Acceptability, effectiveness and safety of a Renew

Area of Science:

• Gastroenterology
• Surgical Innovation
• Patient Quality of Life

Background:

• Restorative proctocolectomy is a common procedure for ulcerative colitis and familial adenomatous polyposis.
• Post-surgical incontinence affects up to 25% of patients following restorative proctocolectomy.
• The Renew® insert is a novel single-use anal plug designed to address incontinence.

Purpose of the Study:

• To evaluate the acceptability, effectiveness, and safety of the Renew® insert.
• To assess the impact of the Renew® insert on nocturnal incontinence in patients post-restorative proctocolectomy.

Main Methods:

• A prospective study involving 15 patients with incontinence post-restorative proctocolectomy.
• Patients used the Renew® insert for 14 days alongside their standard care.
• Incontinence was assessed using the Incontinence Questionnaire-Bowels pre- and post-intervention.

Main Results:

• The Renew® insert was found acceptable by 53% (8/15) and effective by 40% (6/15) of patients.
• A significant reduction in nighttime seepage was observed (P=0.034).
• Only 13% (2/15) of patients reported minor safety concerns.

Conclusions:

• The Renew® insert demonstrates potential as an acceptable and effective solution for managing post-restorative proctocolectomy incontinence.
• The device offers a safe option associated with significant improvements in nighttime seepage.
• Further research with larger cohorts is warranted to confirm these findings.