Anal Incontinence, Fecal Incontinence
Conditions
Keywords
Sphinkeeper, Intersphincteric implants, Gatekeeper
Brief summary
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
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.
Interventions
DEVICESphinkeeper
Intersphincteric implants in the anal sphincter
Sponsors
Region Skane
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent. 2. Subject must be at least 18 years of age 3. Subject must have a St Marks score of at least 11 4. Subject must be able to comply with study and study follow-up requirements.
Exclusion criteria
1. Subjects with Crohn's disease or Ulcerative colitis 2. Subject has (a history of) malignancy in the rectum or anal canal 3. Subject has an ongoing treatment with chemotherapy (all indications) 4. Subject has verified active anal fistula(e) 5. Subject is unable or unwilling to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of anal incontinence | 12 months | Reduction in St Marks score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative infection | 12 months | Rate of infection i.e. formation of abcess within the first year of treatment. |
| Change from baseline in pain scores on the VAS at 3 and 12 months. | Baseline, 3 months and 12 months | VAS (Visual Analog Scale) |
Countries
Sweden
Outcome results
None listed