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

Recruiting N/A Interventional Study
Neurogenic Bowel (Disorder) Fecal Constipation Fecal Incontinence Multiple Sclerosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
92 (estimated)
Sponsor
Wellspect HealthCare · Industry
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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.

Trial Locations
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Eligibility 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 …
Contacts

Wellspect HealthCare

+46 31 376 40 00

mace@wellspect.com

CONTACT