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

Primary Purpose

Neurogenic Bowel

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Navina Smart

About this trial

This is an interventional other trial for Neurogenic Bowel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Provision of informed consent.
Male or female aged 18 years or older.
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.
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.

Sites / Locations

Aarhus University Hospital
Hôpital St Jacques
Zentralklinik Bad Berka Gmbh
BG-Klinikum Hamburg
Montecatone Rehabilitation Institute, Università di Bologna
Azienda Ospedaliera- Universitaria Careggi
Sunnaas Sykehus HF
Unidad de Lesionados Medulares Hospital Traumatología
Complejo Hospitalario Universitario A Coruña
Neurologiska kliniken, Avd R18 Karolinska Universitetssjukhuset, Solna
Gastrointestinal Physiology Unit, University College London Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Navina Smart

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change of QoL status

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

NBD symptoms

To investigate NBD symptoms after 6, 9 and 12 months use of Navina Smart system

Product use compliance.

Study product use compliance (is TAI still performed using the study device).

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.

Frequency of urinary tract infection (UTI).

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

Health economic analysis utilizing QoL data.

To perform health economic analyses using QoL data (EQ-5D).

Health economic analysis utilizing patient reported outcome (PRO) variables.

To perform health economic analyses using PRO variables.

Thematic analysis of interview data.

To understand individual experience of initiating and using TAI for neurogenic bowel dysfunction.

Thematic analysis of interview data.

To explore individual perceptions of using TAI compared with other conservative treatments for neurogenic bowel dysfunction.

Thematic analysis of interview data.

To explore what influences individuals to continue with or stop using TAI for neurogenic bowel dysfunction.

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.

Full Information

NCT ID

NCT02979808

First Posted

November 7, 2016

Last Updated

December 11, 2019

Sponsor

Dentsply International

Collaborators

Wellspect HealthCare

1. Study Identification

Unique Protocol Identification Number

NCT02979808

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

October 2016 (undefined)

Primary Completion Date

December 2019 (Actual)

Study Completion Date

December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dentsply International

Collaborators

Wellspect HealthCare

4. Oversight

Data Monitoring Committee

5. 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neurogenic Bowel

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Navina Smart

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Navina Smart

Intervention Description

Subjects treatment-naïve to transanal irrigation (TAI). Frequency of TAI will be tailored to each subject.

Primary Outcome Measure Information:

Title

Change in neurogenic bowel disfunction symptoms.

Description

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Change of QoL status

Description

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

Time Frame

Baseline, 3-months, 12-months

Title

NBD symptoms

Description

To investigate NBD symptoms after 6, 9 and 12 months use of Navina Smart system

Time Frame

6-months, 9-months, 12-months

Title

Product use compliance.

Description

Study product use compliance (is TAI still performed using the study device).

Time Frame

3-months, 6-months, 9-months, and 12-months

Title

Patient satisfaction assessed through patient reported outcome (PRO) variables.

Description

To investigate patient perception and satisfaction of bowel management including TAI therapy and use of the Navina Smart system.

Time Frame

3-months and 12-months

Title

Frequency of urinary tract infection (UTI).

Description

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

Time Frame

3-months and 12-months

Title

Health economic analysis utilizing QoL data.

Description

To perform health economic analyses using QoL data (EQ-5D).

Time Frame

Baseline, 3-months, and 12-months.

Title

Health economic analysis utilizing patient reported outcome (PRO) variables.

Description

To perform health economic analyses using PRO variables.

Time Frame

Baseline, 3-months, and 12-months.

Title

Thematic analysis of interview data.

Description

To understand individual experience of initiating and using TAI for neurogenic bowel dysfunction.

Time Frame

Baseline, 3-months, and 12-months (or at end of treatment period).

Title

Thematic analysis of interview data.

Description

To explore individual perceptions of using TAI compared with other conservative treatments for neurogenic bowel dysfunction.

Time Frame

Baseline, 3-months, and 12-months (or at end of treatment period).

Title

Thematic analysis of interview data.

Description

To explore what influences individuals to continue with or stop using TAI for neurogenic bowel dysfunction.

Time Frame

Baseline, 3-months, and 12-months (or at end of treatment period).

Title

Incidence of adverse events, serious adverse events, and adverse device effects.

Description

To evaluate short- and long-term safety of the product and therapy by assessing adverse events, serious adverse events, adverse device effects.

Time Frame

3-months, 6-months, 9-months, 12-months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Aarhus University Hospital

City

Aarhus

ZIP/Postal Code

8000

Country

Denmark

Facility Name

Hôpital St Jacques

City

Nantes

State/Province

Rennes

ZIP/Postal Code

44093

Country

France

Facility Name

Zentralklinik Bad Berka Gmbh

City

Bad Berka

ZIP/Postal Code

99437

Country

Germany

Facility Name

BG-Klinikum Hamburg

City

Hamburg

ZIP/Postal Code

21033

Country

Germany

Facility Name

Montecatone Rehabilitation Institute, Università di Bologna

City

Imola

State/Province

Bologna

ZIP/Postal Code

40026

Country

Italy

Facility Name

Azienda Ospedaliera- Universitaria Careggi

City

Firenze

State/Province

Florence

ZIP/Postal Code

50134

Country

Italy

Facility Name

Sunnaas Sykehus HF

City

Nesoddtangen

ZIP/Postal Code

1450

Country

Norway

Facility Name

Unidad de Lesionados Medulares Hospital Traumatología

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Complejo Hospitalario Universitario A Coruña

City

Coruna

ZIP/Postal Code

15006

Country

Spain

Facility Name

Neurologiska kliniken, Avd R18 Karolinska Universitetssjukhuset, Solna

City

Stockholm

ZIP/Postal Code

171 76

Country

Sweden

Facility Name

Gastrointestinal Physiology Unit, University College London Hospital

City

London

ZIP/Postal Code

NW1 2BU

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33513187

Citation

Emmanuel A, Kurze I, Krogh K, Ferreiro Velasco ME, Christensen P, Del Popolo G, Bazzocchi G, Hultling C, Perrouin Verbe B, Bothig R, Glott T, Gonzalez Viejo MA. An open prospective study on the efficacy of Navina Smart, an electronic system for transanal irrigation, in neurogenic bowel dysfunction. PLoS One. 2021 Jan 29;16(1):e0245453. doi: 10.1371/journal.pone.0245453. eCollection 2021.

Results Reference

derived

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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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