Retaking bowel control in fecal incontinence using a novel anal device

Fecal incontinence (FI) is defined as the complaint of involuntary loss of liquid and/or solid stool. FI is a highly prevalent condition, occurring in 7.7% (range 2.2 to 24%) in community dwelling women. In nursing home patients, prevalence is even higher (up to 50%). In addition, epidemiological studies suggest that up to 70% of patients with FI have not reported their symptoms to healthcare professionals. Thus, the prevalence of FI is probably underestimated. Based on these figures, at least 1.3 million persons in the Netherlands are potentially affected. The negative consequences of FI include not only the physical debilitation, but also the social isolation, embarrassment, loss of dignity, as well as the effect on intimate relationships and self-esteem. In addition, FI is associated with considerable costs. Healthcare costs are estimated 55% higher in people with FI than those without. With a continuously aging population, the societal impact of FI is expected to increase further. The goal of treatment in FI is to restore continence and improving quality of life. Management of FI consists of conservative and surgical approaches. Unfortunately, no single option has been shown to provide consistent, long-term effectiveness with low complication rates, making FI difficult to manage. However, symptoms may be alleviated by fairly simple measures. For instance, anal plugs are designed to temporarily occlude the anal canal to prevent stool leakage. However, a considerable drawback is poor tolerability – past studies demonstrated a considerably high dropout rate. The most common complaint with anal plug use is discomfort and failure to retain the device. If tolerated, the device may be helpful to alleviate symptoms particularly in patients with impaired anal-rectal sensation and those who are institutionalized or immobilized. However, the impact of anal plugs on quality of life or cost-effectiveness have not been documented. Recently, a novel anal insert device has become available on the EU market which has specifically been designed to increase tolerability. This is achieved by the fact that the device is filled with liquid mineral oil which makes it possible for the device to adjust to the contours of the individual anatomy, conforming and moving with the body to prevent leakage and allow users to remain active and involved. In this project, a project team will be assembled and plans were be made for submitting a project idea in the 3rd open round GGH. Specific task include: small pilot study with use of the novel device in patients; cognitive interviews with FI patients; literature review; project group meeting with different stakeholders. The timeline is from March-July 2019.