Evaluation of a Novel Electronic Transanal Irrigation System - Navina™ Smart

This study is designed as an open, prospective, single arm, multicenter study in order to investigate patient satisfaction, perception and compliance for the novel Navina Smart, a transanal irrigation (TAI) system. Approximately 30 male and female subjects who are currently practicing TAI, will be followed during a 4-week period of use of Navina Smart. Observational data on satisfaction, perception, compliance, bowel regimen, TAI therapy and TAI frequency will be collected via patient reported outcome (PRO) questionnaires.

Study Overview

• Status: Completed
• Conditions: Neurogenic Bowel
• Intervention / Treatment: Device: Navina Smart

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 171 76
    • Neurologiska kliniken, Karolinska Universitetssjukhuset Solna
• United Kingdom
  • London, United Kingdom, NW1 2BU
    • Gastrointestinal Physiology Unit, University College London Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Provision of informed consent
2. Males and females, aged 18 years and over
3. Practice TAI since at least 2 months and at least two times per week
4. Able to read and fill out a paper PRO questionnaire as judged by the principal investigator or a sub-investigator

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. Any prior rectal or colonic surgery (not including anal procedures >3 months ago, e.g. haemorrhoid excision)
7. Anal, rectal and/or colonic endoscopic polypectomy within the previous 4 weeks
8. Overt or planned pregnancy
9. Ongoing symptomatic urinary tract infection as judged by the principal investigator or a sub-investigator
10. Diagnosed psychiatric illness, considered as unstable by the principal investigator or a sub-investigator
11. Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site)
12. Previous enrolment in the present study
13. Participation in another clinical study within the last 30 days that may interfere with the present study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Navina Smart; Navina Smart will be used, during 4 weeks, for transanal irrigation (TAI).	Device: Navina Smart; Transanal irrigation at the same frequency as subject used before enrollment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire Measuring Subjects' Satisfaction of Navina Smart	PRO Questionnaire, completed by each subject after 4 weeks of using Navina Smart, collecting data on subject's assessment of satisfaction when using the study device. Satisfaction was assessed in a range of ways through different questions to be answered by each subject. For example each subject received the question "If possible, would you consider continuing using the Navina Smart system?"	4 weeks
Questionnaire Measuring Subjects' Perception of Navina Smart	PRO Questionnaire, completed by each subject after 4 weeks of using Navina Smart, collecting data on subject's assessment of perception when using the study device. For example, each subject answered the following question regarding perception: "How satisfied are you with the Navina Smart System?"	4 weeks
Questionnaire Measuring Subjects' Compliance of Navina Smart	PRO Questionnaire, completed by each subject after 4 weeks of using Navina Smart, collecting data on subject's compliance towards the study device. For example, each subject answered the following question "Did you use the Navina Smart system for 4 weeks?"	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events (AEs), Adverse Device Effects (ADEs), Serious Adverse Events (SAEs) Related to Navina Smart	Total numbers and types of AEs, ADEs and SAEs observed by the study staff or spontaneously reported from the patient.	4 weeks

Collaborators and Investigators

• Sponsor: Wellspect HealthCare

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: February 25, 2016
• First Submitted That Met QC Criteria: March 10, 2016
• First Posted (Estimate): March 16, 2016

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Neurogenic Bowel
• Other Study ID Numbers: NAV-0003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No