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Safety, Efficacy and Quality of Life of Sphinkeeper Implantation for Fecal Incontinence: Results of Mid-term Follow-up. A Multicenter Retrospective Cohort Study
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 involves placing small expandable devices into the anal sphincter area to help improve muscle function and prevent leakage. Researchers from several European hospitals followed 111 patients over three years to assess how safe and effective this treatment is, and how it affects quality of life. Most patients had not improved with other treatments like diet, medications, or pelvic floor therapy.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
January 1, 2017
Primary Completion Date
March 1, 2022
Completion Date
March 1, 2025
Last Updated
May 6, 2025
211
ACTUAL participants
Sphinkeeper™
DEVICE
Lead Sponsor
Academy of Applied Medical and Social Sciences, Poland
Collaborators
NCT05626816
NCT06532123
NCT03825575
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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