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

Wellspect HealthCare9 sites in 6 countries92 target enrollmentDecember 1, 2020

ConditionsNeurogenic Bowel (Disorder)Fecal Constipation Fecal Incontinence Multiple Sclerosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Neurogenic Bowel (Disorder)
Sponsor: Wellspect HealthCare
Enrollment: 92
Locations: 9
Primary Endpoint: Change in fecal incontinence score.
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 1, 2020

End Date

February 2025

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Wellspect HealthCare

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•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.

Exclusion Criteria

•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.
•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).\*

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Change in perception of impact of bowel symptoms on QoL(8 weeks)
Change in bladder specific QoL(8 weeks)
Navina Smart: Correlation APP/irrigation parameters(8 weeks.)
Change in NBD symptoms(4 weeks and 8 weeks)
Study therapy adherence(4 weeks and 8 weeks)
Frequency of UTI(8 weeks)
Efficacy of TAI with Navina Smart vs. SBC(8 weeks)
Navina Smart: Correlation anorectal APP/irrigation parameters between responders/non-responders(8 weeks)