NCT03080753

Treatment of Anal Incontinence With Intersphincteric Implants

Treatment of Anal Incontinence Using Intersphincteric Implants (SphinKeeper)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anal Incontinence
• Fecal Incontinence

Interventions

Type	Name	Description
DEVICE	Sphinkeeper	Intersphincteric implants in the anal sphincter

Timeline

• Start date: 2017-10-11
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2017-03-15
• Last updated: 2024-03-01

Locations

1 site across 1 country: Sweden