Status:
COMPLETED
Safety, Efficacy and Quality of Life of Sphinkeeper Implantation for Fecal Incontinence
Lead Sponsor:
Academy of Applied Medical and Social Sciences, Poland
Collaborating Sponsors:
University of Campania Luigi Vanvitelli
Vienna University Hospital, Austria
Conditions:
Fecal Incontinence
Eligibility:
All Genders
18+ years
Brief Summary
This study evaluated a treatment called Sphinkeeper™ implantation for people suffering from fecal incontinence, a condition where individuals are unable to control their bowel movements. The procedure...
Eligibility Criteria
Inclusion
- Adults diagnosed with clinical fecal incontinence (FI), defined as experiencing at least one incontinence episode per week for a duration exceeding six months.
- Refractory to all standard conservative treatments, including:
- Pharmacologic therapy
- Behavioral interventions
- Pelvic floor rehabilitation
- Endoanal ultrasonography indicating:
- Intact internal and external anal sphincters, or
- Internal, external, or combined sphincter defects involving no more than 120 degrees of the anal circumference.
Exclusion
- Presence of inflammatory bowel disease with anorectal involvement.
- Diagnosis of anorectal cancer.
- Evidence of perianal sepsis.
- Endoanal ultrasound detection of sphincter defects extending over more than 120 degrees of the internal or external sphincter, or both.
- Prior treatment with sacral neuromodulation.
Key Trial Info
Start Date :
January 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2025
Estimated Enrollment :
211 Patients enrolled
Trial Details
Trial ID
NCT06958497
Start Date
January 1 2017
End Date
March 1 2025
Last Update
May 6 2025
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