Treatment of Anal Incontinence With Intersphincteric Implants

Launched by REGION SKANE · Mar 14, 2017

Keywords

ClinConnect Summary

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 substantia...

Gender

ALL

Eligibility criteria

• 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.