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Completed

NCT Number: NCT06958497

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

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.

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Key information

Conditions

Fecal Incontinence Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Number of Fecal Incontinence Episodes per Week

    Time frame: 3 years

    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

  2. Change in Number of Soiling Episodes per Week

    Time frame: 3 years

    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. Change in Time to Postpone Defecation

    Time frame: 3 years

    The mean change from baseline in the maximum time participants are able to postpone defecation at 3-year follow-up.

    Unit of Measure: Minutes

  4. Change in Cleveland Clinic Incontinence Score (CCIS)

    Time frame: 3 years

    The mean change from baseline in the CCIS at 3-year follow-up. Unit of Measure: Points on the CCIS scale (0-20)

  5. Change in Vaizey Incontinence Score

    Time frame: 3 years

    The mean change from baseline in the Vaizey score at 3-year follow-up. Unit of Measure: Points on the Vaizey scale (0-24)

Secondary outcomes

  1. Change in Fecal Incontinence Quality of Life (FIQoL) Score

    Time frame: 3 years

    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).

Sponsors and collaborators

Lead sponsor

Academy of Applied Medical and Social Sciences, Poland

Other

Collaborators

  • Imperial College London
  • St Mark's Hospital Foundation
  • The Royal London Hospital, UK
  • University of Barcelona
  • University of Campania Luigi Vanvitelli
  • Vienna University Hospital, Austria

Registry information

Official study title

Safety, Efficacy and Quality of Life of Sphinkeeper Implantation for Fecal Incontinence: Results of Mid-term Follow-up. A Multicenter Retrospective Cohort Study

Important dates

Study start
2017
Primary completion
2022
Study completion
2025
First posted
May 6, 2025
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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