Neurogenic Bowel (Disorder)NCT04707976
Comparing Transanal Irrigation With Navina Smart vs. Standard Bowel Care in Patients With Multiple Sclerosis
A study testing Navina Smart and Standard Bowel Care in people with Neurogenic Bowel (Disorder) and Fecal Constipation, run by Wellspect HealthCare at 9 sites in 6 countries.
Trial summary
A randomized, superiority, controlled, interventional, prospective, multicentre, post-market study of TAI with Navina™ Smart versus Standard Bowel Care performed in a population of 92 subjects suffering from Multiple Sclerosis and confirmed Neurogenic Bowel Dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurogenic Bowel (Disorder), Fecal Constipation, Fecal Incontinence
- What is being tested?
- Navina Smart and Standard Bowel Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 9 sitesin 6 countries
- Study dates
- 1 Dec 2020to Feb 2025
- 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
- For inclusion in the study, subjects must fulfil all of the following criteria:
- Provision of informed consent.
- Female or male aged 18 years or above.
- Established diagnosis of MS according to McDonald criteria.
- Patients with bowel symptoms post-dating and related to a diagnosis of MS.
- Patients suffering from NBD symptoms defined by Wexner feacal incontinence score ≥10 and/or Cleveland Clinic constipation score ≥10 confirmed at Baseline.
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- Only TAI treatment naïve patient (not having previously used any particular TAI system).
- Judged eligible for TAI as per standardized treatment pathway.
- Able to read, write and understand information given to them regarding the study.
Who cannot join
- Any of the following is regarded as a criterion for exclusion from the study:
- Any confirmed or suspected diagnosis of anal or colorectal 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.
- Other significant neurological diseases (defined as all neurological diseases except for minor functional neurological syndromes or non-MS related neuro complications).
- Opioid consumption ≤24 hours prior enrolment.
- Previous colorectal surgery (including haemorrhoidectomy and fistulotomy), sphincter injury, perianal sepsis, rectal prolapse.
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- Performed endoscopic polypectomy within 4 weeks prior enrolment.
- Ongoing, confirmed pregnancy or lactation.
- Any neuromodulation that can affect the pelvic organ function.
- Ongoing, symptomatic Urinary Tract Infection (UTI) at enrolment (defined as a positive urine culture of ≥10^3 CFU/ml of ≥1 bacterial species and presence of symptoms or signs compatible with UTI with no other identified source of infection).*
- Current treatment with anticoagulants (exception acetylsalicylic acid or clopidogrel).
- Current treatment with long-term systemic steroid medication (exception inhalation agents and/or local topical treatment).
- Current treatment of prokinetics.
- Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare and site personnel).
- Previous enrolment in the present study.
- Simultaneous participation in another clinical study that may interfere with the present study as judged by the investigator.
- Expected severe non-compliance to protocol as judged by the investigator.
- Any other condition, as judged by the investigator, which might make follow-up or investigations inappropriate.
- Any patient that according to the Declaration of Helsinki is unsuitable for enrolment.
- Agranulocytosis (<0.5 10^9 / L) [Only applicable for Switzerland].
- If symptoms and signs compatible with UTI is present but no urine culture test has been performed yet, a test should be performed, and the result received prior evaluating if the subject is eligible for study participation. After successful and completed treatment of a UTI, the subject may be rescheduled for Visit 1 in order to re-evaluate study participation.
Trial locations and contacts
9 sites in 6 countries.
9 sites in 6 countries
Italy4 sites, 4 recruiting
- Recruiting
Azienda Ospedaliero Universitaria Consorziale Policlinico con sede in Bari
Bari, 70124
Giuseppina Dr Frasca, Dr
Giuseppina Dr Frasca, Dr
- Recruiting
Azienda Ospedaliero-Universitaria of Ferrara
Ferrara, Cona, 44124
Simona Ascanelli, Dr
Simona Ascanelli, Dr
- Recruiting
AOU Careggi
Florence, Tuscany, 510 34
Giulio Del Popolo, Dr
Giulio Del Popolo
- Recruiting
AISM Liguria Rehabilitation Centre
Genoa, Liguria, 16149
Dr Giampaolo Brichetto, Dr
Giampaolo Brichetto
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus
Peter Christensen, Professor, 4520375471
Peter Christensen, Professor
France1 site, 1 recruiting
- Recruiting
Hospital Tenon Service de Neuro-urologie et d'Explorations Périnéales
Paris, 75020
Gérard Amarenco, Professor, 33156017500
Gérard Amarenco, Professor
Spain1 site, 1 recruiting
- Recruiting
La Fé University Hospital
Valencia, 46026
Casanova Bonaventura, +34 961 24 40 00
Switzerland1 site
- Withdrawn
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, 1011
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospital
London
Anton Emmanuel, Professor, 442034479130
Anton Emmanuel, Professor
About this study
Official title: A Randomized Controlled Trial Comparing the Efficacy of Transanal Irrigation With Navina Smart Versus Standard Bowel Care in Patients With Multiple Sclerosis
A randomized, superiority, controlled, interventional, prospective, multicentre, post-market study of TAI with Navina™ Smart versus Standard Bowel Care performed in a population of 92 subjects suffering from Multiple Sclerosis and confirmed Neurogenic Bowel Dysfunction. The study is expected to last for a total of 8 weeks per subject with two scheduled site visits.
- Being tested
- Navina Smart, Standard Bowel Care
- Medical subject headings
- Neurogenic Bowel, Fecal Incontinence, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navina SmartDevice
CE-marked NavinaTM Smart including Navina Smart App.
Standard Bowel CareOther
Bowel care will be scheduled at least every 2nd day according to a defined study specific standard bowel care protocol. Diet, fluids, abdominal massage, regular physical activity and medications will be used if non-interventional treatment is insufficient.
| Study group | Role | What they receive |
|---|---|---|
| Navina Smart | Experimental | An electronic medical device to perform transanal irrigation. Treatment period 8 weeks. Receives: Device: Navina Smart |
| Standard Bowel Care | Active comparator | Supportive bowel care without using irrigation. Receives: Other: Standard Bowel Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fecal incontinence score.
Relative change in Wexner fecal incontinence score at 8 weeks relative to Baseline in the TAI arm, compared to the SBC arm.
Measured: 8 weeks
Change in fecal constipation score
Relative change in Cleveland Clinic constipation score at 8 weeks relative to Baseline in the TAI arm, compared to the SBC arm.
Measured: 8 weeks.
Secondary outcomes (25)
Efficacy of TAI with Navina Smart vs. SBC
Absolute change in Wexner fecal incontinence score at 4 weeks relative to Baseline in the TAI arm, compared to the SBC arm.
Measured: 4 weeks
Efficacy of TAI with Navina Smart vs. SBC
Absolute change in Wexner fecal incontinence score at 8 weeks relative to Baseline in the TAI arm, compared to the SBC arm.
Measured: 8 weeks
Efficacy of TAI with Navina Smart vs. SBC
Absolute change in Cleveland Clinic constipation score at 4 relative to Baseline in the TAI arm, compared to the SBC arm.
Measured: 4 weeks
Efficacy of TAI with Navina Smart vs. SBC
Absolute change in Cleveland Clinic constipation score at 4 relative to Baseline in the TAI arm, compared to the SBC arm.
Measured: 8 weeks
Efficacy of TAI with Navina Smart vs. SBC
Relative change in Wexner fecal incontinence score at 4 weeks relative to Baseline in the TAI arm, compared to the SBC arm.
Measured: 4 weeks
Efficacy of TAI with Navina Smart vs. SBC
Relative change in Wexner fecal incontinence score at 4 weeks relative to Baseline in the TAI arm, compared to the SBC arm.
Measured: 8 weeks
Efficacy of TAI with Navina Smart vs. SBC
Relative change in Cleveland Clinic constipation score at 4 weeks relative to Baseline in the TAI arm, compared to the SBC arm
Measured: 4 weeks
Efficacy of TAI with Navina Smart vs. SBC
Relative change in Cleveland Clinic constipation score at 4 weeks relative to Baseline in the TAI arm, compared to the SBC arm
Measured: 8 weeks
Change in perception of impact of bowel symptoms on QoL
Relative change of impact on bowel-related QoL between baseline and 8 weeks in the TAI arm, compared to the SBC arm, as measured by a single question.
Measured: 8 weeks
Change in NBD symptoms
Absolute and relative change in NBD score between Baseline and 4 and 8 weeks in the Navina arm, compared to the SBC arm.
Measured: 4 weeks and 8 weeks
Change in bladder specific QoL
Absolute and relative change in SF-Qualiveen questionnaire between Baseline and 8 weeks in the TAI arm, compared to the SBC arm.
Measured: 8 weeks
Study therapy adherence
Number of subjects using Navina Smart or SBC at 4 weeks and 8 weeks treatment, as measured by a single question.
Measured: 4 weeks and 8 weeks
Frequency of UTI
Number of UTIs requiring antibiotic treatment 8 weeks prior study start (Baseline) and at 8 weeks after treatment (Visit 2), as reported by subject.
Measured: 8 weeks
Navina Smart: Correlation APP/irrigation parameters
Volume correlation with Anorectal Physiology Parameters (APPs) up to 3 weeks from baseline in subjects who perform the anorectal physiology test, treated with Navina Smart, and using the Navina Smart App.
Measured: Up to 3 weeks
Navina Smart: Correlation APP/irrigation parameters
Volume correlation with Anorectal Physiology Parameters (APPs) after 4 weeks in subjects who perform the anorectal physiology test, treated with Navina Smart, and using the Navina Smart App
Measured: 4 weeks
Navina Smart: Correlation APP/irrigation parameters
Volume correlation with Anorectal Physiology Parameters (APPs) after 8 weeks in subjects who perform the anorectal physiology test, treated with Navina Smart, and using the Navina Smart App
Measured: 8 weeks.
Navina Smart: Correlation APP/irrigation parameters
Frequency of irrigations correlation with Anorectal Physiology Parameters (APPs) up to 3 weeks from baseline in subjects who perform the anorectal physiology test, treated with Navina Smart, and using the Navina Smart App
Measured: Up to 3 weeks
Navina Smart: Correlation APP/irrigation parameters
Frequency of irrigations correlation with Anorectal Physiology Parameters (APPs) after 4 weeks in subjects who perform the anorectal physiology test, treated with Navina Smart, and using the Navina Smart App.
Measured: 4 weeks
Navina Smart: Correlation APP/irrigation parameters
Frequency of irrigations correlation with Anorectal Physiology Parameters (APPs) after 8 weeks in subjects who perform the anorectal physiology test, treated with Navina Smart, and using the Navina Smart App.
Measured: 8 weeks.
Navina Smart: Correlation APP/irrigation parameters
Balloon inflation correlation with Anorectal Physiology Parameters (APPs) up to 3 weeks from baseline in subjects who perform the anorectal physiology test, treated with Navina Smart, and using the Navina Smart App
Measured: Up to 3 weeks
Navina Smart: Correlation APP/irrigation parameters
Balloon inflation correlation with Anorectal Physiology Parameters (APPs) after 4 weeks in subjects who perform the anorectal physiology test, treated with Navina Smart, and using the Navina Smart App
Measured: 4 weeks
Navina Smart: Correlation APP/irrigation parameters
Balloon inflation correlation with Anorectal Physiology Parameters (APPs) after 8 weeks in subjects who perform the anorectal physiology test, treated with Navina Smart, and using the Navina Smart App.
Measured: 8 weeks.
Navina Smart: Correlation anorectal APP/irrigation parameters between responders/non-responders
Correlation between Anorectal Physiology Parameters (APPs), irrigations parameters (volume/frequency of irrigation and balloon inflation) and outcome of TAI treatment between responders versus non-responders in subjects who perform the anorectal physiology test, treated with Navina Smart, and using the Navina Smart App from baseline to 3 weeks. A responder is defined as an improvement equal to the 25th percentile of the change in Cleveland Clinic Constipation score when using TAI with Navina Smart.
Measured: Up to 3 weeks
Navina Smart: Correlation anorectal APP/irrigation parameters between responders/non-responders
Correlation between Anorectal Physiology Parameters (APPs), irrigations parameters (volume/frequency of irrigation and balloon inflation) and outcome of TAI treatment between responders versus non-responders in subjects who perform the anorectal physiology test, treated with Navina Smart, and using the Navina Smart App for 4 weeks. A responder is defined as an improvement equal to the 25th percentile of the change in Cleveland Clinic Constipation score when using TAI with Navina Smart.
Measured: 4 weeks
Navina Smart: Correlation anorectal APP/irrigation parameters between responders/non-responders
Correlation between Anorectal Physiology Parameters (APPs), irrigations parameters(volume/frequency of irrigation and balloon inflation) and outcome of TAI treatment between responders versus non-responders in subjects who perform the anorectal physiology test, treated with Navina Smart, and using the Navina Smart App for 8 weeks. A responder is defined as an improvement equal to the 25th percentile of the change in Cleveland Clinic Constipation score when using TAI with Navina Smart.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start1 Dec 2020
- Primary completionDec 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic Bowel (Disorder)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wellspect HealthCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brigitte Schürch, Prof., Principal investigator, Département des neurosciences cliniques Centre Hospitalier Universitaire Vaudois (CHUV); LausanneBonaventura Casanova, Dr., Principal investigator, Unidad de Esclerosis Multiple - Servicio de Neurologica La Fé University Hospital; Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707976
- Sponsor's protocol ID
- NAV-0006
- Status last verified
- Jul 2024
- First submitted
- 22 Oct 2020
- Last updated
- 11 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing the Efficacy of Transanal Irrigation With Navina Smart Versus Standard Bowel Care in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04707976
- Acronym / sponsor ID
- NAV-0006
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Wellspect HealthCareIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 13 Jan 2021 (actual)
- 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.
A randomized, superiority, controlled, interventional, prospective, multicentre, post-market study of TAI with Navina™ Smart versus Standard Bowel Care performed in a population of 92 subjects suffering from Multiple Sclerosis and confirmed Neurogenic Bowel Dysfunction. The study is expected to last for a total of 8 weeks per subject with two scheduled site visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Navina Smart | Experimental | Device: Navina SmartAn electronic medical device to perform transanal irrigation. Treatment period 8 weeks. |
| Standard Bowel Care | Active comparator | Other: Standard Bowel CareSupportive bowel care without using irrigation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provision of informed consent.
- Female or male aged 18 years or above.
- Established diagnosis of MS according to McDonald criteria.
- Patients with bowel symptoms post-dating and related to a diagnosis of MS.
- Patients suffering from NBD symptoms defined by Wexner feacal incontinence score ≥10 and/or Cleveland Clinic constipation score ≥10 confirmed at Baseline.
Key exclusion criteria (21 listed)
- Any confirmed or suspected diagnosis of anal or colorectal 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.
- Other significant neurological diseases (defined as all neurological diseases except for minor functional neurological syndromes or non-MS related neuro complications).
- Opioid consumption ≤24 hours prior enrolment.
- Previous colorectal surgery (including haemorrhoidectomy and fistulotomy), sphincter injury, perianal sepsis, rectal prolapse.
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 SmartCE-marked NavinaTM Smart including Navina Smart App. | Device | Navina Smart |
| Standard Bowel CareBowel care will be scheduled at least every 2nd day according to a defined study specific standard bowel care protocol. Diet, fluids, abdominal massage, regular physical activity and medications will be used if non-interventional treatment is insufficient. | Other | Standard Bowel Care |
Primary outcome
Change in fecal incontinence score.
Time frame: 8 weeks
Relative change in Wexner fecal incontinence score at 8 weeks relative to Baseline in the TAI arm, compared to the SBC arm.
Change in fecal constipation score
Time frame: 8 weeks.
Relative change in Cleveland Clinic constipation score at 8 weeks relative to Baseline in the TAI arm, compared to the SBC arm.
25 secondary outcomes
Efficacy of TAI with Navina Smart vs. SBC
Time frame: 4 weeks
Efficacy of TAI with Navina Smart vs. SBC
Time frame: 8 weeks
Efficacy of TAI with Navina Smart vs. SBC
Time frame: 4 weeks
Efficacy of TAI with Navina Smart vs. SBC
Time frame: 8 weeks
Efficacy of TAI with Navina Smart vs. SBC
Time frame: 4 weeks
Efficacy of TAI with Navina Smart vs. SBC
Time frame: 8 weeks
Efficacy of TAI with Navina Smart vs. SBC
Time frame: 4 weeks
Efficacy of TAI with Navina Smart vs. SBC
Time frame: 8 weeks
Change in perception of impact of bowel symptoms on QoL
Time frame: 8 weeks
Change in NBD symptoms
Time frame: 4 weeks and 8 weeks
Change in bladder specific QoL
Time frame: 8 weeks
Study therapy adherence
Time frame: 4 weeks and 8 weeks
Frequency of UTI
Time frame: 8 weeks
Navina Smart: Correlation APP/irrigation parameters
Time frame: Up to 3 weeks
Navina Smart: Correlation APP/irrigation parameters
Time frame: 4 weeks
Navina Smart: Correlation APP/irrigation parameters
Time frame: 8 weeks.
Navina Smart: Correlation APP/irrigation parameters
Time frame: Up to 3 weeks
Navina Smart: Correlation APP/irrigation parameters
Time frame: 4 weeks
Navina Smart: Correlation APP/irrigation parameters
Time frame: 8 weeks.
Navina Smart: Correlation APP/irrigation parameters
Time frame: Up to 3 weeks
Navina Smart: Correlation APP/irrigation parameters
Time frame: 4 weeks
Navina Smart: Correlation APP/irrigation parameters
Time frame: 8 weeks.
Navina Smart: Correlation anorectal APP/irrigation parameters between responders/non-responders
Time frame: Up to 3 weeks
Navina Smart: Correlation anorectal APP/irrigation parameters between responders/non-responders
Time frame: 4 weeks
Navina Smart: Correlation anorectal APP/irrigation parameters between responders/non-responders
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
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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.
Brigitte Schürch, Prof. principal investigator
Département des neurosciences cliniques Centre Hospitalier Universitaire Vaudois (CHUV); Lausanne
Bonaventura Casanova, Dr. principal investigator
Unidad de Esclerosis Multiple - Servicio de Neurologica La Fé University Hospital; Valencia
9 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navina Smart and Standard Bowel Care in people with Neurogenic Bowel (Disorder) and Fecal Constipation, run by Wellspect HealthCare at 9 sites in 6 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 9 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy, Denmark, France, Spain, Switzerland and 1 more country. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wellspect HealthCare (+46 31 376 40 00, mace@wellspect.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fecal incontinence score. (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2024.