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UNKNOWNNA

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

Sponsor: Wellspect HealthCare

NCT ID: NCT04707976

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Navina Smart (device), Standard Bowel Care (other)
How long the study runs
Study runs about 50 months (dates as stated)
About the drug or intervention
Navina Smart — device: CE-marked NavinaTM Smart including Navina Smart App. · Standard Bowel Care — other: Bowel care will be scheduled at least every 2nd day according to a defined study specific standard bowel care protocol.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
92
Started
2020-12-01
Last checked
2024-07

Plain English Summary

What is this study?

  • • Testing a new treatment for neurogenic bowel (disorder)
  • • NA - 92 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with neurogenic bowel (disorder)

Where?

  • • London - University College London Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Neurogenic Bowel (Disorder)Fecal ConstipationFecal IncontinenceMultiple Sclerosis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

as a positive

What the study is looking for

  • ✓For inclusion in the study, subjects must fulfil all of the following criteria:
  • ✓Provision of agreement to take part.
  • ✓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.

Who cannot take part

  • ✗Any of the following is regarded as a criterion for exclusion from the study:
  • ✗Untreated rectal impaction.
  • ✗Other significant neurological diseases (defined as all neurological diseases except for minor functional...
  • ✗Opioid consumption ≤24 hours prior enrolment.
  • ✗Previous colorectal surgery (including haemorrhoidectomy and fistulotomy), sphincter injury, perianal sepsis, rectal...
See the full 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.

Where Is This Study? (1 UK site)

University College London Hospital

London, United Kingdom

Recruiting
Site contact (verified)
Anton Emmanuel, ProfessorPrincipal Investigator
Anton Emmanuel, Professor442034479130

How to Get in Touch

Wellspect HealthCare

Sponsor contact

CONTACT

+46 31 376 40 00 mace@wellspect.com
Data sourced from ClinicalTrials.gov · Last verified: 2024-07