Fecal IncontinenceNCT06958497
Safety, Efficacy and Quality of Life of Sphinkeeper Implantation for Fecal Incontinence
An observational study of Fecal Incontinence, run by Academy of Applied Medical and Social Sciences, Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Sphinkeeper™
- Type of treatment
- Medical device
- How many people
- 211 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Safety, Efficacy and Quality of Life of Sphinkeeper Implantation for Fecal Incontinence: Results of Mid-term Follow-up. A Multicenter Retrospective Cohort Study
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
- Being tested
- Sphinkeeper™
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 3 years
Secondary outcomes (1)
Change in Fecal Incontinence Quality of Life (FIQoL) Score
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).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study startJan 2017
- Primary completionMar 2022
- Study completionMar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academy of Applied Medical and Social Sciences, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Campania Luigi Vanvitelli, Vienna University Hospital, Austria, University of Barcelona, St Mark's Hospital Foundation, Imperial College London, The Royal London Hospital, UK
- Responsible party
- Principal investigator, Luigi Marano, Academy of Applied Medical and Social Sciences, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958497
- Sponsor's protocol ID
- 04002025
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2025
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Efficacy and Quality of Life of Sphinkeeper Implantation for Fecal Incontinence: Results of Mid-term Follow-up. A Multicenter Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06958497
- Acronym / sponsor ID
- 04002025
- Conditions
- Fecal Incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Academy of Applied Medical and Social Sciences, PolandUniversity, hospital or other
- Collaborators
- University of Campania Luigi Vanvitelli, Vienna University Hospital, Austria, University of Barcelona, St Mark's Hospital Foundation, Imperial College London, The Royal London Hospital, UK
- Study start
- Jan 2017 (actual)
- Primary completion
- Mar 2022 (actual)
- Study completion
- Mar 2025 (actual)
- First posted
- 6 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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:
- Endoanal ultrasonography indicating:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | – |
Primary outcome
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
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
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
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)
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)
1 secondary outcome
Change in Fecal Incontinence Quality of Life (FIQoL) Score
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fecal Incontinence, run by Academy of Applied Medical and Social Sciences, Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Number of Fecal Incontinence Episodes per Week (time frame: 3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.