Clinical Trial: An Open, Qualitative, Prospective, Multicenter Trial of a Novel Transanal Irrigation System in Spinal Cord Injured Patients.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: An Open, Qualitative, Prospective, Multicenter Trial of a Novel Transanal Irrigation System in Spinal Cord Injured Patients.

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 Summary: 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, and Norway.
Sponsor: Dentsply International

Current Primary Outcome: Change in neurogenic bowel disfunction symptoms. [ Time Frame: 3 months ]

1. The primary objective of this study is to evaluate change in neurogenic bowel dysfunction symptoms between baseline and 3 months use of the Navina™ Smart system, as measured by a patient friendly version of the validated instrument NBD Score.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change of QoL status [ Time Frame: Baseline, 3-months, 12-months ]
    To investigate the change of QoL status in the selected patient population (absolute values)
  • NBD symptoms [ Time Frame: 6-months, 9-months, 12-months ]
    To investigate NBD symptoms after 6, 9 and 12 months use of Navina Smart system
  • Product use compliance. [ Time Frame: 3-months, 6-months, 9-months, and 12-months ]
    Study product use compliance (is TAI still performed using the study device).
  • Patient satisfaction assessed through patient reported outcome (PRO) variables. [ Time Frame: 3-months and 12-months ]
    To investigate patient perception and satisfaction of bowel management including TAI therapy and use of the Navina Smart system.
  • Frequency of urinary tract infection (UTI). [ Time Frame: 3-months and 12-months ]
    Investigate frequency of UTI using patient reported outcome (PRO) variables.
  • Health economic analysis utilizing QoL data. [ Time Frame: Baseline, 3-months, and 12-months. ]
    To perform health economic analyses using QoL data (EQ-5D).
  • Health economic analysis utilizing patient reported outcome (PRO) variables. [ Time Frame: Baseline, 3-months, and 12-months. ]
    To perform health economic analyses using PRO variables.
  • Thematic analysis of interview data. [ Time Frame: Baseline, 3-months, and 12-months (or at end of treatment period). ]
    To understand individual experience of initiating and using TAI for neurogenic bowel dysfunction.
  • Thematic analysis of interview data. [ Time Frame: Baseline, 3-months, and 12-months (or at end of treatment period). ]
    To explore individual perceptions of using TAI compared with other conservative treatments for neurogenic bowel dysfunction.
  • Thematic analysis of interview data. [ Time Frame: Baseline, 3-months, and 12-months (or at end of treatment period). ]
    To explore what influences individuals to continue with or stop using TAI for neurogenic bowel dysfunction.
  • Incidence of adverse events, serious adverse events, and adverse device effects. [ Time Frame: 3-months, 6-months, 9-months, 12-months ]
    To evaluate short- and long-term safety of the product and therapy by assessing adverse events, serious adverse events, adverse device effects.


Original Secondary Outcome:

  • Change of QoL status [ Time Frame: Baseline, 3-months, 12-months ]
    To investigate the change of QoL status in the selected patient population (absolute values)
  • NBD symptoms [ Time Frame: 6-months, 9-months, 12-months ]
    To investigate NBD symptoms after 6, 9 and 12 months use of Navina Smart system
  • Product use compliance. [ Time Frame: 3-months, 6-months, 9-months, and 12-months ]
    Study product use compliance (is TAI still performed using the study device).
  • Patient satisfaction assessed through patient reported outcome (PRO) variables. [ Time Frame: 3-months and 12-months ]
    To investigate patient perception and satisfaction of bowel management including TAI therapy and use of the Navina Smart system.
  • Frequency of urinary tract infection (UTI). [ Time Frame: 3-months and 12-months ]
    Investigate frequency of UTI using patient reported outcome (PRO) variables.
  • Health economic analysis utilizing QoL data. [ Time Frame: Baseline, 3-months, and 12-months. ]
    To perform health economic analyses using QoL data (EQ-5D).
  • Health economic analysis utilizing patient reported outcome (PRO) variables. [ Time Frame: Baseline, 3-months, and 12-months. ]
    To perform health economic analyses using PRO variables.
  • Safety objectives [ Time Frame: 3-months, 6-months, 9-months, 12-months ]
    To evaluate short- and long-term safety of the product and therapy by assessing adverse events, serious adverse events, adverse device effects.


Information By: Dentsply International

Dates:
Date Received: November 7, 2016
Date Started: October 2016
Date Completion:
Last Updated: March 20, 2017
Last Verified: March 2017