Neurogenic BowelNCT02979808
An Open, Qualitative, Prospective, Multicenter Trial of a Novel Transanal Irrigation System in Spinal Cord Injured Patients.
A study testing Navina Smart in people with Neurogenic Bowel, run by Dentsply International at 11 sites in 8 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurogenic Bowel
- What is being tested?
- Navina Smart
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 11 sitesin 8 countries
- Study dates
- Oct 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
11 sites in 8 countries.
11 sites in 8 countries
Germany2 sites
Zentralklinik Bad Berka Gmbh
Bad Berka, 99437
BG-Klinikum Hamburg
Hamburg, 21033
Italy2 sites
Azienda Ospedaliera- Universitaria Careggi
Florence, Florence, 50134
Montecatone Rehabilitation Institute, Università di Bologna
Imola, Bologna, 40026
Spain2 sites
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006
Unidad de Lesionados Medulares Hospital Traumatología
Barcelona, 08035
Sweden1 site
Neurologiska kliniken, Avd R18 Karolinska Universitetssjukhuset, Solna
Stockholm, 171 76
United Kingdom1 site
Gastrointestinal Physiology Unit, University College London Hospital
London, NW1 2BU
About this study
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.
Read the 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
- Conditions
- Neurogenic Bowel
- Being tested
- Navina Smart
- Medical subject headings
- Neurogenic Bowel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navina SmartDevice
Subjects treatment-naïve to transanal irrigation (TAI). Frequency of TAI will be tailored to each subject.
| Study group | Role | What they receive |
|---|---|---|
| Navina Smart | Experimental | Navina Smart will be used during 12 months for transanal irrigation (TAI). Receives: Device: Navina Smart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neurogenic bowel disfunction symptoms.
- 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.
Measured: 3 months
Secondary outcomes (11)
Change of QoL status
To investigate the change of QoL status in the selected patient population (absolute values)
Measured: Baseline, 3-months, 12-months
NBD symptoms
To investigate NBD symptoms after 6, 9 and 12 months use of Navina Smart system
Measured: 6-months, 9-months, 12-months
Product use compliance.
Study product use compliance (is TAI still performed using the study device).
Measured: 3-months, 6-months, 9-months, and 12-months
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.
Measured: 3-months and 12-months
Frequency of urinary tract infection (UTI).
Investigate frequency of UTI using patient reported outcome (PRO) variables.
Measured: 3-months and 12-months
Health economic analysis utilizing QoL data.
To perform health economic analyses using QoL data (EQ-5D).
Measured: Baseline, 3-months, and 12-months.
Health economic analysis utilizing patient reported outcome (PRO) variables.
To perform health economic analyses using PRO variables.
Measured: Baseline, 3-months, and 12-months.
Thematic analysis of interview data.
To understand individual experience of initiating and using TAI for neurogenic bowel dysfunction.
Measured: Baseline, 3-months, and 12-months (or at end of treatment period).
Thematic analysis of interview data.
To explore individual perceptions of using TAI compared with other conservative treatments for neurogenic bowel dysfunction.
Measured: Baseline, 3-months, and 12-months (or at end of treatment period).
Thematic analysis of interview data.
To explore what influences individuals to continue with or stop using TAI for neurogenic bowel dysfunction.
Measured: Baseline, 3-months, and 12-months (or at end of treatment period).
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.
Measured: 3-months, 6-months, 9-months, 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurogenic BowelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dentsply International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wellspect HealthCare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979808
- Sponsor's protocol ID
- NAV-0001
- Status last verified
- Dec 2019
- First submitted
- 7 Nov 2016
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33513187
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Qualitative, Prospective, Multicenter Trial of a Novel Transanal Irrigation System in Spinal Cord Injured Patients.
- ClinicalTrials.gov ID
- NCT02979808
- Acronym / sponsor ID
- NAV-0001
- Conditions
- Neurogenic Bowel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Dentsply InternationalIndustry (pharma, biotech, devices)
- Collaborators
- Wellspect HealthCare
- Study start
- Oct 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Navina Smart | Experimental | Device: Navina SmartNavina Smart will be used during 12 months for transanal irrigation (TAI). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Provision of informed consent.
- Male or female aged 18 years or older.
- Patient with previously confirmed chronic spinal cord injury, either:
- At least 3 months post spinal cord injury at time of consent.
- NBD score ≥10, confirmed at Baseline .
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navina SmartSubjects treatment-naïve to transanal irrigation (TAI). Frequency of TAI will be tailored to each subject. | Device | Navina Smart |
Primary outcome
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.
11 secondary outcomes
Change of QoL status
Time frame: Baseline, 3-months, 12-months
NBD symptoms
Time frame: 6-months, 9-months, 12-months
Product use compliance.
Time frame: 3-months, 6-months, 9-months, and 12-months
Patient satisfaction assessed through patient reported outcome (PRO) variables.
Time frame: 3-months and 12-months
Frequency of urinary tract infection (UTI).
Time frame: 3-months and 12-months
Health economic analysis utilizing QoL data.
Time frame: Baseline, 3-months, and 12-months.
Health economic analysis utilizing patient reported outcome (PRO) variables.
Time frame: Baseline, 3-months, and 12-months.
Thematic analysis of interview data.
Time frame: Baseline, 3-months, and 12-months (or at end of treatment period).
Thematic analysis of interview data.
Time frame: Baseline, 3-months, and 12-months (or at end of treatment period).
Thematic analysis of interview data.
Time frame: Baseline, 3-months, and 12-months (or at end of treatment period).
Incidence of adverse events, serious adverse events, and adverse device effects.
Time frame: 3-months, 6-months, 9-months, 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Derived from this study: PubMed 33513187Emmanuel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navina Smart in people with Neurogenic Bowel, run by Dentsply International at 11 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, Italy, Spain, Denmark, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in neurogenic bowel disfunction symptoms. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02979808, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.