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

NCT06958497 | Completed

• 1 other identifier: 04002025
• Study Type: observational
• Target: 211
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Change in Fecal Incontinence Quality of Life (FIQoL) Score

  3 years

Interventions

Sphinkeeper™ DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: May 6, 2025
• Study Start: January 1, 2017
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-04