Comparing Transanal Irrigation With Navina Smart vs. Standard Bowel Care in Patients With Multiple Sclerosis
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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.
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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.
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Outcome Measures
Primary Outcome Measures
- Change in fecal incontinence score. [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 [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 Outcome Measures
- Efficacy of TAI with Navina Smart vs. SBC [4 weeks]
Absolute change in Wexner fecal incontinence score at 4 weeks relative to Baseline in the TAI arm, compared to the SBC arm.
- Efficacy of TAI with Navina Smart vs. SBC [8 weeks]
Absolute change in Wexner fecal incontinence score at 8 weeks relative to Baseline in the TAI arm, compared to the SBC arm.
- Efficacy of TAI with Navina Smart vs. SBC [4 weeks]
Absolute change in Cleveland Clinic constipation score at 4 relative to Baseline in the TAI arm, compared to the SBC arm.
- Efficacy of TAI with Navina Smart vs. SBC [8 weeks]
Absolute change in Cleveland Clinic constipation score at 4 relative to Baseline in the TAI arm, compared to the SBC arm.
- Efficacy of TAI with Navina Smart vs. SBC [4 weeks]
Relative change in Wexner fecal incontinence score at 4 weeks relative to Baseline in the TAI arm, compared to the SBC arm.
- Efficacy of TAI with Navina Smart vs. SBC [8 weeks]
Relative change in Wexner fecal incontinence score at 4 weeks relative to Baseline in the TAI arm, compared to the SBC arm.
- Efficacy of TAI with Navina Smart vs. SBC [4 weeks]
Relative change in Cleveland Clinic constipation score at 4 weeks relative to Baseline in the TAI arm, compared to the SBC arm
- Efficacy of TAI with Navina Smart vs. SBC [8 weeks]
Relative change in Cleveland Clinic constipation score at 4 weeks relative to Baseline in the TAI arm, compared to the SBC arm
- Change in perception of impact of bowel symptoms on QoL [8 weeks]
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.
- Change in NBD symptoms [4 weeks and 8 weeks]
Absolute and relative change in NBD score between Baseline and 4 and 8 weeks in the Navina arm, compared to the SBC arm.
- Change in bladder specific QoL [8 weeks]
Absolute and relative change in SF-Qualiveen questionnaire between Baseline and 8 weeks in the TAI arm, compared to the SBC arm.
- Study therapy adherence [4 weeks and 8 weeks]
Number of subjects using Navina Smart or SBC at 4 weeks and 8 weeks treatment, as measured by a single question.
- Frequency of UTI [8 weeks]
Number of UTIs requiring antibiotic treatment 8 weeks prior study start (Baseline) and at 8 weeks after treatment (Visit 2), as reported by subject.
- Navina Smart: Correlation APP/irrigation parameters [Up to 3 weeks]
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.
- Navina Smart: Correlation APP/irrigation parameters [4 weeks]
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
- Navina Smart: Correlation APP/irrigation parameters [8 weeks.]
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
- Navina Smart: Correlation APP/irrigation parameters [Up to 3 weeks]
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
- Navina Smart: Correlation APP/irrigation parameters [4 weeks]
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.
- Navina Smart: Correlation APP/irrigation parameters [8 weeks.]
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.
- Navina Smart: Correlation APP/irrigation parameters [Up to 3 weeks]
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
- Navina Smart: Correlation APP/irrigation parameters [4 weeks]
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
- Navina Smart: Correlation APP/irrigation parameters [8 weeks.]
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.
- Navina Smart: Correlation anorectal APP/irrigation parameters between responders/non-responders [Up to 3 weeks]
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.
- Navina Smart: Correlation anorectal APP/irrigation parameters between responders/non-responders [4 weeks]
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.
- Navina Smart: Correlation anorectal APP/irrigation parameters between responders/non-responders [8 weeks]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
For inclusion in the study, subjects must fulfil all of the following criteria:
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Provision of informed consent.
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Female or male aged 18 years or above.
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Established diagnosis of MS according to McDonald criteria.
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Patients with bowel symptoms post-dating and related to a diagnosis of MS.
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Patients suffering from NBD symptoms defined by Wexner feacal incontinence score ≥10 and/or Cleveland Clinic constipation score ≥10 confirmed at Baseline.
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Only TAI treatment naïve patient (not having previously used any particular TAI system).
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Judged eligible for TAI as per standardized treatment pathway.
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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:
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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.
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Untreated rectal impaction.
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Other significant neurological diseases (defined as all neurological diseases except for minor functional neurological syndromes or non-MS related neuro complications).
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Opioid consumption ≤24 hours prior enrolment.
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Previous colorectal surgery (including haemorrhoidectomy and fistulotomy), sphincter injury, perianal sepsis, rectal prolapse.
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Performed endoscopic polypectomy within 4 weeks prior enrolment.
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Ongoing, confirmed pregnancy or lactation.
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Any neuromodulation that can affect the pelvic organ function.
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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).*
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Current treatment with anticoagulants (exception acetylsalicylic acid or clopidogrel).
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Current treatment with long-term systemic steroid medication (exception inhalation agents and/or local topical treatment).
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Current treatment of prokinetics.
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Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare and site personnel).
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Previous enrolment in the present study.
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Simultaneous participation in another clinical study that may interfere with the present study as judged by the investigator.
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Expected severe non-compliance to protocol as judged by the investigator.
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Any other condition, as judged by the investigator, which might make follow-up or investigations inappropriate.
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Any patient that according to the Declaration of Helsinki is unsuitable for enrolment.
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Aarhus University Hospital | Aarhus | Denmark | ||
2 | Hospital Tenon Service de Neuro-urologie et d'Explorations Périnéales | Paris | France | 75020 | |
3 | La Fé University Hospital | Valencia | Spain | 46026 | |
4 | Centre Hospitalier Universitaire Vaudois (CHUV) | Lausanne | Switzerland | 1011 | |
5 | University College London Hospital | London | United Kingdom |
Sponsors and Collaborators
- Dentsply International
- Wellspect HealthCare
Investigators
- Principal Investigator: 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NAV-0006