Safety, Efficacy and Quality of Life of Sphinkeeper Implantation for Fecal Incontinence

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.

Study Overview

• Status: Completed
• Conditions: Fecal Incontinence
• Intervention / Treatment: Device: Sphinkeeper™

• Study Type: Observational
• Enrollment (Actual): 211

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Number of Fecal Incontinence Episodes per Week	The mean change from baseline in the number of fecal incontinence episodes per week at 3-year follow-up. Unit of Measure: Episodes per week	3 years
Change in Number of Soiling Episodes per Week	The mean change from baseline in the number of soiling episodes per week at 3-year follow-up. Unit of Measure: Episodes per week	3 years
Change in Time to Postpone Defecation	The mean change from baseline in the maximum time participants are able to postpone defecation at 3-year follow-up. Unit of Measure: Minutes	3 years
Change in Cleveland Clinic Incontinence Score (CCIS)	The mean change from baseline in the CCIS at 3-year follow-up. Unit of Measure: Points on the CCIS scale (0-20)	3 years
Change in Vaizey Incontinence Score	The mean change from baseline in the Vaizey score at 3-year follow-up. Unit of Measure: Points on the Vaizey scale (0-24)	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fecal Incontinence Quality of Life (FIQoL) Score	Evaluation of the impact of the Sphinkeeper procedure on quality of life, assessed by the Fecal Incontinence Quality of Life (FIQoL) Scale. The FIQoL Scale consists of 29 items across four domains (Lifestyle, Coping/Behavior, Depression/Self-Perception, Embarrassment). Each item is scored from 1 to 4, with higher scores indicating a better quality of life. Domain scores and a total score are calculated; higher scores reflect better functioning and reduced impact of fecal incontinence. Unit of Measure: Points on the FIQoL Scale (range: 1-4 per item; total scores vary depending on domain aggregation).	3 years

Collaborators and Investigators

• Sponsor: Academy of Applied Medical and Social Sciences, Poland
• Collaborators: Imperial College London; St Mark's Hospital Foundation; University of Barcelona; University of Campania Luigi Vanvitelli; Vienna University Hospital, Austria; The Royal London Hospital, UK

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: April 21, 2025
• First Submitted That Met QC Criteria: April 26, 2025
• First Posted (Actual): May 6, 2025

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: April 26, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: 04002025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No