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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis; Fecal Incontinence; Neurogenic Bowel (Disorder); Fecal Constipation
• Intervention / Treatment: Device: Navina Smart; Other: Standard Bowel Care

• Study Type: Interventional
• Enrollment (Anticipated): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark
    • Recruiting
    • Aarhus University Hospital
• France
  • Paris, France, 75020
    • Recruiting
    • Hospital Tenon Service de Neuro-urologie et d'Explorations Périnéales
• Spain
  • Valencia, Spain, 46026
    • Recruiting
    • La Fe University Hospital
• Switzerland
  • Lausanne, Switzerland, 1011
    • Recruiting
    • Centre Hospitalier Universitaire Vaudois (Chuv)
• United Kingdom
  • London, United Kingdom
    • Recruiting
    • University College London Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Navina Smart; An electronic medical device to perform transanal irrigation. Treatment period 8 weeks.	Device: Navina Smart; CE-marked NavinaTM Smart including Navina Smart App.
Active Comparator: Standard Bowel Care; Supportive bowel care without using irrigation.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fecal incontinence score.	Relative change in Wexner fecal incontinence score at 8 weeks relative to Baseline in the TAI arm, compared to the SBC arm.	8 weeks
Change in fecal constipation score	Relative change in Cleveland Clinic constipation score at 8 weeks relative to Baseline in the TAI arm, compared to the SBC arm.	8 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of TAI with Navina Smart vs. SBC	Absolute change in Wexner fecal incontinence score at 4 weeks relative to Baseline in the TAI arm, compared to the SBC arm.	4 weeks
Efficacy of TAI with Navina Smart vs. SBC	Absolute change in Wexner fecal incontinence score at 8 weeks relative to Baseline in the TAI arm, compared to the SBC arm.	8 weeks
Efficacy of TAI with Navina Smart vs. SBC	Absolute change in Cleveland Clinic constipation score at 4 relative to Baseline in the TAI arm, compared to the SBC arm.	4 weeks
Efficacy of TAI with Navina Smart vs. SBC	Absolute change in Cleveland Clinic constipation score at 4 relative to Baseline in the TAI arm, compared to the SBC arm.	8 weeks
Efficacy of TAI with Navina Smart vs. SBC	Relative change in Wexner fecal incontinence score at 4 weeks relative to Baseline in the TAI arm, compared to the SBC arm.	4 weeks
Efficacy of TAI with Navina Smart vs. SBC	Relative change in Wexner fecal incontinence score at 4 weeks relative to Baseline in the TAI arm, compared to the SBC arm.	8 weeks
Efficacy of TAI with Navina Smart vs. SBC	Relative change in Cleveland Clinic constipation score at 4 weeks relative to Baseline in the TAI arm, compared to the SBC arm	4 weeks
Efficacy of TAI with Navina Smart vs. SBC	Relative change in Cleveland Clinic constipation score at 4 weeks relative to Baseline in the TAI arm, compared to the SBC arm	8 weeks
Change in perception of impact of bowel symptoms on QoL	Relative change of impact on bowel-related QoL between baseline and 8 weeks in the TAI arm, compared to the SBC arm, as measured by a single question.	8 weeks
Change in NBD symptoms	Absolute and relative change in NBD score between Baseline and 4 and 8 weeks in the Navina arm, compared to the SBC arm.	4 weeks and 8 weeks
Change in bladder specific QoL	Absolute and relative change in SF-Qualiveen questionnaire between Baseline and 8 weeks in the TAI arm, compared to the SBC arm.	8 weeks
Study therapy adherence	Number of subjects using Navina Smart or SBC at 4 weeks and 8 weeks treatment, as measured by a single question.	4 weeks and 8 weeks
Frequency of UTI	Number of UTIs requiring antibiotic treatment 8 weeks prior study start (Baseline) and at 8 weeks after treatment (Visit 2), as reported by subject.	8 weeks
Navina Smart: Correlation APP/irrigation parameters	Volume correlation with Anorectal Physiology Parameters (APPs) up to 3 weeks from baseline in subjects who perform the anorectal physiology test, treated with Navina Smart, and using the Navina Smart App.	Up to 3 weeks
Navina Smart: Correlation APP/irrigation parameters	Volume correlation with Anorectal Physiology Parameters (APPs) after 4 weeks in subjects who perform the anorectal physiology test, treated with Navina Smart, and using the Navina Smart App	4 weeks
Navina Smart: Correlation APP/irrigation parameters	Volume correlation with Anorectal Physiology Parameters (APPs) after 8 weeks in subjects who perform the anorectal physiology test, treated with Navina Smart, and using the Navina Smart App	8 weeks.
Navina Smart: Correlation APP/irrigation parameters	Frequency of irrigations correlation with Anorectal Physiology Parameters (APPs) up to 3 weeks from baseline in subjects who perform the anorectal physiology test, treated with Navina Smart, and using the Navina Smart App	Up to 3 weeks
Navina Smart: Correlation APP/irrigation parameters	Frequency of irrigations correlation with Anorectal Physiology Parameters (APPs) after 4 weeks in subjects who perform the anorectal physiology test, treated with Navina Smart, and using the Navina Smart App.	4 weeks
Navina Smart: Correlation APP/irrigation parameters	Frequency of irrigations correlation with Anorectal Physiology Parameters (APPs) after 8 weeks in subjects who perform the anorectal physiology test, treated with Navina Smart, and using the Navina Smart App.	8 weeks.
Navina Smart: Correlation APP/irrigation parameters	Balloon inflation correlation with Anorectal Physiology Parameters (APPs) up to 3 weeks from baseline in subjects who perform the anorectal physiology test, treated with Navina Smart, and using the Navina Smart App	Up to 3 weeks
Navina Smart: Correlation APP/irrigation parameters	Balloon inflation correlation with Anorectal Physiology Parameters (APPs) after 4 weeks in subjects who perform the anorectal physiology test, treated with Navina Smart, and using the Navina Smart App	4 weeks
Navina Smart: Correlation APP/irrigation parameters	Balloon inflation correlation with Anorectal Physiology Parameters (APPs) after 8 weeks in subjects who perform the anorectal physiology test, treated with Navina Smart, and using the Navina Smart App.	8 weeks.
Navina Smart: Correlation anorectal APP/irrigation parameters between responders/non-responders	Correlation between Anorectal Physiology Parameters (APPs), irrigations parameters (volume/frequency of irrigation and balloon inflation) and outcome of TAI treatment between responders versus non-responders in subjects who perform the anorectal physiology test, treated with Navina Smart, and using the Navina Smart App from baseline to 3 weeks. A responder is defined as an improvement equal to the 25th percentile of the change in Cleveland Clinic Constipation score when using TAI with Navina Smart.	Up to 3 weeks
Navina Smart: Correlation anorectal APP/irrigation parameters between responders/non-responders	Correlation between Anorectal Physiology Parameters (APPs), irrigations parameters (volume/frequency of irrigation and balloon inflation) and outcome of TAI treatment between responders versus non-responders in subjects who perform the anorectal physiology test, treated with Navina Smart, and using the Navina Smart App for 4 weeks. A responder is defined as an improvement equal to the 25th percentile of the change in Cleveland Clinic Constipation score when using TAI with Navina Smart.	4 weeks
Navina Smart: Correlation anorectal APP/irrigation parameters between responders/non-responders	Correlation between Anorectal Physiology Parameters (APPs), irrigations parameters(volume/frequency of irrigation and balloon inflation) and outcome of TAI treatment between responders versus non-responders in subjects who perform the anorectal physiology test, treated with Navina Smart, and using the Navina Smart App for 8 weeks. A responder is defined as an improvement equal to the 25th percentile of the change in Cleveland Clinic Constipation score when using TAI with Navina Smart.	8 weeks

Collaborators and Investigators

• Sponsor: Wellspect HealthCare
• Collaborators: Wellspect HealthCare

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Multiple Sclerosis; Sclerosis; Constipation; Neurogenic Bowel; Fecal Incontinence
• Other Study ID Numbers: NAV-0006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No