Clinical trial NCT02979808: An Open, Qualitative, Prospective, Multicenter Trial of a Novel Transanal Irrigation System in Spinal Cord Injured Patients.
Official title: An Open, Qualitative, Prospective, Multicenter Trial of a Novel Transanal Irrigation System in Spinal Cord Injured Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurogenic Bowel
Lead sponsor: Dentsply Sirona Inc.
Sponsor class: INDUSTRY
Collaborators: name: Wellspect HealthCare
First posted: 2016-12-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is designed as an open, prospective, non-controlled, qualitative, multicentre study of a novel transanal irrigation system performed in a population of 150 subjects suffering from spinal cord injury and confirmed neurological bowel dysfunction. The study is expected to last for a total of 1 year (treatment period) with a planned 12- month recruitment period and three scheduled site visits.

Detailed description: This study will be conducted in multiple countries, all outside of the United States. The study is approved by oversight authorities in the United Kingdom, Germany, Spain, Sweden, Denmark, Norway, France, and Italy

Eligibility criteria: Inclusion Criteria:

1. Provision of informed consent.
2. Male or female aged 18 years or older.
3. Patient with previously confirmed chronic spinal cord injury, either:

   1. Traumatic; at any level and any completeness of injury and ASIA grade classification, or
   2. Non-traumatic; due to infection, inflammation (i.e.; transverse myelitis or ischaemic myelitis), compromised blood supply, a post-ischemic state, etc.
4. At least 3 months post spinal cord injury at time of consent.
5. NBD score ≥10, confirmed at Baseline .
6. Only TAI treatment - naïve patient (not having previously used any particular transanal irrigation system, e.g. Peristeen®).
7. Confirmed NBD refractory to conservative therapy and judged eligible for transanal irrigation as per standardised treatment pathway 18.
8. Able to handle smartphone/tablet.

Exclusion Criteria:

1. Any confirmed or suspected diagnosis of anal or rectal 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. Any radiotherapy to the pelvis.
4. Any current treatment with anticoagulants (not including aspirin or clopidogrel).
5. Any current treatment with long-term systemic steroid medication (not including inhalation agents and/or local topical treatment).
6. Current use of prokinetics.
7. Any prior rectal or colonic surgery (not including anal procedures \>3 months ago, e.g. haemorrhoid excision).
8. Anal, rectal and/or colonic endoscopic polypectomy within the previous 4 weeks.
9. Overt or planned pregnancy.
10. Ongoing symptomatic UTI as judged by investigator.
11. Diagnosed psychiatric illness, considered as unstable by the investigator.
12. Diagnosed with MS.
13. Involvement in the planning and conduct of the study (applies to both WHC staff and staff at the study site).
14. Previous enrolment in the present study.
15. Simultaneous participation in another clinical study that may interfere with the present study.

Primary outcomes:
measure: Change in neurogenic bowel disfunction symptoms.
timeFrame: 3 months
Secondary outcomes:
measure: Change of QoL status
timeFrame: Baseline, 3-months, 12-months
measure: NBD symptoms
timeFrame: 6-months, 9-months, 12-months
measure: Product use compliance.
timeFrame: 3-months, 6-months, 9-months, and 12-months
measure: Patient satisfaction assessed through patient reported outcome (PRO) variables.
timeFrame: 3-months and 12-months
measure: Frequency of urinary tract infection (UTI).
timeFrame: 3-months and 12-months
measure: Health economic analysis utilizing QoL data.
timeFrame: Baseline, 3-months, and 12-months.
measure: Health economic analysis utilizing patient reported outcome (PRO) variables.
timeFrame: Baseline, 3-months, and 12-months.
measure: Thematic analysis of interview data.
timeFrame: Baseline, 3-months, and 12-months (or at end of treatment period).
measure: Thematic analysis of interview data.
timeFrame: Baseline, 3-months, and 12-months (or at end of treatment period).
measure: Thematic analysis of interview data.
timeFrame: Baseline, 3-months, and 12-months (or at end of treatment period).
measure: Incidence of adverse events, serious adverse events, and adverse device effects.
timeFrame: 3-months, 6-months, 9-months, 12-months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Nantes
country: France
facility: Hôpital St Jacques
state: Rennes
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka Gmbh
city: Hamburg
country: Germany
facility: BG-Klinikum Hamburg
city: Imola
country: Italy
facility: Montecatone Rehabilitation Institute, Università di Bologna
state: Bologna
city: Firenze
country: Italy
facility: Azienda Ospedaliera- Universitaria Careggi
state: Florence
city: Nesoddtangen
country: Norway
facility: Sunnaas Sykehus HF
city: Barcelona
country: Spain
facility: Unidad de Lesionados Medulares Hospital Traumatología
city: Coruna
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: Stockholm
country: Sweden
facility: Neurologiska kliniken, Avd R18 Karolinska Universitetssjukhuset, Solna
city: London
country: United Kingdom
facility: Gastrointestinal Physiology Unit, University College London Hospital
Study officials:
References:
citation: Emmanuel A, Kurze I, Krogh K, Ferreiro Velasco ME, Christensen P, Del Popolo G, Bazzocchi G, Hultling C, Perrouin Verbe B, Bothig R, Glott T, Gonzalez Viejo MA. An open prospective study on the efficacy of Navina Smart, an electronic system for transanal irrigation, in neurogenic bowel dysfunction. PLoS One. 2021 Jan 29;16(1):e0245453. doi: 10.1371/journal.pone.0245453. eCollection 2021.