Clinical trial NCT04707976: Comparing Transanal Irrigation With Navina Smart vs. Standard Bowel Care in Patients With Multiple Sclerosis
Official title: A Randomized Controlled Trial Comparing the Efficacy of Transanal Irrigation With Navina Smart Versus Standard Bowel Care in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurogenic Bowel (Disorder)
Fecal Constipation
Fecal Incontinence
Multiple Sclerosis
Lead sponsor: Wellspect HealthCare
Sponsor class: INDUSTRY
First posted: 2021-01-13
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in fecal incontinence score.
timeFrame: 8 weeks
measure: Change in fecal constipation score
timeFrame: 8 weeks.
Secondary outcomes:
measure: Efficacy of TAI with Navina Smart vs. SBC
timeFrame: 4 weeks
measure: Efficacy of TAI with Navina Smart vs. SBC
timeFrame: 8 weeks
measure: Efficacy of TAI with Navina Smart vs. SBC
timeFrame: 4 weeks
measure: Efficacy of TAI with Navina Smart vs. SBC
timeFrame: 8 weeks
measure: Efficacy of TAI with Navina Smart vs. SBC
timeFrame: 4 weeks
measure: Efficacy of TAI with Navina Smart vs. SBC
timeFrame: 8 weeks
measure: Efficacy of TAI with Navina Smart vs. SBC
timeFrame: 4 weeks
measure: Efficacy of TAI with Navina Smart vs. SBC
timeFrame: 8 weeks
measure: Change in perception of impact of bowel symptoms on QoL
timeFrame: 8 weeks
measure: Change in NBD symptoms
timeFrame: 4 weeks and 8 weeks
measure: Change in bladder specific QoL
timeFrame: 8 weeks
measure: Study therapy adherence
timeFrame: 4 weeks and 8 weeks
measure: Frequency of UTI
timeFrame: 8 weeks
measure: Navina Smart: Correlation APP/irrigation parameters
timeFrame: Up to 3 weeks
measure: Navina Smart: Correlation APP/irrigation parameters
timeFrame: 4 weeks
measure: Navina Smart: Correlation APP/irrigation parameters
timeFrame: 8 weeks.
measure: Navina Smart: Correlation APP/irrigation parameters
timeFrame: Up to 3 weeks
measure: Navina Smart: Correlation APP/irrigation parameters
timeFrame: 4 weeks
measure: Navina Smart: Correlation APP/irrigation parameters
timeFrame: 8 weeks.
measure: Navina Smart: Correlation APP/irrigation parameters
timeFrame: Up to 3 weeks
measure: Navina Smart: Correlation APP/irrigation parameters
timeFrame: 4 weeks
measure: Navina Smart: Correlation APP/irrigation parameters
timeFrame: 8 weeks.
measure: Navina Smart: Correlation anorectal APP/irrigation parameters between responders/non-responders
timeFrame: Up to 3 weeks
measure: Navina Smart: Correlation anorectal APP/irrigation parameters between responders/non-responders
timeFrame: 4 weeks
measure: Navina Smart: Correlation anorectal APP/irrigation parameters between responders/non-responders
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Paris
country: France
facility: Hospital Tenon Service de Neuro-urologie et d'Explorations Périnéales
city: Ferrara
country: Italy
facility: Azienda Ospedaliero-Universitaria of Ferrara
state: Cona
city: Genova
country: Italy
facility: AISM Liguria Rehabilitation Centre
state: Liguria
city: Florence
country: Italy
facility: AOU Careggi
state: Tuscany
city: Bari
country: Italy
facility: Azienda Ospedaliero Universitaria Consorziale Policlinico con sede in Bari
city: Valencia
country: Spain
facility: La Fé University Hospital
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (CHUV)
city: London
country: United Kingdom
facility: University College London Hospital
Study officials:
affiliation: Département des neurosciences cliniques Centre Hospitalier Universitaire Vaudois (CHUV); Lausanne
name: Brigitte Schürch, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Unidad de Esclerosis Multiple - Servicio de Neurologica La Fé University Hospital; Valencia
name: Bonaventura Casanova, Dr.
role: PRINCIPAL_INVESTIGATOR
References: