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

NCT04707976 | Recruiting

• 1 other identifier: NAV-0006
• Study Type: interventional
• Target: 92
• Locations: 6 countries
• Sites: 9

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (25)

• Efficacy of TAI with Navina Smart vs. SBC

  4 weeks

• Efficacy of TAI with Navina Smart vs. SBC

  8 weeks

• Efficacy of TAI with Navina Smart vs. SBC

  4 weeks

• Efficacy of TAI with Navina Smart vs. SBC

  8 weeks

• Efficacy of TAI with Navina Smart vs. SBC

  4 weeks

Study Arms (2)

Navina Smart

EXPERIMENTAL

An electronic medical device to perform transanal irrigation. Treatment period 8 weeks.

Device: Navina Smart

Standard Bowel Care

ACTIVE COMPARATOR

Supportive bowel care without using irrigation.

Other: Standard Bowel Care

Interventions

Navina Smart DEVICE

CE-marked NavinaTM Smart including Navina Smart App.

Navina Smart

Standard Bowel Care OTHER

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.

Standard Bowel Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).\*
• Current treatment with anticoagulants (exception acetylsalicylic acid or clopidogrel).
• Current treatment with long-term systemic steroid medication (exception inhalation agents and/or local topical treatment).
• Current treatment of prokinetics.
• Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare and site personnel).
• Previous enrolment in the present study.
• Simultaneous participation in another clinical study that may interfere with the present study as judged by the investigator.

Sponsors & Collaborators

• Wellspect HealthCare: lead

Study Sites (9)

Aarhus University Hospital

Aarhus, Denmark

RECRUITING

Hospital Tenon Service de Neuro-urologie et d'Explorations Périnéales

Paris, 75020, France

RECRUITING

Azienda Ospedaliero-Universitaria of Ferrara

Ferrara, Cona, 44124, Italy

RECRUITING

AISM Liguria Rehabilitation Centre

Genoa, Liguria, 16149, Italy

RECRUITING

AOU Careggi

Florence, Tuscany, 510 34, Italy

RECRUITING

Azienda Ospedaliero Universitaria Consorziale Policlinico con sede in Bari

Bari, 70124, Italy

RECRUITING

La Fé University Hospital

Valencia, 46026, Spain

RECRUITING

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, 1011, Switzerland

WITHDRAWN

University College London Hospital

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neurogenic Bowel; Fecal Incontinence; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Brigitte Schürch, Prof.

  Département des neurosciences cliniques Centre Hospitalier Universitaire Vaudois (CHUV); Lausanne

  PRINCIPAL INVESTIGATOR

• Bonaventura Casanova, Dr.

  Unidad de Esclerosis Multiple - Servicio de Neurologica La Fé University Hospital; Valencia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wellspect HealthCare

CONTACT

+46 31 376 40 00; mace@wellspect.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: January 13, 2021
• Study Start: December 1, 2020
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: July 11, 2024

Record last verified: 2024-07

Locations

GB (1); IT (4); DK (1); ES (1); CH (1); FR (1)