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

NCT06958497 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 211

Last updated 2025-05-06

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • University of Campania Luigi Vanvitelli

    collaborator OTHER

  • Vienna University Hospital, Austria

    collaborator UNKNOWN

  • University of Barcelona

    collaborator OTHER

  • St Mark's Hospital Foundation

    collaborator OTHER

  • Imperial College London

    collaborator OTHER

  • The Royal London Hospital, UK

    collaborator UNKNOWN

  • Academy of Applied Medical and Social Sciences, Poland

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2022-03-31
Completion
2025-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06958497 on ClinicalTrials.gov