Description

The Bulkamid Urethral Bulking System is a specialized medical device designed to address stress urinary incontinence (SUI) in adult women, particularly those with intrinsic sphincter deficiency (ISD). This system is intended for those who have not found success with conservative treatments, offering a targeted solution through urethral injection to enhance urethral coaptation and minimize urinary leakage.

Components

The system includes:

• Two pre-filled 1 mL syringes of Bulkamid Hydrogel, composed of 2.5% cross-linked polyacrylamide and 97.5% non-pyrogenic water.
• A rotatable sheath (125 mm) equipped with channels for a needle, optic device, water tubing, and a Luer lock connector.
• Two sterile 23G x 12 cm injection needles.

These components are designed for single use and are sterile, ensuring safety and efficacy during the procedure. The system is used alongside a cystoscope and irrigation system, which are supplied separately.

Key Features

• Hydrogel Properties: The hydrogel is non-resorbable, transparent, hydrophilic, biocompatible, and non-biodegradable, making it suitable for long-term results.
• Minimally Invasive: The procedure is typically performed under local or general anesthesia and lasts about 10 to 15 minutes.
• Quick Recovery: Most patients can return to normal activities within 24 hours.

Procedure Details

Each session involves injecting 1.5 to 2.0 mL of hydrogel, with a maximum of 2 mL per session. Up to three treatment sessions may be conducted, with at least four weeks between each session. The hydrogel remains in the body over time, providing durable and lasting results.

Pre- and Post-Operative Care

• Pre-operative Recommendations: Urine testing, anesthesia, and prophylactic antibiotics.
• Assembly: Involves attaching the light cable and irrigation system to the cystoscope and sheath, priming the hydrogel syringe and needle, and removing air bubbles.
• Injection: The hydrogel is deposited into the submucosal tissue of the proximal urethra in 3 to 4 deposits.
• Postoperative Monitoring: Includes checking residual urine volume and, if necessary, intermittent catheterization.

Indications and Contraindications

The device is indicated for female urinary incontinence with a significant stress component. It should not be used in cases of acute urinary tract infection, cystitis, urethritis, active Herpes Genitalis, or damaged urethral tissue. It is not intended for male patients.

Warnings and Precautions

• Increased bleeding risk for patients on anticoagulant therapy.
• Avoid use after recent dental work or surgery, in patients with uncontrolled diabetes, or with acute or chronic infections.
• Not established for use during pregnancy, lactation, or in patients under 18.
• Administration should be conducted by qualified physicians only.

Adverse Events

Potential side effects include pain at the implant site, acute urinary retention, urinary tract infection, hematuria, dysuria, oedema, and scratching of the urethral mucosa. Rare events may include abscess formation, fibrosis, necrosis, and non-acute retention.

Storage Instructions

Store the device away from direct sunlight, do not freeze, and ensure it is used before the expiration date. The packaging should remain intact and undamaged before use, and the device should not be re-sterilized or reused.

Additional Information

The Demo Water Container Pitcher Bottle is utilized within the context of the Bulkamid Hydrogel injection system for demonstration or procedural purposes, enhancing the overall understanding and application of the system during medical procedures.