NCT04707976

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

A Randomized Controlled Trial Comparing the Efficacy of Transanal Irrigation With Navina Smart Versus Standard Bowel Care in Patients With Multiple Sclerosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Wellspect HealthCare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. The study is expected to last for a total of 8 weeks per subject with two scheduled site visits.

Conditions

• Neurogenic Bowel (Disorder)
• Fecal Constipation
• Fecal Incontinence
• Multiple Sclerosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-12-01
• Primary completion: 2024-12-01
• Completion: 2025-02-01
• First posted: 2021-01-13
• Last updated: 2024-07-11

Locations

9 sites across 6 countries: Denmark, France, Italy, Spain, Switzerland, United Kingdom