StaySure®: A New Approach to Managing Accidental Bowel Leakage
A prescription-only anal insert that helps treat fecal incontinence (FI). StaySure® offers a discreet, non-surgical alternative to absorbent products like diapers and underwear that allows you to go about your daily routine.
* Prescription required.
Product Overview
StaySure® is a soft, flexible silicone insert that forms a gentle internal seal to help manage symptoms of fecal incontinence (FI), also referred to as accidental bowel leakage (ABL).
Developed with input from gastroenterologists and people living with fecal incontinence, StaySure® offers a symptom management option that helps patients regain confidence and independence in everyday life, bridging the gap between other conservative approaches and more invasive interventions.
The device is:
- Made of 100% biocompatible silicone
- Filled with mineral oil for fluid-dynamic flexibility
- Designed for up to 24 hours of wear
- Intended for single-use with disposable applicator
Available by prescription only. Patients should discuss StaySure® with their healthcare provider to determine if it is appropriate for their needs.
Indications for Use
The Fecal Incontinence Insert is indicated for the management of Accidental Bowel Leakage (ABL) due to bowel incontinence. The rectal insert is designed for self-insertion to seal and help prevent the involuntary leakage of stool from the rectum.
Important: StaySure® is a symptom management device. It does not treat or cure the underlying causes of fecal incontinence. Please refer to the Information for Use (IFU) for complete indications, contraindications, warnings, and precautions.
How StaySure® Works
StaySure® is designed to provide a dual seal at the anorectal junction and within the anal canal. First, the bulb of the insert rests against, conforms to, and provides a seal at the anorectal junction, thus helping to prevent accidental fecal discharge from the rectum. Additionally, the shaft of the insert conforms to and fills the anal canal allowing pressure from the internal and external anal sphincters to seal the canal, thereby preventing bypass leakage.
Mechanism of Action
- Adaptive seal: The fluid-filled silicone design conforms to individual anatomy and adjusts with movement, helping maintain the seal during daily activities.
- Dual-point contact: Forms a seal within the anal canal and at the anorectal neck/junction.
- Removal options: The insert may be removed before a bowel movement or may be naturally expelled during defecation.
Insertion and Removal
The device is inserted using the included disposable plastic applicator. A soft external tab remains outside the body for security and serves as a grip for easy removal. Most users report that insertion and removal become routine after initial use. Complete instructions are provided in the patient Information for Use.
Key Benefits for Patients
StaySure® is designed to support patients in managing their symptoms and improving quality of life:
- Helps reduce accidental bowel leakage
- Supports confidence in social and daily activities
- Discreet alternative to bulky pads or absorbent briefs
- Designed to integrate into daily routines
- Up to 24 hours of wear time
- Non-surgical symptom management option
For many individuals, preventing leakage before it occurs can significantly improve quality of life compared with solutions that only absorb or contain leakage.
Device Features at a Glance
| Feature | Description |
Material | 100% silicone, mineral oil-filled |
Design | Soft, flexible; adapts via fluid dynamics |
Sealing Mechanism | Dual seal created. One within the anal canal and one at the anorectal neck/junction |
Wear Time | Up to 24 hours per insert |
Use Type | Single-use, disposable (insert and applicator) |
External Tab | Soft retainer for security and easy removal |
Biocompatibility | Latex-free, biocompatible materials |
Prescription Status | Prescription required |
Patient Selection
Who May Benefit from StaySure®
StaySure® may be appropriate for adult patients experiencing accidental bowel leakage who are seeking an alternative to absorbent products and are not candidates for or prefer to avoid surgical intervention. It can be used on its own or in conjunction with other therapies.
Candidates to Consider
- Adults with fecal incontinence affecting quality of life
- Patients dissatisfied with pads, briefs, or other absorbent products
- Patients seeking a non-surgical management option
- Patients motivated to use a device and capable of self-insertion/removal
Clinical Considerations
Prescribers should evaluate each patient individually. Review the Information for Use for contraindications, including but not limited to active inflammatory bowel disease, anorectal disease, recent anorectal surgery, or other conditions that may preclude device use.
For patients: StaySure® requires a prescription. If you are experiencing symptoms of accidental bowel leakage, please discuss management options with your healthcare provider to determine if StaySure® is appropriate for you.
Clinical Evidence & Development
StaySure® is a clinically evaluated medical device. Minnesota Medical Technologies conducted a prospective clinical study to assess the device’s performance in adults with fecal incontinence.
Clinical Study
Study Registration: ClinicalTrials.gov NCT03898778
Title: “A Study to Assess the Effects of the Minnesota Medical Technologies Anal Insert Device in Fecal Incontinence”
Study participants using StaySure® demonstrated reduced fecal incontinence episodes, improved quality of life measures, and the device was generally well tolerated. For complete study details and outcomes, refer to the published results.
Development Approach
StaySure® was developed with input from people living with fecal incontinence and in collaboration with gastroenterologists. This patient-centered approach informed the device design, comfort features, and usability.
Resources for Healthcare Professionals
Access clinical and educational materials to support prescribing and patient counseling:
Next Steps
For Healthcare Professionals
Request an evaluation kit to assess StaySure® for your practice or contact our clinical team with questions.
Request an Evaluation Kit Contact Minnesota Medical Technologies
For Patients
Visit our patient website for educational resources, frequently asked questions, and prescription ordering information. Additional education and ordering information are available at:
Visit StaySureToday.com — Patient Education & Ordering
Prescription required. Patients must have a valid prescription to order StaySure®. Discuss with your healthcare provider to determine if StaySure® is right for you.
Important Safety Information
Please review the Information for Use (IFU) for complete indications, contraindications, warnings, precautions, and instructions prior to prescribing or use. StaySure® is intended to manage symptoms of accidental bowel leakage; it does not treat or cure underlying conditions. Not all patients are appropriate candidates. Discuss potential benefits and risks with your healthcare provider.