The SenSura Mio 2-piece Flex closed pouch represents Coloplast's versatile approach to colostomy management, combining the flexibility advantages of 2-piece systems with the hygiene and simplicity benefits of closed-end pouches. This configuration serves the specific needs of colostomy patients who produce formed or semi-formed stool 1-2 times daily but prefer the 2-piece system's ability to remove and replace pouches without disturbing the skin barrier—whether for stoma inspection, cleaning, pouch capacity changes, or personal preference.

The 35mm flange size specifically accommodates SenSura Mio Flex baseplates with 35mm coupling rings, typically paired with stoma openings ranging from 25-33mm (accounting for the 2-3mm clearance recommended around the stoma base). The 35mm flange represents the larger end of the common flange size spectrum—smaller than specialty large-stoma sizes (50mm, 60mm, 70mm) but significantly larger than the most common sizes (40mm, 50mm)—serving approximately 15-20% of the ostomy population who have larger mature stomas or who started with smaller flanges and progressed to larger sizes as their stomas stabilized post-operatively.

The Flex coupling system utilizes a soft adhesive ring rather than the rigid mechanical Click system, allowing the pouch to bend, flex, and move naturally with abdominal contours during all physical activities—sitting, standing, bending, twisting, breathing. This flexibility creates a comfort advantage for users with active lifestyles, reduces pressure points on peristomal skin, and operates silently (no audible "click" sound during attachment or repositioning), making it ideal for users who value discretion in professional, social, or intimate settings.

The Maxi capacity designation indicates this pouch holds significantly more than standard (Midi) or minimal (Mini) sizes, typically accommodating 400-500g of output before requiring disposal. For colostomy patients, this extended capacity translates to longer wear times between changes—often 24-36 hours even with 2 bowel movements—and reduces the risk of emergency changes from premature filling. The Maxi size particularly benefits users with looser colostomy output (transverse colostomies, recent dietary changes, temporary bowel acceleration from illness or medication), those who prefer changing pouches only once daily for convenience, and users who want security during long work shifts, travel, or overnight activities without mid-period disposal needs.

The closed-end design—non-drainable, sealed at the bottom—is specifically engineered for colostomy output patterns. Unlike ileostomy or urostomy patients who experience near-continuous liquid output requiring drainable pouches that are emptied 4-8 times daily, colostomy patients typically pass discrete bowel movements of formed or semi-formed stool 1-2 times daily, making single-use disposal both hygienic and practical. The absence of drainage mechanisms (clips, integrated closures, or taps) creates the flattest possible pouch profile under clothing and eliminates the most common failure points in drainable systems—closure mechanism leaks.

The 2-piece system design separates the skin barrier (baseplate) from the collection pouch, allowing users to change pouches multiple times while keeping the baseplate adhered to skin for 3-5 days. This approach offers several strategic advantages: the ability to inspect the stoma and peristomal skin by temporarily removing the pouch, flexibility to switch between pouch types on the same baseplate (closed to drainable, midi to maxi, opaque to transparent), reduced adhesive contact with skin (fewer barrier changes = less skin trauma), and cost efficiency when changing pouches more than twice daily (reusable barrier spreads cost over 3-5 days rather than purchasing integrated 1-piece systems for each change).

The neutral grey textile backing represents Coloplast's design philosophy emphasizing discretion and normalization—the non-clinical appearance and quiet, rustle-free material allows ostomy patients to wear form-fitting clothing, participate in professional environments, and engage in intimate situations without the visual or auditory cues that announce medical equipment. The soft textile feels comfortable against skin and clothing, wicks moisture away from the body surface, and resists the shiny plastic appearance that can be visible through thin fabrics.

Key Features & Benefits

2-Piece Flex Coupling System (35mm)

✓ Soft adhesive ring attachment (not mechanical—bends and flexes with body)
✓ Silent operation (no clicking sounds during attachment or movement)
✓ Comfortable for all-day wear (no rigid pressure points on abdomen)
✓ Easy attachment and removal (press together, peel apart—simple technique)
✓ 35mm flange accommodates larger stomas (typically 25-33mm diameter with clearance)
✓ Serves 15-20% of ostomy population (less common than 40-50mm, but significant segment)
✓ Compatible ONLY with SenSura Mio Flex 35mm baseplates (not Click, not other sizes)

2-Piece System Advantages

✓ Change pouches without removing baseplate (baseplate stays 3-5 days, change pouches 1-3× daily)
✓ Inspect stoma easily (remove pouch temporarily, examine stoma/skin, reattach same or fresh pouch)
✓ Switch pouch types on same baseplate (closed to drainable, midi to maxi as needed)
✓ Reduce skin trauma (fewer adhesive removals = less stripping of skin cells)
✓ Cost-effective for frequent changes (if changing 3+ times daily, reusable baseplate spreads cost)
✓ Flexibility for lifestyle changes (different pouches for work vs. home vs. sports)

Closed-End Design for Colostomy

✓ Non-drainable sealed pouch (appropriate for formed/semi-formed colostomy output)
✓ Single-use disposal (remove and discard entire pouch after filling)
✓ No closure mechanisms (no clips, Velcro, or clamps to fail or create bulk)
✓ Flattest possible profile (closure mechanisms add 3-5mm thickness—closed pouches eliminate this)
✓ Hygienic disposal (sealed output, no need to empty into toilet if preferred)
✓ Eliminates closure-related leaks (most common drainable pouch failure = closure malfunction)
✓ Ideal for formed stool (colostomy typically produces 1-2 discrete bowel movements daily)

Maxi Capacity for Extended Wear

✓ 400-500g capacity (2-3× larger than Mini, 50-75% larger than Midi)
✓ Longer wear times (24-36 hours typical, even with 2 bowel movements)
✓ Reduces emergency changes (premature filling less likely with extra capacity)
✓ Overnight security (contains full evening bowel movement plus morning movement)
✓ Long work shifts (10-12 hour days without mid-shift disposal)
✓ Travel convenience (airport security, long flights, road trips with infrequent rest stops)
✓ Still discreet when partially full (elastic textile backing doesn't bulge noticeably until 75%+ full)

Flexible Textile Construction

✓ Elastic pouch material (stretches and contracts with abdominal movement)
✓ Soft neutral-grey textile backing (blends with clothing and skin tones)
✓ Quiet, rustle-free fabric (no plastic crinkling sounds during movement)
✓ Non-clinical appearance (promotes normalcy and confidence)
✓ Moisture-wicking properties (reduces perspiration buildup between pouch and skin)
✓ Comfortable against clothing (soft fabric feel, not plastic)

Compatibility & System Integration

✓ Must use SenSura Mio Flex 35mm baseplates (flange size and coupling type must match)
✓ NOT compatible with: Click coupling (mechanical), other flange sizes (40mm, 50mm, 60mm, 70mm), other brands
✓ CAN switch to: Other SenSura Mio Flex 35mm pouches (drainable, different capacities, transparent)
✓ System flexibility: Build complete system with matching baseplate, various pouch options

Filter Technology

✓ Full-circle activated carbon filter (most SenSura Mio closed pouches include)
✓ Odor control (neutralizes gas odor before release from pouch)
✓ Prevents ballooning (allows gas to escape, pouch remains flat)
✓ Filter lifespan: Typically effective 18-36 hours (matches closed pouch wear time)
✓ Moisture-resistant filter design (doesn't saturate as quickly as older filter technology)

Clinical Applications

Primary Applications:

✓ Descending or Sigmoid Colostomy (Left-Side) - Primary Market
Left-sided colostomies produce the most formed stool of any ostomy type because output has traveled through the longest section of colon, allowing maximum water absorption. These patients typically have 1-2 predictable bowel movements daily, making closed pouches ideal. The 2-piece system allows easy pouch changing after each bowel movement without disturbing the baseplate. The 35mm flange size accommodates the mature stomas common with left-sided colostomies, which tend to be slightly larger than transverse colostomy stomas.

✓ Transverse Colostomy with Formed Output
While transverse colostomies (mid-colon) generally produce looser output than left-sided colostomies, many transverse colostomy patients achieve sufficient stool consistency for closed pouches after dietary adaptation and establishment of bowel routines. The Maxi capacity specifically accommodates the slightly higher volume and looser consistency of transverse output. The 2-piece system allows switching to drainable pouches on the same baseplate if output becomes temporarily looser (illness, dietary changes, medications).

✓ Colostomy Patients Preferring 2-Piece Systems
While 1-piece closed systems are more common for colostomy, certain patients specifically prefer 2-piece configurations: those wanting easy stoma inspection without full barrier removal, users switching between pouch types frequently (closed for typical days, drainable for loose-output days), patients with sensitive skin benefiting from fewer barrier changes, and individuals who previously used 2-piece systems and prefer familiar routines.

✓ Larger Mature Stomas (25-33mm)
The 35mm flange specifically serves patients whose stomas have stabilized at the larger end of the common diameter range. Stoma size is influenced by surgical technique, body habitus, colon caliber, and healing patterns. Patients with larger stomas often started with 40mm or 45mm flanges immediately post-op (accommodating surgical swelling) and transitioned to 35mm as edema resolved and stoma size stabilized by 6-12 weeks post-surgery.

✓ Active Lifestyle Users Wanting Extended Capacity
The combination of Flex coupling comfort and Maxi capacity makes this product ideal for physically active colostomy patients. Athletes, manual laborers, hikers, and active retirees benefit from the flexibility during movement (Flex coupling advantage) and extended wear time (Maxi capacity advantage). The ability to complete long workouts, work shifts, or outdoor activities without mid-activity pouch changes provides significant quality-of-life benefits.

✓ Overnight Wear Preference Patients
Many colostomy patients have evening bowel movements (after dinner, before bed) and prefer wearing a fresh pouch overnight. The Maxi capacity ensures the pouch can contain a full evening bowel movement plus potential morning bowel movement without requiring a middle-of-the-night change. The 2-piece system allows a quick evening pouch change (leaving baseplate in place) for overnight freshness.

✓ Professional Environment Users
Users in professional settings (business, education, healthcare, customer-facing roles) value the discretion of closed pouches (no need to empty in workplace restrooms) and the extended capacity of Maxi sizing (reducing mid-day changes). The neutral grey textile and quiet fabric backing maintain professionalism under business attire. The 2-piece system allows a morning baseplate application that lasts the entire workweek, with simple pouch changes each morning before work.

✓ Travel-Frequent Patients
Business travelers, vacation enthusiasts, and transportation professionals benefit from Maxi capacity reducing change frequency during transit. Airport security, long flights, road trips, and cruise vacations all present ostomy management challenges—extended capacity minimizes public restroom dependence and reduces carried supplies. The 2-piece system allows strategic pouch changes (fresh pouch before flight, before long drive) while maintaining the same baseplate for the entire trip duration.

Specific Patient Populations:

✓ Colorectal Cancer Survivors (70-80% of Colostomies)
Post-resection colostomies following colon cancer; 35mm flange common for larger tumors requiring wider surgical margins

✓ Diverticulitis with Perforation
Emergency colostomies for perforated diverticula; often progress to 35mm as post-op edema resolves

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

✓ Trauma Patients with Colon Injury
Gunshot wounds, stab wounds, motor vehicle accidents; larger stomas sometimes created in emergency surgeries

✓ Elderly Colostomy Patients (65+ Years)
Simplicity of closed pouches + 2-piece stoma inspection benefits ideal for aging population

✓ Active Adults (30-60 Years)
Working professionals, parents, athletes—need discretion, extended capacity, and system flexibility

✓ Patients with Colostomy Prolapse
Stoma protrusion increased; larger flange sizes (35mm) accommodate prolapsed circumference

✓ Bariatric Colostomy Patients
Higher BMI associated with larger stomas; 35mm flange common in this population

✓ Patients Transitioning from Larger Flanges
Started at 40-50mm post-op, downsized to 35mm as stoma edema resolved

Technical Specifications

Product Details:

• Brand: Coloplast
• Product Line: SenSura Mio Flex
• System Type: 2-Piece Closed Pouch
• Coupling Type: Flex (Soft Adhesive Ring)
• Flange Size: 35mm (Red Color-Coding)
• Pouch Capacity: Maxi (High-Volume: 400-500g typical)
• End Design: Closed (Non-Drainable, Sealed Bottom)
• Backing Material: Neutral Grey Textile
• Filter: Full-Circle Activated Carbon Filter (Standard)
• Quantity: 30 Pouches per Box

Material Composition:

• Coupling Ring: Flexible adhesive (hypoallergenic, latex-free)
• 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, skin-compatible

Dimensions & Capacity:

• Coupling Diameter: 35mm (Red color-coding matches red baseplate ring)
• Pouch Length: Approximately 260-280mm (Maxi size)
• Pouch Width: Approximately 130-160mm at widest point
• Maxi Capacity: 400-500g typical (specific volume varies by fill consistency)
• Profile When Empty: Approximately 2-3mm thickness (very flat under clothing)
• Profile When Full: Approximately 15-25mm thickness (still relatively discreet)

Baseplate Compatibility:

• Required Baseplate: SenSura Mio Flex 35mm Skin Barrier (Red Coupling)
• NOT Compatible With: Click coupling baseplates (mechanical system)
• NOT Compatible With: Other flange sizes (40mm, 50mm, 60mm, 70mm)
• NOT Compatible With: Other brands (Hollister, ConvaTec, etc.)

Stoma Size Compatibility:

• 35mm Baseplate Opening Range: Typically available with openings 15-33mm
• Recommended Stoma Diameter: 25-33mm (with 2-3mm clearance on 35mm flange coupling)
• Ideal For: Larger mature stomas, some prolapsed stomas, bariatric patients
• Protrusion: All types (flush, protruding, retracted with appropriate baseplate convexity)

Performance Characteristics:

• Wear Time: Typically 18-36 hours (closed pouches changed after 1-2 bowel movements)
• Baseplate Wear: 3-5 days (change pouches 3-9 times on same baseplate)
• Temperature Tolerance: Stable 15-40°C (59-104°F)
• Water Resistance: Fully waterproof (shower, bath approved; swimming acceptable)
• Activity Level: Suitable for vigorous exercise, sports, manual labor
• Filter Lifespan: 24-48 hours typical (maintains odor control for expected closed pouch wear time)

Regulatory & Safety:

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

Color Coding System:

• Red Coupling Ring: Indicates 35mm flange size
• Coloplast Standard: Red = 50mm for drainable/urostomy; Red = 35mm for some closed pouch systems (check specific product line)
• Note: Color coding can vary by product line—always verify flange size on packaging

Packaging:

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

Usage Instructions

Pre-Application Requirements

1. Baseplate Must Be Applied First:

• CRITICAL: 2-piece pouches require matching baseplate already adhered to skin
• Verify you have SenSura Mio Flex 35mm baseplate applied (not Click, not other sizes)
• Baseplate should have been applied within last 3-5 days and still be securely adhered
• If baseplate is lifting, leaking, or past wear time: change baseplate before applying new pouch

2. Gather Supplies for Pouch Change:

• New SenSura Mio Flex 35mm closed pouch (Maxi capacity)
• Disposal bag for used pouch
• Tissue or toilet paper (for managing any immediate stoma output during change)
• Optional: Stoma wipe or damp cloth (if cleaning stoma during pouch change)

Pouch Attachment Process

1. Remove Old Pouch:

If Baseplate Has Output or Debris:

• Gently clean baseplate coupling area with damp cloth or stoma wipe
• Dry thoroughly with tissue
• Ensure coupling ring is completely clean and dry before attaching fresh pouch
• Check stoma for any bleeding, unusual appearance, or output

Flex System Removal:

• Support baseplate with one hand (place flat hand on skin around baseplate—prevents pulling on skin)
• With other hand, grasp top edge of pouch
• Gently pull pouch away from baseplate in peeling motion
• Start at top and work downward
• Flex adhesive releases gradually—be patient, don't yank
• If resistance encountered: very gently work the adhesive apart rather than forcing

2. Inspect Baseplate and Stoma:

• Check baseplate integrity: Edges should be fully adhered, no lifting, no moisture underneath
• Examine stoma: Should be pink/red, moist, no bleeding (minor bleeding during cleaning is normal)
• Inspect peristomal skin: Should be intact, same color as surrounding abdomen
• If problems noted: Address before attaching new pouch (may need baseplate change, skin treatment)

3. Prepare New Pouch:

• Remove pouch from packaging
• Check expiration date and verify 35mm Flex coupling
• Inspect coupling ring for any damage or contamination
• If pouch has been stored in cool place, warm between hands for 30-60 seconds (improves flexibility)

4. Attach Pouch to Baseplate:

Flex Coupling Technique:

• Hold pouch at top center with coupling ring facing baseplate
• Align red 35mm adhesive ring of pouch with red ring on baseplate
• Position coupling rings directly over each other (concentric circles)
• Ensure correct orientation (most users prefer pouch pointing downward toward feet)

Press Together:

• Starting at top (12 o'clock position): Press coupling rings together firmly
• Work your way around entire circumference: Press firmly all around the circle
• Unlike Click system, there is NO audible "click"—Flex coupling is silent
• Press firmly for 15-20 seconds around entire circle (Flex adhesive needs pressure to bond)
• Run fingers around entire coupling perimeter to ensure complete contact

5. Verify Secure Attachment:

• Visual inspection: Check that coupling is engaged all the way around (360 degrees)
• Gentle tug test: Very gently pull on pouch—should feel secure
• Wait 2-3 minutes for adhesive bond to strengthen before vigorous activity
• Check positioning: Pouch should hang naturally without pulling or twisting

Daily Wear & Monitoring

Monitoring During Wear:

Daily Inspection (Morning & Evening):

• Check pouch fullness (Maxi capacity holds more, but should change before completely full)
• Verify coupling connection secure (no gaps or lifting at edges)
• Monitor for any odor escape (filter saturation or coupling seal compromise)
• Assess baseplate integrity through coupling opening (visible peristomal skin should look healthy)

Signs of Normal Wear:

• Pouch gradually fills after bowel movement
• Filter prevents ballooning (pouch remains relatively flat)
• No odor when pouch is properly sealed
• Comfortable, no pulling or pressure sensations

Signs Requiring Attention:

• Coupling separation: Gap visible between pouch and baseplate rings
• Odor present: May indicate filter saturation (normal after 24-48 hours) or coupling seal failure
• Pouch very heavy or bulky: Time to change (Maxi holds 400-500g—becomes noticeable when 75%+ full)
• Baseplate lifting: Moisture visible under baseplate, edges lifting—time to change entire system
• Leakage: Output visible at coupling junction or baseplate edges—change immediately

When to Change the Pouch:

Typical Change Schedule for Closed Pouches:

• After each bowel movement: Many colostomy patients change within 1-6 hours after stoma becomes active
• Once daily: Common schedule—change each morning as part of daily routine
• Twice daily: Some patients prefer morning and evening changes for freshness
• Before social events: Fresh pouch for dates, meetings, travel for confidence
• As needed: Whenever pouch becomes 75%+ full or uncomfortable

Maxi Capacity Considerations:

• Maxi can hold 1-2 typical colostomy bowel movements comfortably
• Most users change after 1 bowel movement for hygiene (even though capacity allows 2)
• Extended capacity means less urgency—can delay change a few hours if needed
• Some users specifically choose Maxi to change only once daily (accommodate full day's output)

Expected Wear Time: 18-36 hours typical (most commonly 24 hours for once-daily changes)

Pouch Removal & Disposal

Removal Process:

1. Choose Time and Location:

• After bowel movement when pouch contains output (primary change trigger)
• Home bathroom ideal (privacy, sink, toilet)
• Public restrooms acceptable with proper supplies (disposal bag)

2. Detach Pouch from Baseplate:

• Support baseplate with one hand (prevents skin pulling)
• Grasp top of pouch with other hand
• Gently peel Flex coupling away from baseplate
• Work from top downward in smooth peeling motion
• Flex adhesive releases gradually—don't rush

3. Manage Baseplate After Pouch Removal:

• Baseplate remains on skin (this is the 2-piece advantage)
• Gently wipe baseplate coupling area if any output present
• Dry thoroughly before attaching fresh pouch
• Inspect stoma and peristomal skin while pouch is removed (opportunity for examination)

Disposal:

1. Closed Pouch Can Be Disposed With Contents:

• Closed pouches are designed for disposal with output inside (sealed system)
• Optional: Empty contents into toilet first (some users prefer, not required)
• To empty: Carefully open top of closed pouch, drain into toilet, then dispose of pouch

2. Seal and Contain:

• Fold pouch onto itself (contains any residual odor)
• Place in disposal bag (opaque, odor-proof bags commercially available)
• Seal disposal bag closed

3. Dispose in Household Trash:

• Closed pouches go in regular garbage (not recyclable)
• Don't flush pouches (will clog plumbing)
• Disposal bags minimize odor concerns in trash

4. Public/Institutional Settings:

• Standard trash receptacles acceptable
• Some facilities have sharps/biohazard bins (appropriate for ostomy waste)
• Always wrap in disposal bag for discretion