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

Academy of Applied Medical and Social Sciences, Poland

Status: Completed

Conditions: Fecal Incontinence

Treatments: Device: Sphinkeeper™

Study type: Observational

Funder types: Other

Identifiers

NCT06958497

04002025

Details and patient eligibility

About

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.

Enrollment: 211 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.