Name of the Procedure:

Injection, hexaminolevulinate hydrochloride, 100 mg, per study dose (C9275)

Summary

This procedure involves an injection of a drug called hexaminolevulinate hydrochloride. It is often used in diagnostic imaging, particularly for visualizing the bladder during cystoscopy, which helps in the detection of bladder cancer.

Purpose

The primary purpose of this injection is to visualize abnormalities in the bladder lining. It helps in identifying bladder cancer at an early stage, making it easier to treat effectively. The goal is to improve diagnostic accuracy and guide appropriate treatment planning.

Indications

• Patients with symptoms such as blood in urine, frequent urination, or urinary urgency that suggest bladder cancer.
• Individuals with a history of bladder cancer undergoing follow-up assessments.

Preparation

• Patients may be required to fast for a few hours before the procedure.
• They should inform their healthcare provider about any medications they are taking, as some might need to be adjusted.
• A brief medical history and physical examination will be conducted.

Procedure Description

1. Initial Preparation: The patient is positioned comfortably, often in a lithotomy position.
2. Injection: Hexaminolevulinate hydrochloride is injected into the bladder through a catheter.
3. Action Period: The drug is allowed to dwell in the bladder for about an hour, during which it is absorbed by cancerous cells, causing them to fluoresce.
4. Cystoscopy: A cystoscope equipped with a special light is inserted into the bladder to visualize it. Cancerous cells will fluoresce, aiding in detection.

No anesthesia is typically required, but local anesthesia may be used for patient comfort during catheter insertion.

Duration

The entire procedure, including preparation and action period, usually takes about 2 hours.

Setting

This procedure is performed in a hospital or outpatient clinic that has facilities for cystoscopy.

Personnel

• Urologist or trained medical specialist
• Nurses for preparation and aftercare
• Technicians operating the cystoscopy equipment, if needed

Risks and Complications

• Possible urinary tract infection (UTI)
• Mild discomfort or pain during and after the procedure
• Rare allergic reactions to the drug
• Minor bleeding or irritation in the bladder

Benefits

• Enhanced visualization of bladder cancer cells
• Early detection and treatment of bladder cancer
• Non-invasive and generally well-tolerated

Recovery

• Patients can usually go home the same day.
• Drink plenty of fluids to flush out the bladder.
• Mild discomfort may be managed with over-the-counter pain relievers.
• Follow-up appointments are typically scheduled within a few weeks to discuss results and further treatment.

Alternatives

• Standard white-light cystoscopy, which is less effective at detecting certain types of cancerous cells.
• Urine cytology tests, although they may be less accurate.
• Imaging studies such as CT scans, which are more invasive or less specific.

Patient Experience

During the procedure, patients may feel slight discomfort from the catheter insertion but should not feel significant pain. Afterward, it is common to experience mild burning or urgency when urinating, which usually resolves within a day or two. Pain management includes fluids, mild pain relievers, and comfort measures advised by healthcare providers.