Some patients continue to experience accidental bowel leakage despite dietary changes, pelvic floor therapy, and daily pad use. They may not be ready for—or interested in—procedural escalation, but they are looking for something more than passive containment.

This is the space often described as the “missing middle” in fecal incontinence management: the point between absorbent products and more invasive intervention, where symptom burden remains meaningful and quality of life is still affected.1

For selected patients, insert-based management may fit here. But successful use depends less on diagnosis alone and more on patient selection: symptom pattern, tolerance, cognition, caregiver support, and goals all matter.

This article outlines practical clinical indicators for identifying appropriate candidates, what to assess before recommending an insert-based option, and where StaySure™ may fit in care.

Where a Fecal Insert Device Fits in the Treatment Pathway

Device-based options are not first-line for every patient, and they are not a cure. They fit within broader conservative management of fecal incontinence, which may include:

  • Bowel habit optimization
  • Diet and fiber review
  • Medication review
  • Skin protection
  • Pelvic floor therapy or biofeedback when appropriate
  • Backup containment products
  • Selected device-based options

For some patients, those first steps improve symptoms enough. For others, leakage continues despite those efforts, and the burden remains high. That is often when clinicians begin looking for a more proactive option.

StaySure™ is a prescription-only silicone anal insert designed to help prevent accidental bowel leakage for up to 24 hours in appropriate patients. It is intended for symptom management, not treatment of underlying conditions. Clinical judgment and review of the Instructions for Use remain essential.

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Read More: The Missing Middle in FI Care: Why Conservative and Surgical Options Aren’t Enough

Clinical Signs That a Patient May Be a Reasonable Candidate

The right patient is not defined by diagnosis alone. Candidacy often becomes clearer when symptom burden and patient goals are considered together.

A patient may be a reasonable candidate if:

  • Accidental bowel leakage continues despite basic conservative steps
  • Leakage is affecting confidence, daily routine, social activity, or ability to remain at home
  • The patient wants something more proactive than absorbent products alone
  • The patient is motivated and open to using a prescription device
  • The patient or caregiver is able to participate in daily use and monitoring

The key distinction: appropriate patients are often seeking to prevent leakage, not simply manage it after it occurs.

What to Assess Before Recommending an Insert-Based Option

Before discussing a device-based approach, clinicians should look beyond the presence of leakage and assess the broader clinical context:

  • Stool pattern: consistency, frequency, predictability
  • Symptom type: urgency, seepage, passive leakage
  • Bowel status: constipation with overflow or unresolved disturbance
  • Medications: effects on stool or bowel motility
  • Mobility: bathroom access and transfer ability
  • Dexterity: ability to handle and insert the device
  • Cognition: capacity to follow instructions appropriately
  • Caregiver availability: if assistance may be needed
  • Skin status: irritation or moisture-associated damage
  • Patient goals: expectations and comfort with a device
  • Co-occurring urinary incontinence: may increase overall burden and motivation

Unresolved bowel disturbances should be addressed first when possible. Clinical reviews note that bowel disturbance is often easier to correct and less invasive to treat than sphincter-targeted therapies.2

Some patients underreport symptoms or minimize daily impact, especially in primary care, geriatrics, and home health settings.

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Which Patients May Be Less Appropriate

Some patients may not be well-suited for insert-based management:

  • Unwilling or uncomfortable with using an internal device
  • Cognitive, dexterity, or caregiver limitations that make proper use unrealistic
  • Symptoms suggesting a bowel disturbance requiring more immediate evaluation
  • Expectations that do not align with a conservative, symptom-management device

Final decisions should always be guided by the Instructions for Use, contraindications, and clinical judgment.

Patient Selection Reminder

The best candidate is not defined by diagnosis alone.
Symptom pattern, bowel status, goals, tolerance, and usability all matter.

Mini Case Vignette: When an Insert-Based Option May Make Sense

Margaret, 74, has experienced persistent accidental bowel leakage for two years despite diet changes and daily pad use. She is cognitively intact but has stopped attending her weekly bridge club and avoids car trips longer than 30 minutes.

Her daughter, who helps with caregiving, is looking for something that might reduce the daily cleanup burden. Margaret is motivated and open to trying a discreet, non-surgical option.

Her clinician discusses prescription options, including StaySure™, as one possible next step within conservative management.

Teaching point: The “right patient” is not defined by diagnosis alone, but by symptom burden, goals, usability, and fit within the broader care plan.

Questions Clinicians Can Ask to Guide Patient Selection

  • “What have you already tried for bowel leakage?”
  • “Are you mainly looking for backup protection, or hoping to prevent leakage episodes?”
  • “How is leakage affecting your daily routine or willingness to leave home?”
  • “Would you be comfortable using a prescription device if it might help?”
  • “Do you feel able to manage it on your own, or would a caregiver be helping?

These questions support shared decision-making and help set realistic expectations.

Read Next: Starting the Conversation: Helping Patients Open Up About Bowel Leakage

“The question is not simply whether a patient has fecal incontinence. It is whether they are the kind of patient who may benefit from a more proactive, prescription, device-based option.”

Closing Thoughts

The question is not simply whether a patient has fecal incontinence. It is whether they are the kind of patient who may benefit from a more proactive, prescription, device-based option, and whether that option fits their daily life, goals, and care plan.

For clinicians in primary care, geriatrics, home health, and continence care, thoughtful patient selection is the foundation of successful outcomes.

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Disclaimer

StaySure™ is a prescription-only medical device designed to help manage symptoms of accidental bowel leakage. It is not a cure for underlying conditions. Individual results may vary. Consult the Instructions for Use for complete indications, contraindications, and safety information.

References

  1. Assmann, S. L., Keszthelyi, D., Kleijnen, J., Anastasiou, F., Bradshaw, E., Brannigan, A. E., Carrington, E. V., Chiarioni, G., Ebben, L. D. A., Gladman, M. A., Maeda, Y., Melenhorst, J., Milito, G., Muris, J. W. M., Orhalmi, J., Pohl, D., Tillotson, Y., Rydningen, M., Svagzdys, S., & Vaizey, C. J. (2022). Guideline for the diagnosis and treatment of Faecal Incontinence—A UEG/ESCP/ESNM/ESPCG collaboration. United European Gastroenterology Journal, 10(3), 251–286. https://doi.org/10.1002/ueg2.12213
  2. Wald, A. (2018). Diagnosis and Management of Fecal Incontinence. Current Gastroenterology Reports, 20(3). https://doi.org/10.1007/s11894-018-0614-0