Treatment of Anal Incontinence With Intersphincteric Implants

Study Overview
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Brief Summary
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The purpose of this study is to determine whether treatment with intersphincteric implants is an effective and safe treatment option for patients with anal incontinence

Detailed Description
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Treatment of anal incontinence (AI) remains a challenge - although conservative treatment can reduce the severity of many patients' AI, many continue to experience symptoms that severly affect their quality of life and ability to function properly both socially and professionally. The level of AI is measured with the St Marks score (ranging from 0-24 where zero is complete continence). Some patients with AI are shown to have defects in the anal sphincters (i.e. traumatic lesions post partum) and can be helped with reconstructive surgery. These procedures are effective but carry substantial risk for postoperative infection, and the healing process is painful. One of the main treatment options for anal incontinence today is Sacral Nerve Stimulation (SNS), which is an effective but invasive and expensive treatment with a rather high level of infection. It is normally performed in two separate sessions and require life-long follow up and new surgical procedures every 6-7 years. Historically artificial anal sphincters have been studied and shown to be effective but with high rates of infections leading to removal of the device. In more recent years studies have instead focused on bulking agents (injection of i.e. silicone in the submucosal space with the aim to increase the resting pressure of the anal canal), but the effect seems to be limited and the agents injected are rapidly resorbed by the body. Treatment with intersphincteric implants is a novel treatment option for these patients. Available studies have shown good results regarding effect and a low frequence of postoperative infections. The implants rarely dislocate and are not resorbed by the body, which contributes to their long-term effectiveness. The operation is performed under a short general anaesthesia and in available studies the postoperative symptoms are few. The first technique described was called Gatekeeper (six implants), and this has since been completed by the Sphinkeeper (ten implants), which is the focus of the present study.

Official Title
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Treatment of Anal Incontinence Using Intersphincteric Implants (SphinKeeper)

Conditions
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Anal Incontinence, Fecal Incontinence

Intervention / Treatment
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* Device: Sphinkeeper


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent. Subject must be at least 18 years of age Subject must have a St Marks score of at least 11 Subject must be able to comply with study and study follow-up requirements. Exclusion Criteria: Subjects with Crohn's disease or Ulcerative colitis Subject has (a history of) malignancy in the rectum or anal canal Subject has an ongoing treatment with chemotherapy (all indications) Subject has verified active anal fistula(e) Subject is unable or unwilling to provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intersphincteric implants<br>Treatment with intersphincteric implants in the anal sphincter using Sphinkeeper | Device: Sphinkeeper<br>* Intersphincteric implants in the anal sphincter<br>* Other names: Intersphincteric implants;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of anal incontinence | Reduction in St Marks score | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative infection | Rate of infection i.e. formation of abcess within the first year of treatment. | 12 months | 
| Change from baseline in pain scores on the VAS at 3 and 12 months. | VAS (Visual Analog Scale) | Baseline, 3 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sphinkeeper, Intersphincteric implants, Gatekeeper