NCT02979808

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
8 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 7, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 2, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 12, 2019

Status Verified

December 1, 2019

Enrollment Period

3.2 years

First QC Date

November 7, 2016

Last Update Submit

December 11, 2019

Conditions

Neurogenic Bowel

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Change of QoL status

    Baseline, 3-months, 12-months

  • NBD symptoms

    6-months, 9-months, 12-months

  • Product use compliance.

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

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

    3-months and 12-months

  • Frequency of urinary tract infection (UTI).

    3-months and 12-months

  • +6 more secondary outcomes

Study Arms (1)

Navina Smart

EXPERIMENTAL

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

Device: Navina Smart

Interventions

Navina SmartDEVICE

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

Navina Smart

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Hôpital St Jacques

Nantes, Rennes, 44093, France

Location

Zentralklinik Bad Berka Gmbh

Bad Berka, 99437, Germany

Location

BG-Klinikum Hamburg

Hamburg, 21033, Germany

Location

Montecatone Rehabilitation Institute, Università di Bologna

Imola, Bologna, 40026, Italy

Location

Azienda Ospedaliera- Universitaria Careggi

Florence, Florence, 50134, Italy

Location

Sunnaas Sykehus HF

Nesoddtangen, 1450, Norway

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, 15006, Spain

Location

Unidad de Lesionados Medulares Hospital Traumatología

Barcelona, 08035, Spain

Location

Neurologiska kliniken, Avd R18 Karolinska Universitetssjukhuset, Solna

Stockholm, 171 76, Sweden

Location

Gastrointestinal Physiology Unit, University College London Hospital

London, NW1 2BU, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 33513187DERIVED

MeSH Terms

Conditions

Neurogenic Bowel

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2016

First Posted

December 2, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

December 12, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)IT(2)NO(1)FR(1)DE(2)SE(1)GB(1)ES(2)