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

NCT ID: NCT06958497

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 211 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2025-03-31

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.

Conditions

Fecal Incontinence

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Sphinkeeper™

The procedure was performed under spinal anesthesia, with the patients in lithotomy position. Ten 2-mm perianal skin incisions were made 1-2 cm from the anal margin (i.e., 0.5-1 cm from the intersphinteral sulcus), equidistant one each other, around the entire anal circumference, to allow implantation of 10 prostheses using a specifically designed delivery system (THD Sphinkeeeper Delivery System, THD Sp, Correggio, Italy). The introducer was placed through each skin incision in the intersphincteric space where the prostheses were delivered at a level below the puborectalis muscle. All of the steps were verified by palpation and direct vision using the Eisenhammer anal speculum. Patients were discharged on the same day and recommended to avoid any trauma or sexual practice during the first 48 hours after implantation. A 5-day course of antibiotics was also prescribed.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role: collaborator

Vienna University Hospital, Austria

UNKNOWN

Sponsor Role: collaborator

University of Barcelona

OTHER

Sponsor Role: collaborator

St Mark's Hospital Foundation

OTHER

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: collaborator

The Royal London Hospital, UK

UNKNOWN

Sponsor Role: collaborator

Academy of Applied Medical and Social Sciences, Poland

OTHER

Sponsor Role: lead

Responsible Party

Luigi Marano

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

04002025

Identifier Type: -

Identifier Source: org_study_id