Controlling Fecal Incontinence With a Novel Anal Device: A Randomized Clinical Trial.

Area of Science:

• Gastroenterology and Urology
• Medical Devices
• Clinical Trials

Background:

• Fecal incontinence (FI) affects 8% of adults, significantly impacting quality of life.
• Current surgical options for FI carry high risks and costs.
• Evidence for minimally invasive alternatives like anal inserts remains limited.

Purpose of the Study:

• To evaluate the efficacy of a novel single-use anal insert in reducing fecal incontinence severity.
• To compare the novel anal insert against usual care in a randomized clinical trial.

Main Methods:

• A multicenter, open-label, randomized clinical superiority trial involving 72 participants with FI.
• Participants were randomized to receive either a novel anal insert or usual care for 8 weeks.
• The primary outcome was the proportion of participants achieving a ≥3-point reduction in the St Mark's incontinence score.

Main Results:

• The primary outcome was not met: 25.7% in the insert group vs. 18.9% in the control group achieved the target score reduction.
• The anal insert group showed significant improvements in coping and depression domains of quality of life.
• The insert significantly reduced weekly fecal incontinence episodes (mean difference of -3.09 episodes) and was associated with mild, common adverse events.

Conclusions:

• The novel anal insert did not meet its primary efficacy endpoint for reducing fecal incontinence severity.
• The device demonstrated benefits in specific quality-of-life domains and a reduction in incontinence episodes.
• Findings suggest the anal insert may offer a viable minimally invasive treatment option for select FI patients.