Clinical trial NCT06958497: Safety, Efficacy and Quality of Life of Sphinkeeper Implantation for Fecal Incontinence
Official title: Safety, Efficacy and Quality of Life of Sphinkeeper Implantation for Fecal Incontinence: Results of Mid-term Follow-up. A Multicenter Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fecal Incontinence
Lead sponsor: Academy of Applied Medical and Social Sciences, Poland
Sponsor class: OTHER
Collaborators: name: University of Campania Luigi Vanvitelli
name: Vienna University Hospital, Austria
name: University of Barcelona
name: St Mark's Hospital Foundation
name: Imperial College London
name: The Royal London Hospital, UK
First posted: 2025-05-06
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: among all the patients with FI assessed for eligibility, were included in this study the subjects over 18 years of age, affected by clinical FI (defined as at least one incontinence episode per week reported for a period of time longer than six months), who were refractory to all standard conservative measures (pharmacologic, behavioral, and pelvic floor rehabilitation) and who showed, at endosonographic evaluation, intact anal sphincters or internal or external or combined internal and external sphincter defects extending for no more of 120 grades of anal circumference.

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 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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Change in Number of Fecal Incontinence Episodes per Week
timeFrame: 3 years
measure: Change in Number of Soiling Episodes per Week
timeFrame: 3 years
measure: Change in Time to Postpone Defecation
timeFrame: 3 years
measure: Change in Cleveland Clinic Incontinence Score (CCIS)
timeFrame: 3 years
measure: Change in Vaizey Incontinence Score
timeFrame: 3 years
Secondary outcomes:
measure: Change in Fecal Incontinence Quality of Life (FIQoL) Score
timeFrame: 3 years
Other outcomes:
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