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

Neurogenic Bowel Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02979808
• Other study ID #: NAV-0001
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: December 2019

Study information

• Verified date: December 2019
• Source: Dentsply International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neurogenic Bowel

Intervention

Device:
• Navina Smart
Subjects treatment-naïve to transanal irrigation (TAI). Frequency of TAI will be tailored to each subject.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
France	Hôpital St Jacques	Nantes	Rennes
Germany	Zentralklinik Bad Berka Gmbh	Bad Berka
Germany	BG-Klinikum Hamburg	Hamburg
Italy	Azienda Ospedaliera- Universitaria Careggi	Firenze	Florence
Italy	Montecatone Rehabilitation Institute, Università di Bologna	Imola	Bologna
Norway	Sunnaas Sykehus HF	Nesoddtangen
Spain	Unidad de Lesionados Medulares Hospital Traumatología	Barcelona
Spain	Complejo Hospitalario Universitario A Coruña	Coruna
Sweden	Neurologiska kliniken, Avd R18 Karolinska Universitetssjukhuset, Solna	Stockholm
United Kingdom	Gastrointestinal Physiology Unit, University College London Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Dentsply International	Wellspect HealthCare

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Italy,  Norway,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of QoL status	To investigate the change of QoL status in the selected patient population (absolute values)	Baseline, 3-months, 12-months
Secondary	NBD symptoms	To investigate NBD symptoms after 6, 9 and 12 months use of Navina Smart system	6-months, 9-months, 12-months
Secondary	Product use compliance.	Study product use compliance (is TAI still performed using the study device).	3-months, 6-months, 9-months, and 12-months
Secondary	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
Secondary	Frequency of urinary tract infection (UTI).	Investigate frequency of UTI using patient reported outcome (PRO) variables.	3-months and 12-months
Secondary	Health economic analysis utilizing QoL data.	To perform health economic analyses using QoL data (EQ-5D).	Baseline, 3-months, and 12-months.
Secondary	Health economic analysis utilizing patient reported outcome (PRO) variables.	To perform health economic analyses using PRO variables.	Baseline, 3-months, and 12-months.
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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