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

Wellspect HealthCare92 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neurogenic Bowel (Disorder)Fecal Constipation Fecal Incontinence Multiple Sclerosis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (9)

Aarhus University Hospital

Aarhus, Denmark

RECRUITING

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

Paris, France

RECRUITING

Azienda Ospedaliero-Universitaria of Ferrara

Ferrara, Cona, Italy

RECRUITING

AISM Liguria Rehabilitation Centre

Genoa, Liguria, Italy

RECRUITING

AOU Careggi

Florence, Tuscany, Italy

RECRUITING

Azienda Ospedaliero Universitaria Consorziale Policlinico con sede in Bari

Bari, Italy

RECRUITING

La Fé University Hospital

Valencia, Spain

RECRUITING

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Switzerland

WITHDRAWN

University College London Hospital

London, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 8 weeks.

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 8 weeks