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

• Sponsor: Dentsply International (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02979808
• Collaborator: Wellspect HealthCare (Industry)
• Enrollment: 150
• Locations: 11
• Arm: 1
• Duration (Months): 38
• Patients Per Site: 13.6
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: N/A
• 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: Oct 1, 2016
• Actual Primary Completion Date: Dec 1, 2019
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Change of QoL status [Baseline, 3-months, 12-months]

   To investigate the change of QoL status in the selected patient population (absolute values)

2. NBD symptoms [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. [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. [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). [3-months and 12-months]

   Investigate frequency of UTI using patient reported outcome (PRO) variables.

6. Health economic analysis utilizing QoL data. [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. [Baseline, 3-months, and 12-months.]

   To perform health economic analyses using PRO variables.

8. Thematic analysis of interview data. [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. [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. [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. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

4. Traumatic; at any level and any completeness of injury and ASIA grade classification, or

5. Non-traumatic; due to infection, inflammation (i.e.; transverse myelitis or ischaemic myelitis), compromised blood supply, a post-ischemic state, etc.

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

7. NBD score ≥10, confirmed at Baseline .

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

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

10. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital	Aarhus		Denmark	8000
2	Hôpital St Jacques	Nantes	Rennes	France	44093
3	Zentralklinik Bad Berka Gmbh	Bad Berka		Germany	99437
4	BG-Klinikum Hamburg	Hamburg		Germany	21033
5	Montecatone Rehabilitation Institute, Università di Bologna	Imola	Bologna	Italy	40026
6	Azienda Ospedaliera- Universitaria Careggi	Firenze	Florence	Italy	50134
7	Sunnaas Sykehus HF	Nesoddtangen		Norway	1450
8	Unidad de Lesionados Medulares Hospital Traumatología	Barcelona		Spain	08035
9	Complejo Hospitalario Universitario A Coruña	Coruna		Spain	15006
10	Neurologiska kliniken, Avd R18 Karolinska Universitetssjukhuset, Solna	Stockholm		Sweden	171 76
11	Gastrointestinal Physiology Unit, University College London Hospital	London		United Kingdom	NW1 2BU

Sponsors and Collaborators

• Dentsply International
• Wellspect HealthCare

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dentsply International
• ClinicalTrials.gov Identifier: NCT02979808
• Other Study ID Numbers: NAV-0001
• First Posted: Dec 2, 2016
• Last Update Posted: Dec 12, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Neurogenic Bowel

Study Results

No Results Posted as of Dec 12, 2019