Clinical
Evidence
Clinical Evidence
Study objectives
- Primary:
To demonstrate the safety of the ForConti Fecal Incontinence Management System (FIMS) - Secondary:
To demonstrate improvements in fecal incontinence management with the use of Contix™.
Duration
Duration of the study for each patient was up to 7 weeks, including telephone follow-up.
- Adjustment Phase (up to 1 week):
use of ForConti System, daily bowel records - Control Phase (weeks 2-3):
no use of ForConti System, daily bowel records - Treatment Phase (weeks 4-5):
Use of ForConti System, daily bowel records - Telephone Follow-up (weeks 6-7)
The primary end-point of the pilot study was achieved successfully, demonstrating the safety of the ForConti device in the intended population. No safety issues were identified in the study.
The results demonstrate that in those patients able to use the device as intended, Contix™ was effective in preventing ABL during the treatment period with the device. Using the Contix™ was mostly comfortable, reduced the incidence of fecal leakage, aided in preventing fecal incontinence, and positively affected the users’ feeling of confidence.
Leakage, Urgency and Incontinence percentage
per patient, for Patients 002,003 & 005
Number of device insertions per patient
Hours of use per patient*
Pain level during insertion, use and removal of the device - per patient*
Patient Testimonial
patient: was not able to go swimming for the last two years, with our device she was able to resume this activity and commented that she ”felt great!!!”
Patient Testimonial
patient: was very happy with the device performance and commented that “he never felt better”