Description
The NONSTERILE NEEDLE BULKAMID is an integral component of the Bulkamid Urethral Bulking System, specifically designed for medical professionals treating stress urinary incontinence (SUI) in adult women. This specialized needle facilitates the precise injection of Bulkamid Hydrogel, addressing intrinsic sphincter deficiency (ISD) by enhancing urethral coaptation.
Key Features
- Gauge and Length: The needle features a 23G gauge and a 12 cm length, providing the necessary specifications for accurate periurethral and transurethral injections.
- Single-Use Design: It is intended for single use only, ensuring sterility and reducing the risk of cross-contamination. Reuse or re-sterilization is not recommended.
- Sterilization: Each needle is sterilized using ethylene oxide and comes peel packed, maintaining its non-pyrogenic status.
- Insertion Guidance: Equipped with 1 cm markings, the needle aids in controlling insertion depth, enhancing precision during the procedure.
- Compatibility: It connects seamlessly to the prefilled Bulkamid Hydrogel syringe via a Luer lock socket and is used in conjunction with a cystoscope, which is not included in the kit.
Usage Instructions
The procedure typically involves injecting the hydrogel into the submucosal tissue of the urethra under cystoscopic control. This minimally invasive approach is usually performed under local anesthesia, with 2-4 deposits of hydrogel placed as needed. The entire process generally takes 10-15 minutes, allowing for rapid recovery.
Storage and Handling
Proper storage is crucial; the needle should be kept away from direct sunlight and should not be frozen. Following use, it must be disposed of as a potential biohazard in accordance with medical regulations.
Clinical Benefits
The use of the NONSTERILE NEEDLE BULKAMID has shown significant efficacy in reducing urine leakage and incontinence episodes, with a low complication rate. Most adverse events, such as urinary tract infections, are minor and resolve quickly, not affecting future treatment options.
This product is intended for use by trained healthcare providers in a clinical setting, contributing to improved patient outcomes through enhanced procedural accuracy and safety.
