For clinicians, managing fecal incontinence (FI) and accidental bowel leakage (ABL) can be one of the more challenging aspects of outpatient and long-term care. While many patients experience meaningful improvement with first-line strategies like diet modification, pelvic floor muscle training, and absorbent products, others plateau, stuck between “something has to change” and “nothing appropriate remains short of surgery.”

That clinical gap has real consequences: reduced quality of life, skin complications, avoidance of social engagement, and increased caregiver burden. Addressing FI requires not just awareness, but a practical continuum of care that reflects patients’ real–world needs.

One newer option in that continuum is StaySure™, a non-surgical device designed for everyday use that can help fill the conservative-to-invasive care gap in FI management. Below, we unpack where StaySure™ fits clinically, practically, and economically for the patients you see every day.

Understanding the Traditional FI Care Pathway

Fecal incontinence is multifactorial, caused by sphincter dysfunction, reduced rectal sensation, diarrhea, neurological disorders, or post-surgical changes, and often requires a personalized approach.1 Standard management pathways typically begin with conservative strategies, guided by clinical assessment.

Typical conservative care for fecal incontinence includes:2

  • Dietary changes and fiber supplementation
  • Stool-modifying medications
  • Pelvic floor muscle training and biofeedback
  • Behavioral bowel training
  • Absorbent products and toileting aids

Despite aggressive use of these interventions, patients frequently report ongoing leakage or lack of confidence in daily activities.3

When these first-line therapies are insufficient and the patient’s symptoms remain disruptive, clinicians often consider escalation to more invasive approaches such as anal sphincter repair, sacral nerve stimulation, or even colostomy, all of which carry higher risk, cost, and recovery burden.

This leaves many patients, and clinicians, asking the same question: Is there a sensible next step between pads and surgery?

Introducing StaySure™: A Practical Next Step

StaySure™ is a flexible, soft silicone rectal insert designed to prevent accidental bowel leakage, not just contain it. Unlike products that absorb leakage after it occurs, StaySure™ creates a gentle internal seal at the anorectal junction, helping patients avoid leakage before it starts.

In July 2025, StaySure™ received 510(k) clearance from the U.S. Food and Drug Administration (FDA), which allows clinicians to offer it as a non-surgical option for managing FI and ABL in patients with persistent symptoms.

Clinically, StaySure™ is positioned within the conservative care spectrum, a device-based option that sits between behavioral modifications and invasive procedures. It provides a real, patient-managed solution for those who need something stronger than absorbents but aren’t candidates for or don’t want surgery.

Learn More About the StaySure™ Device

Key Clinical Advantages of StaySure™

 

1. Prevention Rather Than Containment

Traditional absorbent products catch leakage after it happens. StaySure™ is designed to prevent leakage at the source by forming an internal seal, offering a proactive layer of protection.

This distinction matters: prevention can reduce odor, skin irritation, and the psychological stress of unplanned leakage, all of which are significant drivers of patient anxiety and quality-of-life impact.

2. Non-Surgical, Patient-Managed Care

StaySure™ requires no anesthesia, surgical implantation, or extended recovery. It can be inserted and removed independently by patients or with caregiver assistance, making it appropriate for:

  • Individuals with mild to moderate FI
  • Patients who have plateaued with first-line therapies
  • Care settings where surgical referral is not practical
  • Patients prioritizing independence and comfort

This fills a real clinical gap where neither conservative strategies nor surgical escalation are ideal.

3. Evidence and Real-World Use

StaySure™ has been available in Europe, marketed as the Navina Insert, since 2021 and has shown clinical effectiveness in reducing leakage frequency and improving quality of life in real-world use.2 Recent clinical trial data (including a Mayo Clinic completed study) demonstrated reduced FI episodes and improved patient confidence, with full publication expected soon.

This growing evidence base gives clinicians a foundation for offering StaySure™ with confidence.

4. Improved Patient Quality of Life

FI profoundly affects daily life: patients plan outings around bathrooms, restrict travel, and avoid social interactions. Prevention of leakage, rather than reaction to it, helps restore autonomy and reduces:4

  • Embarrassment and fear of social exposure
  • Excessive use of absorbents
  • Skin irritation and dermatitis
  • Caregiver burden

These improvements align with holistic care goals in geriatrics, GI, colorectal, primary care, and home health settings.

Practical Implementation in Clinical Practice

Here’s how StaySure™ fits into your FI management framework:

Start with a solid assessment:

Include bowel history, stool consistency evaluation, and pelvic floor function assessment. Ensure bowel-related medications, supplements, and comorbidities (e.g., diarrhea, IBS) are reviewed.

Initiate first-line conservative care:

Dietary fiber, antidiarrheal agents, pelvic floor training, and absorbent aids remain valuable.

Introduce StaySure™ when:

  • Symptoms persist despite consistent conservative management
  • Patients remain bothered by leakage affecting quality of life
  • Surgery is not indicated or desired
  • Patients seek a discreet, daily approach to leakage prevention

Frequently Asked Questions (FAQ)


Is StaySure™ considered conservative or intermediate treatment?

StaySure™ is a non-surgical, device-based option that expands conservative care without requiring surgical intervention.

Is it appropriate before trying surgical options?

Yes. It can be offered as a next step for patients who remain symptomatic after standard conservative therapies.

How long can it be worn?

StaySure™ is designed for up to 24-hour wear per device.

Can patients insert and remove it themselves?

Yes; it is designed for patient management, though some may require caregiver assistance.

Does it replace pelvic floor therapy?

No. It complements other conservative treatments and is part of a comprehensive care plan.

What evidence supports its use?

The device has been cleared by the FDA based on safety and performance data, has been available in Europe since 2021, and has demonstrated reduced FI frequency and improved quality of life in clinical evaluations.

Conclusion

Many patients with fecal incontinence find themselves in a treatment limbo: beyond first-line therapies, but not ready for surgical options. StaySure™ meets that need as a non-surgical, patient-managed, preventive device that bridges the gap between conservative strategies and invasive interventions.

Incorporating StaySure™ into clinical practice offers a practical, evidence-informed option that supports dignity, independence, and improved quality of life. As clinicians, expanding your toolkit with intermediate solutions like StaySure™ helps ensure that care truly meets patients where they are, not where we hope they should be.

Download StaySure Clinician Brochure

References

  1. Shah, R., & Villanueva Herrero, J. A. (2021). Fecal Incontinence. PubMed; StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK459128/
  2. National Institutes of Health. (2017). Treatment of Fecal Incontinence | NIDDK. National Institute of Diabetes and Digestive and Kidney Diseases. https://www.niddk.nih.gov/health-information/digestive-diseases/bowel-control-problems-fecal-incontinence/treatment
  3. Saldana Ruiz, N., & Kaiser, A. M. (2017). Fecal incontinence - Challenges and solutions. World Journal of Gastroenterology, 23(1), 11–24. https://doi.org/10.3748/wjg.v23.i1.11
  4. Meyer, I., & Richter, H. E. (2015). Impact of Fecal Incontinence and Its Treatment on Quality of Life in Women. Women’s Health, 11(2), 225–238. https://doi.org/10.2217/whe.14.66