12-months ]
    Study product use compliance (is TAI still performed using the study device).

  4. Patient satisfaction assessed through patient reported outcome (PRO) variables. [ Time Frame: 3-months and 12-months ]
    To investigate patient perception and satisfaction of bowel management including TAI therapy and use of the Navina Smart system.

  5. Frequency of urinary tract infection (UTI). [ Time Frame: 3-months and 12-months ]
    Investigate frequency of UTI using patient reported outcome (PRO) variables.

  6. Health economic analysis utilizing QoL data. [ Time Frame: Baseline, 3-months, and 12-months. ]
    To perform health economic analyses using QoL data (EQ-5D).

  7. Health economic analysis utilizing patient reported outcome (PRO) variables. [ Time Frame: Baseline, 3-months, and 12-months. ]
    To perform health economic analyses using PRO variables.

  8. Thematic analysis of interview data. [ Time Frame: Baseline, 3-months, and 12-months (or at end of treatment period). ]
    To understand individual experience of initiating and using TAI for neurogenic bowel dysfunction.

  9. Thematic analysis of interview data. [ Time Frame: Baseline, 3-months, and 12-months (or at end of treatment period). ]
    To explore individual perceptions of using TAI compared with other conservative treatments for neurogenic bowel dysfunction.

  10. Thematic analysis of interview data. [ Time Frame: 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.

  11. Incidence of adverse events, serious adverse events, and adverse device effects. [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02979808


Contacts
Contact: Susanne Lindholm +46 31 376 45 03 Susanne.lindholm@wellspect.com
Contact: Anton Emmanuel, Dr. a.emmanuel@ucl.ac.uk

Locations
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Peter Christensen, Prof.       petchris@rm.dk   
France
Hôpital St Jacques Recruiting
Nantes, Rennes, France, 44093
Contact: Brigitte Perrouin-Verbe, Prof.       brigitte.perrouinverbe@chu-nantes.fr   
Germany
Zentralklinik Bad Berka Gmbh Recruiting
Bad Berka, Germany, 99437
Contact: Ines Kurze, Dr.       ines.kurze@zentralklinik.de   
BG-Klinikum Hamburg Recruiting
Hamburg, Germany, 21033
Contact: Ralf Bothig, Dr.         
Italy
Montecatone Rehabilitation Institute, Università di Bologna Recruiting
Imola, Bologna, Italy, 40026
Contact: Gabriele Bazzocchi, Prof.       gabriele.bazzocchi@unibo.it   
Contact: Gabriele Bazzocchi, Prof.       bazzocchi@montecatone.com   
Azienda Ospedaliera- Universitaria Careggi Recruiting
Firenze, Florence, Italy, 50134
Contact: Giulio Del Popolo, Dr.       delpopolog@aou-careggi.toscana.it   
Norway
Sunnaas Sykehus HF Recruiting
Nesoddtangen, Norway, 1450
Contact: Thomas Glott, Dr.       thomas.glott@sunnaas.no   
Spain
Unidad de Lesionados Medulares Hospital Traumatología Recruiting
Barcelona, Spain, 08035
Contact: Gonzalez Viejo, Dr.       maglezviejo@gmail.com   
Complejo Hospitalario Universitario A Coruña Recruiting
Coruna, Spain, 15006
Contact: Maria E Ferreiro, Dr.       MA.Elena.Ferreiro.Velasco@sergas.es   
Sweden
Neurologiska kliniken, Avd R18 Karolinska Universitetssjukhuset, Solna Recruiting
Stockholm, Sweden, 171 76
Contact: Claes Hultling, Prof.       claes@spinalis.se   
United Kingdom
Gastrointestinal Physiology Unit, University College London Hospital Recruiting
London, United Kingdom, NW1 2BU
Contact: Anton Emmanuel, Prof.       a.emmanuel@ucl.ac.uk   
Sponsors and Collaborators
Dentsply International
Wellspect HealthCare

Responsible Party: Dentsply International
ClinicalTrials.gov Identifier: NCT02979808     History of Changes
Other Study ID Numbers: NAV-0001
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Neurogenic Bowel
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases