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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

Comparing Transanal Irrigation With Navina Smart vs. Standard Bowel Care in Patients With Multiple Sclerosis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

For inclusion in the study, subjects must fulfil all of the following criteria: 1. Provision of informed consent. 2. Female or male aged 18 years or above. 3. Established diagnosis of MS according to McDonald criteria. 4. Patients with bowel symptoms post-dating and related to a diagnosis of MS. 5. Patients suffering from NBD symptoms defined by Wexner feacal incontinence score ≥10 and/or Cleveland Clinic constipation score ≥10 confirmed at Baseline. 6. Only TAI treatment naïve patient (not having previously used any particular TAI system). 7. Judged eligible for TAI as per standardized treatment pathway. 8. Able to read, write and understand information given to them regarding the study.

Exclusion Criteria:

Any of the following is regarded as a criterion for exclusion from the study: 1. 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. 2. Untreated rectal impaction. 3. Other significant neurological diseases (defined as all neurological diseases except for minor functional neurological syndromes or non-MS related neuro complications). 4. Opioid consumption ≤24 hours prior enrolment. 5. Previous colorectal surgery (including haemorrhoidectomy and fistulotomy), sphincter injury, perianal sepsis, rectal prolapse. 6. Performed endoscopic polypectomy within 4 weeks prior enrolment. 7. Ongoing, confirmed pregnancy or lactation. 8. Any neuromodulation that can affect the pelvic organ function. 9. 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).* 10. Current treatment with anticoagulants (exception acetylsalicylic acid or clopidogrel). 11. Current treatment with long-term systemic steroid medication (exception inhalation agents and/or local topical treatment). 12. Current treatment of prokinetics. 13. Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare and site personnel). 14. Previous enrolment in the present study. 15. Simultaneous participation in another clinical study that may interfere with the present study as judged by the investigator. 16. Expected severe non-compliance to protocol as judged by the investigator. 17. Any other condition, as judged by the investigator, which might make follow-up or investigations inappropriate. 18. Any patient that according to the Declaration of Helsinki is unsuitable for enrolment. 19. 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04707976
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Wellspect HealthCare
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Brigitte Schürch, Prof.Bonaventura Casanova, Dr.
Principal Investigator Affiliation Département des neurosciences cliniques Centre Hospitalier Universitaire Vaudois (CHUV); LausanneUnidad de Esclerosis Multiple - Servicio de Neurologica La Fé University Hospital; Valencia
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Denmark, France, Spain, Switzerland, United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Neurogenic Bowel (Disorder), Fecal Constipation, Fecal Incontinence, Multiple Sclerosis
Arms & Interventions

Arms

Experimental: Navina Smart

An electronic medical device to perform transanal irrigation. Treatment period 8 weeks.

Active Comparator: Standard Bowel Care

Supportive bowel care without using irrigation.

Interventions

Device: - Navina Smart

CE-marked NavinaTM Smart including Navina Smart App.

Other: - Standard Bowel Care

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Aarhus University Hospital, Aarhus, Denmark

Status

Recruiting

Address

Aarhus University Hospital

Aarhus, ,

Site Contact

Peter Christensen, Professor

[email protected]

4520375471

Paris, France

Status

Recruiting

Address

Hospital Tenon Service de Neuro-urologie et d'Explorations Périnéales

Paris, , 75020

Site Contact

Gérard Amarenco, Professor

[email protected]

33156017500

La Fé University Hospital, Valencia, Spain

Status

Recruiting

Address

La Fé University Hospital

Valencia, , 46026

Site Contact

Casanova Bonaventura

[email protected]

+34 961 24 40 00

Lausanne, Switzerland

Status

Recruiting

Address

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, , 1011

Site Contact

Brigitte Schürch, Prof.

[email protected]

+41 21 314 11 11

University College London Hospital, London, United Kingdom

Status

Recruiting

Address

University College London Hospital

London, ,

Site Contact

Anton Emmanuel, Professor

[email protected]

442034479130

Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

Read more

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

Visit NARCOMS

Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

Powered By

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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