Introduction
Bladder health plays a vital role in maintaining comfort and urinary function. However, conditions like interstitial cystitis (IC), radiation cystitis, and chronic inflammation can severely damage the bladder's protective glycosaminoglycan (GAG) layer. When this layer is compromised, the bladder wall becomes vulnerable to irritants in the urine, leading to pain, urgency, and frequent urination.
To address this, Singclean® Sterile Sodium Hyaluronate Solution for GAG Layer Replacement offers a safe, effective, and biocompatible treatment to restore the bladder's natural defense.
Product Overview
Singclean® Sterile Sodium Hyaluronate Solution for GAG Layer Replacement is a sterile, high-purity hyaluronic acid (HA) formulation designed for intravesical instillation. It serves as a temporary replacement for the damaged GAG layer of the bladder mucosa, providing protection and relief for patients with bladder inflammation or interstitial cystitis.
Product Name: Singclean® Sterile Sodium Hyaluronate Solution for GAG Layer Replacement
Specification: 20 mL per vial (2 mg/mL high concentration)
Application: Temporary restoration of the bladder's GAG protective layer
This medical solution supports mucosal repair, relieves bladder pain, and enhances patient comfort through natural biocompatibility and safety.
Clinical Applications
This sterile sodium hyaluronate solution is widely used in the treatment and management of:
- Interstitial cystitis / bladder pain syndrome (IC/BPS)
- Chronic and recurrent bacterial cystitis
- Radiation cystitis following radiotherapy for prostate, bladder, or cervical cancers
- Chemical cystitis resulting from chemotherapy or intravesical drug irritation
By replenishing the bladder's protective coating, the product helps to alleviate pain, reduce urinary frequency and urgency, and prevent further epithelial damage.
Mechanism of Action
The bladder's mucosal layer contains the GAG layer, composed of hyaluronic acid, chondroitin sulfate, heparin, dermatan sulfate, and keratan sulfate. This layer acts as a barrier against harmful substances in urine, maintaining the mucosa's integrity and impermeability.
When the GAG layer is damaged, irritants can penetrate deeper tissues, causing inflammation and pain.
Singclean® Sterile Sodium Hyaluronate Solution restores this barrier through two main mechanisms:
- Exogenous HA supplementation:
The high-molecular-weight hyaluronic acid replenishes lost GAGs, restoring the bladder's hydrophilic surface and improving mucosal defense.
- Formation of a viscoelastic protective film:
The HA solution forms a thin elastic layer on the bladder wall, preventing harmful substances from contacting epithelial cells, thus reducing inflammation and promoting healing.
This mechanism ensures rapid symptom relief and long-term mucosal protection with minimal side effects.
Product Specifications
| Concentration | 2 mg/mL high molecular weight HA |
| Volume | 20 mL prefilled syringe per vial |
| Form | Sterile, ready-to-use solution for intravesical instillation |
| Storage | Store in a cool, dry place away from direct sunlight |
Each unit is designed for single use to maintain sterility and prevent contamination.
Product Advantages
Singclean® Sterile Sodium Hyaluronate Solution offers several advantages over conventional GAG replacement products:
- Higher Concentration and Molecular Weight:
Compared to imported brands such as Cystistat®, Singclean's higher viscosity formulation forms a more stable and longer-lasting film on the bladder wall.
- Convenient Packaging:
Pre-filled syringe design simplifies the instillation process for healthcare professionals and reduces preparation time.
- Optimized Volume:
Each 20 mL vial minimizes waste - one vial is suitable for standard therapy, and two vials may be used for severe cases.
- Superior Biocompatibility:
The solution is free from animal-derived components, ensuring low immunogenicity and excellent tissue compatibility.
- Safe and Effective Relief:
Clinical experience indicates rapid symptom improvement within several treatment cycles, with minimal adverse reactions.
Instructions for Use
Bladder Preparation:
The patient should completely empty the bladder before instillation.
Catheterization:
The physician connects the prefilled syringe to the catheter connector and inserts it into the bladder.
Injection:
20 mL of the HA solution is instilled slowly over 1–2 minutes to minimize irritation.
Solution Retention:
The patient should retain the solution for at least 30 minutes, changing position every 5 minutes to ensure even distribution.
Discharge:
After the retention period, the solution can be expelled naturally.
The treatment is typically administered once a week for 4 weeks, then once a month for maintenance, depending on patient response.
Precautions
- Use only under medical supervision by trained professionals.
- Do not use if the package is damaged or the solution appears cloudy.
- Single-use only - discard any remaining product after instillation.
- Avoid concurrent use with antiseptic solutions that may degrade hyaluronic acid.
- Not suitable for patients with known hypersensitivity to HA or any excipients.
FAQ
Q: 1. Can sample be sent free?
A: For quality reference, we can supply samples for free. But the freight will be collected. If you need samples with your logo, you need to pay the charges of making plate, charges of printing foil and charges of printing box.
Q: 2. Can I have my own brand?
A: Yes, OEM is acceptable.
Q: 3. Can you meet the regulation requirement of EU market?
A: Yes, our products are of EU regulation compliant.
Q: 4. Which market you exported before?
A: We have exported to countries of Europa, South America, Africa, Middle east and Southeast Asia.
Q: 5. Do you have a complete QC management systems?
A: Yes, we have IQC (Incoming Quality Control), PQC (Producing Quality Control), LQC (Line Quality Control) and FQC (Final Quality Control).
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