StaySure® Bowel Leakage Protection Insert

No. StaySure can be purchased without a prescription. Review the Instructions for Use before first use, and contact a healthcare professional if you have questions about whether StaySure is appropriate for you.

StaySure is a single-use recto-anal insert designed for adults age 18 and older to help manage accidental bowel leakage due to fecal incontinence.

The manufacturer recommends starting with Standard (10 mm) unless your physician or nurse advises otherwise. If leakage or unexpected expulsion occurs during daily activity, ask your clinician whether Large (13 mm) may be appropriate.

One insert may be worn continuously for up to 24 hours or until the next bowel movement. Only one insert should be used at a time. After it is expelled or removed, replace it with a new insert if needed.

No. Each insert and applicator is single-use and should be discarded with normal trash. Do not flush either item.

Do not use StaySure for pediatric patients; with a recent anal fissure; Grade III–IV internal hemorrhoids or thrombosed external hemorrhoids; recent anal or rectal pain or bleeding; recent fecal impaction with overflow diarrhea; an ileo-anal pouch; or a known silicone allergy. Do not use it with suppositories. Review the full Instructions for Use and ask your clinician if you are unsure.

In a prospective 4-week treatment study of 59 participants, weekly fecal incontinence episodes declined by 69%. A reduction of at least 50% was achieved by 76.3% of participants, and 54.2% achieved a reduction of at least 75%. No treatment-related serious adverse events were reported.

The study was uncontrolled, 93% of participants were women, and follow-up was limited to four weeks. The authors called for longer-term research. Minnesota Medical Technologies funded the study, and relevant inventor and institutional financial interests were disclosed.