Fecal Incontinence
Conditions
Keywords
Surgical Treatment, Implant
Brief summary
The purpose of the clinical investigation is to verify that the device under investigation (SimplyFI) is appropriate to significantly improve fecal incontinence in patients in whom its use is indicated.
Interventions
PROCEDUREMedical Device (SimplyFI)
Implantation a non-active medical device (SimplyFI) for the treatment of chronic fecal incontinence.
Sponsors
A.M.I. Agency for Medical Innovations GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Both male and female subjects * Age ≥ 18 years, \<85 years * Subject has failed standard conservative therapy for fecal incontinence (at least 6 months) * Subject is a surgical candidate * Subject is willing and able to cooperate with follow-up examinations * Subject has been informed of the study procedures and the treatment and has signed an informed consent form and provided authorization to use and disclose information for research purposes.
Exclusion criteria
* Treatment with another investigational drug or investigational device * Unable to understand study requirements or is unable to comply with follow-up schedule * Contraindicated according to the instruction for use of the device * Pregnancy or nursing, or plans to become pregnant * History of significant obstructed defecation or other significant chronic defecatory motility disorders * Current, external full thickness rectal prolapse or vaginal prolapse * Inflammatory Bowel Disease * Irritable Bowel Syndrome * Systemic disease as source of FI (scleroderma, neurologic disorders, Crohn's) * Active pelvic infection * Chronic diarrhea * Medical history of anal, rectal, or colon cancer * Prior anterior resection of the rectum * Medical history of pelvic radiation therapy * Significant scarring of the recto-vaginal septum, a permanent implant in the rectovaginal septum, or a history of recto-vaginal fistula * Previous anorectal posterior compartment surgery * History of complex anal fistula
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety-related complications and adverse events | 12 months | The primary endpoint is safety-related complications and adverse events during follow-up until 12 months after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cure of fecal incontinence (Fecal Incontinence Quality of Life Scale (FIQLs)) | 12 months | The secondary endpoint is to evaluate the change of fecal incontinence assessed by validated scores (changes from baseline to 1 week, 1 months, 3 months, 6 months) until 12 months after surgery. Fecal Incontinence Quality of Life scale (all subscale scores 1-4). Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. Scale scores are the average (mean) response to all items in the scale. |
| Quality of Life (St. Mark's incontinence score (SMIS)) | 12 months | The secondary endpoint is to evaluate the change of Quality of Life assessed by validated scores (changes from baseline to 1 week, 1 months, 3 months, 6 months) until 12 months after surgery. St. Marks incontinence score contains 7 questions, and a higher total score means a worse outcome |
Countries
Austria, Germany, Spain
Contacts
PRINCIPAL_INVESTIGATORStefan Riss, Prof. PD Dr.
Medical University Vienna
PRINCIPAL_INVESTIGATORJosé Manuel Devesa Múgica, Dr.
Hospital Ruber Internacional
Outcome results
None listed