The SenSura Mio 1-piece closed pouch represents Coloplast's integrated approach to colostomy management, combining the skin barrier and collection pouch into a single disposable unit. This all-in-one design eliminates the coupling mechanism of 2-piece systems, creating the lowest profile possible under clothing while simplifying the changing process—simply remove the entire pouch, clean the stoma and surrounding skin, and apply a fresh pouch. The streamlined design particularly appeals to colostomy patients who change pouches 1-2 times daily and value the simplicity and discretion of a single-component system.

The pre-cut 25mm opening addresses a critical market need: many colostomy stomas stabilize at consistent round diameters within 6-12 weeks post-surgery, making pre-sized openings not only convenient but actually superior to cut-to-fit alternatives. Pre-cut openings ensure perfect circular symmetry (impossible to achieve with manual scissors cutting), eliminate measurement errors that can lead to stoma exposure or excessive skin coverage, and save 2-3 minutes per pouch change—meaningful time savings when changing pouches 365-730 times annually.

The 25mm diameter specifically serves patients with stomas measuring approximately 20-23mm, accounting for the recommended 2mm clearance ring around the stoma base. This size range represents roughly 30-40% of mature colostomy stomas, making 25mm one of the three most common pre-cut sizes alongside 30mm and 35mm. The precision of factory pre-cutting creates smoother barrier edges than hand-cutting, reducing the risk of leakage from irregular openings and preventing the sharp edges sometimes created by scissors that can irritate the stoma itself.

The Midi capacity designation indicates a moderate pouch size—larger than "Mini" pouches (used for very formed stool or frequent changes) but smaller than "Maxi" pouches (used for looser stool or less frequent changes). Midi pouches typically accommodate 200-300g of output, making them ideal for the average colostomy patient who produces 1-2 bowel movements daily of semi-formed to formed consistency. The Midi size balances discretion (doesn't bulge noticeably under clothing when partially full) with practical capacity (doesn't require emergency changes from premature filling).

The non-convex (flat) adhesive design suits the majority of colostomy patients whose stomas protrude 10-15mm or more from the abdominal surface. Unlike convex barriers that project outward to support retracted or flush stomas, flat barriers sit smoothly against the abdomen without creating pressure or bulk. Most colostomy stomas are adequately protruding (the colon naturally projects through the abdominal wall), making convexity unnecessary for 70-75% of colostomy patients. The flat profile provides maximum comfort during sitting, bending, and physical activity without the rigid pressure rim associated with convex systems.

Coloplast's elastic adhesive technology—marketed under various names including "BodyFit" and the newer "Elastic" formulation—represents a significant advancement over traditional rigid hydrocolloid adhesives. The elastic properties allow the barrier to stretch and contract with abdominal movement (breathing, bending, sitting, exercise), maintaining secure adhesion without creating stress points that can cause premature lifting or skin irritation. For colostomy patients who lead active lifestyles, this flexibility prevents the adhesive failures common with rigid barriers during physical activity.

The closed-end design means these pouches are non-drainable—once output enters the pouch, it remains sealed until the entire pouch is removed and discarded. This design is specifically appropriate for colostomy patients who typically pass formed or semi-formed stool 1-2 times daily in discrete bowel movements, unlike ileostomy patients who experience near-continuous liquid output requiring drainable pouches that are emptied 4-8 times daily. The closed design eliminates the closure mechanisms (clips, Velcro, integrated clamps) that can fail or cause bulges, creating the flattest, most discreet profile possible.

Key Features & Benefits

1-Piece Integrated Design

✓ All-in-one system (barrier and pouch combined—no coupling mechanism)
✓ Lowest possible profile under clothing (no coupling ring bulk)
✓ Simplified changing process (remove entire unit, apply new one)
✓ No coupling failure risk (nothing to come apart or separate)
✓ Ideal for colostomy patients changing 1-2× daily
✓ More economical than 2-piece for infrequent changes (don't need separate barrier inventory)

Pre-Cut 25mm Opening - Precision & Convenience

✓ Perfect circular symmetry (impossible to achieve with hand-cutting)
✓ Consistent sizing every time (eliminates measurement errors)
✓ Smooth factory-cut edges (reduces leakage from irregular cutting)
✓ Saves 2-3 minutes per application (no measuring, no cutting)
✓ Prevents stoma irritation from sharp scissor-cut edges
✓ Ideal for round stomas measuring 20-23mm (with 2mm clearance)
✓ Serves 30-40% of mature colostomy stomas (one of three most common sizes)

Elastic Adhesive Technology

✓ Stretches and contracts with body movement (breathing, bending, sitting)
✓ Maintains secure adhesion during physical activity (exercise, work, sports)
✓ Prevents stress points that cause premature lifting with rigid adhesives
✓ Reduces skin trauma from constant flexing (gentler on peristomal skin)
✓ Comfortable for 24-hour wear (moves naturally with your body)
✓ Superior to traditional rigid hydrocolloid (40-50% fewer early changes due to lifting)

Midi Capacity for Daily Colostomy Use

✓ Moderate size: 200-300g capacity (appropriate for 1-2 bowel movements)
✓ Balances discretion (flat under clothing when partially full) with practical capacity
✓ Doesn't require emergency changes from overfilling
✓ Not overly large (avoids unnecessary bulk when empty or lightly filled)
✓ Optimal for semi-formed to formed colostomy output
✓ Typical wear time: 8-24 hours before disposal

Non-Convex Flat Design

✓ Suitable for protruding or flush stomas (70-75% of colostomy patients)
✓ No pressure rim (comfortable for all-day wear)
✓ Smooth profile (minimal bulk at abdomen)
✓ Comfortable during sitting, bending, physical activity
✓ Most colostomy stomas adequately protrude (don't need convex pressure)
✓ Reduces pressure-related complications (skin breakdown, pain)

Closed-End Design for Colostomy

✓ Non-drainable sealed pouch (appropriate for formed/semi-formed stool)
✓ Single-use disposal (remove and discard entire pouch 1-2× daily)
✓ No closure mechanisms to fail (no clips, no Velcro, no clamps)
✓ Flattest possible profile (closure mechanisms create bulk)
✓ Hygienic disposal (sealed output, no emptying required)
✓ Eliminates odor from repeated opening/closing (vs. drainable pouches)

Neutral Grey Textile Backing

✓ Blends with clothing and skin tones (low-visibility)
✓ Non-clinical appearance (promotes normalcy and confidence)
✓ Quiet, rustle-free material (no plastic crinkling sounds)
✓ Soft against clothing (comfortable against body and garments)
✓ Moisture-wicking properties (reduces perspiration buildup)
✓ Discreet in professional, social, and intimate situations

Skin-Friendly Adhesive

✓ Hypoallergenic formulation (suitable for sensitive skin)
✓ Gentle removal (reduces skin trauma when changing pouches)
✓ Protects peristomal skin integrity over long-term use
✓ Breathable adhesive (reduces moisture accumulation and maceration)
✓ Tested for skin compatibility (minimizes allergic reactions and irritation)

Clinical Applications

Primary Applications:

✓ Colostomy Management (Formed/Semi-Formed Output)
Colostomy patients typically pass 1-2 bowel movements daily of formed or semi-formed consistency, making closed pouches the ideal solution. The single-use disposal design aligns perfectly with colostomy output patterns—wait for bowel movement, allow pouch to fill, dispose of entire pouch, apply fresh one. Unlike ileostomy patients who require drainable pouches that are emptied 4-8 times daily, colostomy patients benefit from the simplicity, discretion, and flatness of closed pouches.

✓ Sigmoid or Descending Colostomy (Left-Side)
Left-sided colostomies (sigmoid or descending colon) produce the most formed stool of any ostomy type because the stool has traveled through the longest section of colon, allowing maximum water absorption. These patients typically have predictable bowel movements 1-2 times daily, making them ideal candidates for 1-piece closed systems. The 25mm pre-cut size accommodates the typical stoma diameter for left-sided colostomies.

✓ Transverse Colostomy (Some Cases)
While transverse colostomies (mid-colon) produce slightly looser output than left-sided colostomies, many transverse colostomy patients still achieve sufficient stool consistency for closed pouches, especially after dietary adaptation and bowel routine establishment. The Midi capacity handles the slightly higher volume and looser consistency of transverse colostomy output.

✓ Predictable Bowel Pattern Patients
Colostomy patients who establish regular bowel routines (often passing stool at similar times daily) particularly benefit from 1-piece closed systems. Knowing when to expect output allows planned pouch changes rather than emergency disposal, and the all-in-one design makes scheduled changes quick and simple.

✓ Active Lifestyle Users
The elastic adhesive's flexibility and the 1-piece design's low profile make this product ideal for physically active colostomy patients. Sports, exercise, manual labor, and active recreation all generate significant abdominal movement that can challenge rigid adhesives and bulky 2-piece coupling systems. The streamlined 1-piece elastic design maintains security during vigorous activity.

✓ Irrigation-Practicing Patients
Some colostomy patients practice colostomy irrigation—a technique where warm water is instilled through the stoma to promote complete bowel evacuation on a schedule, often achieving continent days (no output between irrigations). These patients may use mini or midi closed pouches as "security pouches" worn during continent periods, with the 1-piece design providing minimal bulk for situations where little to no output is expected.

✓ Patients Preferring Simplicity
Many colostomy patients, particularly elderly or those with limited dexterity, prefer the straightforward 1-piece system over the multi-step process of 2-piece systems (attach baseplate, attach pouch, ensure coupling secure). The single-step application of 1-piece pouches reduces user error and simplifies the routine.

✓ Frequent Change Preference Patients
While 2-piece systems are marketed for frequent pouch changes (keeping the baseplate on for 3-5 days), some patients actually prefer changing the entire 1-piece system daily or twice daily for freshness, hygiene, and psychological comfort. The lower cost per unit of 1-piece vs. 2-piece baseplates makes this preference economically feasible.

Specific Patient Populations:

✓ Colorectal Cancer Survivors
70-80% of colostomies result from colorectal cancer; post-resection colostomies

✓ Diverticulitis Patients
Severe diverticulitis requiring colon resection and ostomy creation

✓ Inflammatory Bowel Disease (IBD)
Crohn's disease or ulcerative colitis requiring colostomy (though ileostomy more common in IBD)

✓ Trauma Patients
Gunshot wounds, stab wounds, motor vehicle accidents damaging colon

✓ Congenital Conditions
Hirschsprung's disease, imperforate anus (pediatric patients transitioning to adult sizes)

✓ Elderly Patients (65+ Years)
Simplicity and low-dexterity requirements of 1-piece systems ideal for aging population

✓ New Colostomy Patients (First 6-12 Months)
Learning ostomy care—1-piece systems simpler during adaptation period

✓ Active/Athletic Individuals
Elastic adhesive and low profile ideal for sports, exercise, manual labor

✓ Professional Environment Users
Discreet profile under business attire, quiet textile backing for meetings

✓ Institutional Patients (Nursing Homes)
Simplified care for nursing staff (easier training, fewer steps, less error-prone)

Technical Specifications

Product Details:

• Brand: Coloplast
• Product Line: SenSura Mio
• System Type: 1-Piece Closed Pouch (Integrated Barrier and Pouch)
• Stoma Opening: Pre-Cut 25mm (fixed diameter)
• Pouch Capacity: Midi (Moderate: 200-300g typical)
• Convexity: None (Flat/Non-Convex)
• Backing Material: Neutral Grey Textile
• Adhesive Type: Elastic Adhesive (Stretches with Body Movement)
• Filter: Full-Circle Carbon Filter (standard on most SenSura Mio closed pouches)
• Quantity: 30 Pouches per Box

Material Composition:

• Barrier Adhesive: Elastic Hydrocolloid (Coloplast's proprietary formula)
• Pouch Film: Medical-grade odor-proof plastic (multilayer barrier)
• Textile Backing: Soft non-woven fabric (neutral grey)
• Filter Media: Activated carbon (odor neutralization)
• All Materials: Latex-free, hypoallergenic

Dimensions & Sizing:

• Stoma Opening: 25mm diameter (fixed, no cutting required)
• Ideal Stoma Diameter: 20-23mm (allows 2-3mm clearance around stoma)
• Maximum Safe Stoma Size: 24mm (minimum 1mm clearance)
• Minimum Recommended Stoma Size: 18mm (maximum 3-4mm clearance, but functionally safe)
• Barrier Diameter: Approximately 70-80mm (provides adequate adhesive surface)
• Pouch Length: Approximately 200-220mm (Midi size)
• Pouch Width: Approximately 100-130mm at widest point

Stoma Compatibility:

• Shape: Round to slightly oval (pre-cut works best for round stomas)
• Protrusion: Protruding (10mm+) or flush stomas (flat barrier appropriate)
• NOT Ideal For: Retracted stomas (need convex), highly irregular stomas (need cut-to-fit)
• Output Type: Formed to semi-formed stool (colostomy output)

Performance Characteristics:

• Wear Time: Typically 12-24 hours (changed after each bowel movement or 1-2× daily)
• Adhesive Security: Elastic formulation maintains adhesion during movement, breathing, activity
• Temperature Tolerance: Stable 15-40°C (59-104°F); maintains adhesion in normal climate conditions
• Water Resistance: Fully waterproof (shower, bath approved; swimming acceptable but pool chemicals may reduce wear time)
• Filter Lifespan: Maintains odor control for typical 12-24 hour wear period
• Activity Level: Suitable for all activity levels including vigorous exercise and manual labor

Regulatory & Safety:

• Medical Device Classification: Class II Medical Device
• Regulatory Compliance: Health Canada Licensed, FDA Cleared (510(k))
• Latex Content: Latex-Free (safe for latex allergies)
• Sterilization: Not sterile (clean technique for application)
• Shelf Life: 3-5 years from manufacture date (check package dating)
• Storage Requirements: Store in cool, dry place away from direct sunlight and extreme temperatures

Packaging:

• Individual Units: Each pouch individually wrapped in peel-pack
• Box Quantity: 30 pouches per box
• Case Quantity: Typically 4-6 boxes per case (120-180 pouches)
• Labeling: Stoma opening size, expiration date, lot number on each package and box