Name of the Procedure:

• Procedure Name: Instillation of Hexaminolevulinate Hydrochloride
• Common Name: Hexvix/Cysview Instillation
• Technical/Medical Term: A9589: Instillation, Hexaminolevulinate Hydrochloride, 100 mg

Summary

The instillation of hexaminolevulinate hydrochloride involves applying a special dye into the bladder to help detect bladder cancer. This dye makes cancerous cells glow under blue light, allowing doctors to see abnormal tissue more clearly during a cystoscopy.

Purpose

• Medical Conditions Addressed: Primarily used for the detection and diagnosis of bladder cancer.
• Goals/Outcomes: Early and accurate identification of cancerous cells in the bladder, aiding in appropriate and timely treatment.

Indications

• Symptoms/Conditions: Patients with symptoms such as blood in urine (hematuria), frequent urination, pain during urination, and other signs that suggest bladder abnormalities may undergo this procedure.
• Patient Criteria: Individuals with a high risk of bladder cancer or those being monitored after a previous bladder cancer treatment.

Preparation

• Pre-Procedure Instructions:
  • Patients may be instructed to refrain from eating or drinking for a few hours before the procedure.
  • They may need to avoid certain medications as advised by their healthcare provider.
• Diagnostic Tests: A standard urine test and possibly imaging tests might be required before the procedure to assess the bladder's condition.

Procedure Description

1. Initial Steps: The patient is asked to empty their bladder.
2. Dye Instillation: A catheter is inserted into the bladder via the urethra, and hexaminolevulinate hydrochloride is instilled through it.
3. Dye Retention: The patient retains the dye in their bladder for about 60 minutes.
4. Cystoscopy: A cystoscope (a special scope with a camera) is inserted into the bladder, and the abnormal cells that absorb the dye are examined under blue light, which makes them glow.
   • Tools/Equipment: Catheter, hexaminolevulinate hydrochloride solution, cystoscope with blue-light capability.
   • Anesthesia/Sedation: Local anesthesia may be used to minimize discomfort during catheterization and cystoscopy.

Duration

The entire procedure, including preparation, dye retention, and cystoscopy, typically takes about 1.5 to 2 hours.

Setting

This procedure is usually performed in a hospital or an outpatient clinic with appropriate facilities for diagnostic cystoscopy.

Personnel

• Healthcare Professionals Involved: Urologist (specialist in urinary tract issues), nurses, potentially an anesthesiologist if sedation is used.

Risks and Complications

• Common Risks: Mild pain or discomfort during urination post-procedure, bladder spasms.
• Rare Complications: Urinary tract infection, allergic reaction to the dye, bleeding.

Benefits

• Expected Benefits: Enhanced visibility of bladder tumors, resulting in more accurate diagnosis and better treatment planning.
• Timing: The benefits can be seen immediately during the cystoscopy once the glowing areas are identified.

Recovery

• Post-Procedure Care: Patients may be instructed to drink plenty of fluids to flush out the dye and reduce any discomfort.
• Recovery Time: Most patients can return to normal activities within a day.
• Restrictions/Follow-Up: Avoid strenuous activities for 24 hours and follow up with the healthcare provider as advised.

Alternatives

• Other Treatment Options:
  • Standard white-light cystoscopy without dye.
  • Urine cytology tests.
  • Imaging tests (e.g., CT urogram).
• Pros and Cons: Alternative methods might be less invasive but may not provide the same level of diagnostic accuracy as the hexaminolevulinate hydrochloride instillation.

Patient Experience

• During the Procedure: Patients may feel mild discomfort during dye instillation and cystoscopy.
• Post-Procedure: There may be some pain during urination and additional urges to urinate for a short period, managed with over-the-counter pain relief and hydration.