Two-piece ostomy bag - Urostomy bag (drainable) Amaris Medical
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Two-piece ostomy bag – Urostomy bag (drainable)

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A Two-piece ostomy bag – Urostomy bag (drainable) is a specialized, single-use appliance designed for the collection and management of urine following urinary diversion surgery (urostomy or ileal conduit) . This two-piece system consists of a drainable pouch that attaches to a separate baseplate (skin barrier/flange), allowing the baseplate to remain securely adhered to the peristomal skin while the pouch is emptied or replaced . The pouch is engineered specifically for urine with features not found on colostomy/ileostomy bags, including an integrated anti-reflux valve to prevent urine backflow toward the stoma (reducing urinary tract infection risk), a secure drainage tap for hygienic emptying, and a universal connector for overnight bedside drainage bag attachment .
The urostomy pouch features a mechanical coupling system (flex coupling or guided coupling) with an audible “click” confirming secure locking onto the baseplate. The anti-reflux valve is essential for infection prevention; when a patient lies flat during sleep, gravity can cause pooled urine to flow back toward the stoma, potentially introducing bacteria into the upper urinary tract . The drainage tap provides secure ‘open/close’ positions with a click lock, designed to leave no residual drops on fingers after emptying .
Constructed with multi-layer, 100% odor-proof film and covered with soft, breathable non-woven fabric (available in beige with inspection window or fully transparent options), the pouch is available in capacities from approximately 620 mL to 675 mL depending on flange size . The universal connector provided with each box features an anti-twist design for kink-free night drainage connection .
For the urologist and stoma care nurse, the two-piece urostomy system simplifies post-operative management following cystectomy for bladder cancer. For the patient, this appliance provides security, confidence, and the freedom to participate fully in daily activities while the anti-reflux valve and night drainage compatibility protect kidney function and prevent serious urinary infections .
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Description

Two-piece ostomy bag – Urostomy bag (drainable)

PRIMARY CLINICAL & DIAGNOSTIC USES

1. Post-Operative Urine Collection Following Urinary Diversion Surgery
  • Primary Use: Provides a specialized, single-use, drainable urostomy pouch designed to be attached to a two-piece ostomy baseplate (skin barrier/flange) for the collection of urine following surgical creation of a urinary diversion (urostomy or ileal conduit) .
  • How it helps: For the urologist and stoma care nurse, the two-piece urostomy system allows the baseplate to remain securely adhered to the skin while pouches are changed as needed. For the patient who has undergone cystectomy for bladder cancer or other urinary diversion procedures, this appliance provides a reliable, leak-resistant system for managing continuous urine flow. The two-piece design means the baseplate can stay in place for several days while the pouches are changed, significantly reducing skin trauma .
2. Anti-Reflux Valve for Urinary Tract Infection Prevention
  • Primary Use: Features an integrated anti-reflux valve that prevents urine from flowing back from the pouch toward the stoma, even when the patient is lying down or the pouch becomes full .
  • How it helps: For the urologist and infectious disease specialist, the anti-reflux mechanism is essential for reducing the risk of ascending urinary tract infections and pyelonephritis. When a patient sleeps in a supine position, gravity can cause pooled urine to flow back toward the stoma, potentially introducing bacteria into the upper urinary tract . For the patient, the anti-backflow design allows for uninterrupted sleep without compromising safety, significantly reducing the risk of serious urinary infections that can lead to hospitalization and kidney damage.
3. Secure Drainable Outlet with Night Drainage Compatibility
  • Primary Use: Equipped with a secure drainage tap (spout) that opens and closes with an audible click, designed for hygienic emptying of urine. The outlet includes a universal connector for attaching a night drainage bag, preventing pouch overfilling during sleep .
  • How it helps: For the ostomate, the drainable design is essential for managing the continuous flow of urine (approximately 400-800 mL every 24 hours) without needing to change the entire appliance multiple times daily. The secure tap allows for discreet, hygienic emptying in a standard toilet throughout the day. For overnight use, the universal connector enables connection to a larger bedside drainage bag, allowing gravity drainage throughout the night so the patient can sleep without waking to empty the pouch .
4. Two-Piece Mechanical Coupling for Secure Attachment
  • Primary Use: Features a guided mechanical coupling system (flex coupling) that securely attaches the urostomy pouch to the matching baseplate flange. The system provides an audible click confirming secure locking .
  • How it helps: For the clinician and patient, the mechanical coupling provides a secure, leak-proof connection that can be trusted during daily activities. The audible click confirms that the pouch is properly locked in position, eliminating guesswork and providing peace of mind. A floating flange design prevents discomfort during pouch attachment by distributing pressure away from the sensitive peristomal area.

SECONDARY & SUPPORTIVE USES

1. Integration with Night Drainage Systems: The drainable outlet can be connected to a larger overnight urine collection bag (bedside drainage bag) using the universal connector provided in the box, allowing gravity drainage throughout the night so the patient can sleep without waking to empty the pouch .
2. Two-Piece System Benefit: Pouch Changes Without Baseplate Removal: The baseplate remains in place for extended wear (2-7 days) while the drainable pouch is emptied multiple times daily; the pouch itself can be changed without disturbing the skin seal, reducing skin trauma and lowering supply costs .
3. Post-Cystectomy Bladder Cancer Management: Provides essential post-operative urinary management for patients who have undergone radical cystectomy for muscle-invasive bladder cancer, the most common indication for urostomy surgery .
4. Management of Neurogenic Bladder with Incontinence: Used as a urinary diversion option for patients with severe neurogenic bladder (spinal cord injury, spina bifida, multiple sclerosis) who cannot manage intermittent catheterization or who have failed other incontinence treatments.
5. Protection Following Trauma or Pelvic Surgery: Used in patients requiring temporary or permanent urinary diversion following pelvic trauma, radiation injury, or complications from pelvic surgery that compromise normal bladder function.
6. Leg Bag Compatibility for Daytime Use: Compatible with leg drainage bags for daytime use when access to a toilet for emptying is limited (e.g., during travel, long car journeys, or work situations) .
7. Opaque and Transparent Options: Available in opaque beige with inspection window for discretion, or fully transparent for clinical assessment in the post-operative period .
8. Soft Fabric Backing for Comfort: Features soft, breathable non-woven fabric covering the body-facing side to reduce friction, noise, and moisture against the skin; available in beige or split cover designs .
9. Post-Operative Monitoring of Urine Output: Used in the immediate post-operative period to measure and record urine output volume, providing clinicians with valuable data on kidney function, hydration status, and recovery.
10. Anti-Twist Design for Night Drainage Connection: The universal connector features an anti-twist design that prevents kinking of the night drainage tubing, ensuring uninterrupted urine flow during sleep .
11. Material Safety and Latex-Free: Manufactured without natural rubber latex and phthalates (DEHP-free), making it safe for patients with latex allergies .
12. Odor-Proof Construction: Multi-layer film provides 100% odor-proof barrier, preventing urine odour from escaping the pouch.
13. FLOWASSIST Technology Option: Some two-piece urostomy pouches feature FLOWASSIST technology—a unique spout that directs output into the pouch and a non-absorbent shield that protects delicate peristomal skin and prevents adhesive breakdown—particularly beneficial for patients with irregular or difficult stomas .
14. Ostomy Belt Compatibility: Many two-piece systems are compatible with ostomy belts that clip onto the baseplate flange, providing additional security and support during physical activities .
15. Child and Adolescent Use: Smaller-sized pouches and baseplates are available for paediatric patients requiring urinary diversion; as the child grows, the pouching system may need to be adjusted .
16. No Residual Drops Design: The drainage tap is designed to leave no residual drops on fingers after emptying, improving hygiene and convenience .
17. Pre-Cut and Cut-to-Fit Options: Available with precut holes in a range of sizes (typically 45mm, 55mm, 65mm flange diameters) or with starter holes that can be cut to fit individual stoma sizes .
18. Capacity Options (ISO 8670-2 Certified): Available in capacities ranging from approximately 620 mL to 675 mL depending on flange size .
KEY PRODUCT FEATURES

1. BASIC IDENTIFICATION ATTRIBUTES

  • Device Type: A single-use, drainable urostomy pouch designed to be attached to a two-piece ostomy baseplate (skin barrier/flange), specifically engineered for urine collection following urinary diversion surgery .
  • Designation: Two-piece urostomy bag, urostomy pouch, ileal conduit bag, urinary stoma bag, two-piece drainable urostomy appliance.
  • Key Components:
    • Pouch Body: A leak-proof, 100% odor-proof collection chamber made of multi-layer film (including EVOH), designed for urine collection
    • Mechanical Coupling (Flange Ring): A plastic ring (flex coupling or guided coupling) that snaps onto the matching ring on the baseplate, providing a secure, audible lock 
    • Anti-Reflux Valve: Integrated valve that prevents urine from flowing back toward the stoma, reducing infection risk 
    • Drainage Tap (Spout): Secure outlet with 'open' and 'close' positions; features an audible click when fully closed 
    • Universal Connector: Provided connector for attaching to night drainage bags; features anti-twist design 
    • Filter: Some models include an integrated activated charcoal filter to vent gas while containing odor
    • Comfort Layer: Soft, breathable non-woven fabric covering the body-facing side to reduce friction and moisture 
    • Inspection Window: Transparent film section allowing for output monitoring without pouch removal

2. TECHNICAL & PERFORMANCE PROPERTIES

  • GMDN Term Definition: Two-piece ostomy bag. A device designed to be attached to a base plate as a receptacle for urinary output following a urostomy. The device consists of a pouch designed to be attached, via a flange, to a base plate. The proximal end of the device is open to the stoma and the distal end is openable for drainage (drainable). Typically, it is intended to be replaced one to three times per day .
  • FDA Product Code: EXG (Bag, Urine Collecting, Ureterostomy)
  • Capacity (ISO 8670-2 Certified):
    • 45mm flange: approximately 675 mL 
    • 55mm flange: approximately 635 mL 
    • 65mm flange: approximately 620 mL 
  • Coupling Type: Mechanical (flex coupling or guided coupling) with audible click confirmation; available flange diameters: 45mm, 55mm, 65mm 
  • Anti-Reflux Valve: Integrated valve prevents urine backflow 
  • Drainage Tap: Secure 'open/close' positions with click locking; designed for no residual drops on fingers 
  • Night Drainage Compatibility: Universal connector with anti-twist design for connection to bedside drainage bag 
  • Body-side Covering: Soft non-woven fabric; available in beige with inspection window or transparent option 
  • Sterility: Non-sterile; intended for use on clean, intact peristomal skin with a properly adhered baseplate
  • Single-Use: Intended for single patient use only; the pouch is emptied multiple times but discarded when soiled or after recommended wear time
  • Latex-Free: Manufactured without natural rubber latex 
  • DEHP-Free: Manufactured without phthalates 
  • Product Characteristics: Drainable, odour-proof, non-sterile, single-use, with anti-reflux valve
  • Packaging: Box of 30 urostomy bags and 30 universal connectors 

3. PHYSICAL & OPERATIONAL PROPERTIES

  • Configuration: Part of a two-piece system where the urostomy pouch and baseplate are separate components attached via a mechanical coupling; the pouch can be emptied multiple times and exchanged while the baseplate remains on the skin .
  • Appearance: Opaque beige with inspection window (for discretion) or fully transparent (for clinical assessment) .
  • Flexibility: Flexible pouch design that conforms to body movement; soft non-woven fabric is comfortable against the skin .
  • Flange Diameters: Available in 45mm, 55mm, and 65mm to match corresponding baseplate sizes .
  • Wear Time (Pouch): The drainable pouch is emptied multiple times daily and typically replaced every 1-3 days. The baseplate remains in place for 2-7 days while pouches are exchanged .
  • Wear Time (Baseplate): 2-7 days depending on product line and patient anatomy.
  • Packaging: Individually wrapped; sold in boxes of 30 pouches with 30 universal connectors .
  • Output Monitoring: Inspection window allows urine output assessment without removing pouch.
  • Odor Control: Multi-layer film provides 100% odor-proof barrier.
  • Application: Attach to the coupling ring of the baseplate, press until audible click confirms secure locking.
  • Emptying Procedure (Drainable Pouch):
    • Sit with pouch between legs 
    • Open drainage tap (turn or unclip)
    • Empty contents into toilet
    • Wipe outlet clean
    • Close drainage tap until audible click confirms secure seal
    • Wash hands thoroughly
  • Night Drainage Connection: Attach universal connector to drainage tap; connect to bedside drainage bag; ensure tubing is not kinked .

4. SAFETY & COMPLIANCE ATTRIBUTES

  • Regulatory Status: Class I medical device (FDA Product Code EXG - Bag, Urine Collecting, Ureterostomy). CE marked for European market .
  • Quality Standards: Complies with international ostomy standards (ISO 8670-2); manufactured under quality management systems (ISO 13485).
  • Biocompatibility: Manufactured with skin-friendly, hypoallergenic, non-irritating materials; hydrocolloid-free (the pouch itself does not contact the skin; the baseplate provides skin adhesion).
  • Urinary Tract Infection Prevention: Anti-reflux valve prevents retrograde urine flow, reducing UTI risk .
  • Odor Control: Certified to meet odor-barrier efficacy standards using multilayer high-barrier co-extrusion membrane.
  • Latex-Free: Manufactured without natural rubber latex to accommodate patients with latex allergies .
  • DEHP-Free: Manufactured without phthalates .
  • Storage: Store in a cool, dry place away from direct heat and sunlight, which can degrade the materials.
  • Expiration: Shelf life typically 3 years; check packaging for expiration date.

5. STORAGE & HANDLING ATTRIBUTES

  • Storage: Store in a cool, dry place at room temperature below 25°C / 77°F. Avoid exposure to direct sunlight, extreme heat, or humidity, which can degrade the plastic film, anti-reflux valve, and closure mechanism. Keep out of reach of children.
  • Shelf Life: Typically 3 years from the date of manufacture when stored properly; check individual packaging for expiration date.
  • Skin Preparation: Peristomal skin must be clean, completely dry, and free of lotions, oils, or adhesive residue before application to ensure proper adhesion of the baseplate.
  • Baseplate Application: Apply baseplate (which must be ordered separately) to clean, dry peristomal skin . Center opening over stoma without gap larger than 3mm (1/8 inch) .
  • Pouch Attachment: Align coupling ring with baseplate flange; press together firmly until audible "click" confirms secure locking.
  • Pouch Removal (Emptying):
    • Sit down with pouch between legs to avoid splashing 
    • Open drainage tap (turn to 'open' position)
    • Empty contents into toilet
    • Wipe outlet clean
    • Close tap until audible click confirms secure seal
  • Pouch Removal (Discarding): Press release tabs on coupling ring to detach used pouch. The baseplate remains adhered to the skin. Dispose of used pouch in general waste per local regulations. Do not flush .
  • Night Drainage Setup: Attach universal connector to drainage tap; connect to bedside drainage bag; ensure tubing is not kinked and that the drainage bag is positioned lower than the bladder to allow gravity drainage .
  • Leg Bag Attachment: For daytime use when toilet access is limited, attach leg drainage bag compatible with the universal connector .

6. LABORATORY & CLINICAL APPLICATIONS

  • Primary Application: Collection and management of urinary effluent following urinary diversion surgery (urostomy, ileal conduit) in patients who have undergone cystectomy for bladder cancer or other conditions requiring urinary diversion .
  • Clinical Role: Essential post-operative and long-term care device in urology, uro-oncology, and home healthcare for the management of patients with a urinary stoma; also applicable for patients with neurogenic bladder or other conditions requiring urinary diversion.
SAFETY HANDLING PRECAUTIONS

1. SAFETY PRECAUTIONS

  • Sterility/Baseplate: Baseplate (sold separately) is non-sterile; intended for use on clean, intact peristomal skin.
  • Anti-Reflux Valve Function: Do not obstruct the anti-reflux valve; proper function is essential for preventing urinary tract infections .
  • Customization: The baseplate opening must be cut to the correct size—no larger than 3 mm (1/8 inch) of the stoma. An opening that is too large will expose peristomal skin to corrosive urine and cause breakdown .
  • Monitor for Leaks: Change the appliance immediately if any urine is observed leaking under the baseplate to prevent skin damage.
  • Night Drainage Precautions: When using a bedside drainage bag, ensure the tubing is not kinked and that the drainage bag is positioned lower than the bladder to allow gravity drainage. Failure to do so may cause backflow and increase infection risk .
  • Leg Bag Precautions: If using a leg drainage bag, empty when full; wash the bag after each use with warm water or a vinegar solution (1/4 cup white vinegar to 1 cup water) and allow to air dry .
  • Showering and Swimming: The pouch can be worn while showering; when swimming, use a swim belt or waterproof tape to secure the edges. The universal connector can be capped or covered.
  • Signs of Skin Breakdown: Discontinue use and consult a stoma care nurse if the peristomal skin becomes red, weepy, raw, or itchy, indicating possible fungal infection, contact dermatitis, or adhesive allergy .
  • Hydration Monitoring: Urostomy patients are at risk for dehydration and electrolyte imbalance; monitor urine output volume and color, and maintain adequate fluid intake.
  • Signs of Urinary Tract Infection: If the patient develops fever, chills, flank pain, cloudy or foul-smelling urine, or increased leakage, evaluate for UTI and consult a clinician promptly.
  • Pre-existing Allergies: Patients with known adhesive sensitivities or latex allergies should use appropriate baseplate and pouch materials (latex-free options are available) .
  • Do Not Reuse Pouch: This is a single-use device; do not attempt to wash, resterilize, or reapply a used pouch. Leg drainage bags can be reused if properly cleaned .

2. FIRST AID MEASURES

  • Adhesive Allergy: If signs of an allergic reaction (rash, severe itching, blistering) occur at the adhesive site, remove the appliance immediately, gently cleanse the skin with warm water, discontinue use of that brand, and consult a clinician .
  • Leakage: If a leak occurs, remove the appliance immediately, gently cleanse the skin with warm water, dry thoroughly, and apply a new baseplate and pouch. If leakage recurs, consult a stoma care nurse to reassess stoma size and baseplate fit.
  • Signs of Urinary Tract Infection: If the patient develops fever, chills, flank pain, cloudy or foul-smelling urine, or increased leakage, evaluate for UTI and consult a clinician promptly.
  • Bleeding Stoma: If the stoma bleeds when cleaning (common due to its high vascularity), apply gentle pressure with a clean, dry gauze pad for a few minutes. Contact a clinician if bleeding is profuse or does not stop.
  • Clogged Overnight Drainage Tubing: If the bedside drainage bag tubing becomes clogged with mucus, gently irrigate with warm water or replace the bag as needed.

3. FIRE FIGHTING MEASURES

  • Flammability: The plastic pouch and non-woven fabric are combustible. Keep away from open flames and direct heat sources.
  • Extinguishing Media: Use water, foam, CO₂, or dry chemicals for fires involving combustible material. The pouch presents no special fire hazard beyond typical medical plastics.
  • Storage Warning: Do not store ostomy supplies near radiators, heating vents, or in vehicles during hot weather, as extreme heat can degrade the adhesive, plastic film, and anti-reflux valve.

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