Understanding Optilume® for Treating Benign Prostate Hyperplasia (BPH)

What is Optilume®?

Optilume® is a medical device designed to treat BPH by combining a medication-coated balloon with advanced balloon dilation techniques. This device opens the urethra, reducing urinary symptoms and preventing the recurrence of urethral strictures.

How does Optilume® work?

Optilume® is a minimally invasive procedure that involves the following steps:

1. Preparation: The patient is lightly sedated and given local anaesthesia while lying on their back with legs in stirrups.
2. Insertion: A catheter system is inserted into the urethra and guided to the prostate.
3. Balloon Inflation: Once in place, a cylindrical balloon is inflated, pressing against the prostate tissue to create a wider channel for urine flow.
4. Drug Delivery: The balloon is coated with an antiproliferative medication, which is released directly into the micro fissures created in the tissue. This medication helps to reduce cell growth and prevent the formation of fibrotic scar tissue.

What are the benefits of Optilume®?

Optilume® offers several significant benefits for men suffering from BPH or lower urinary tract symptoms:

• Minimally Invasive: The procedure is performed with minimal invasion, requiring no permanent implants or tissue removal.
• Reversible: Unlike some treatments, Optilume® does not cause irreversible changes to the prostate or surrounding tissues.
• Long-lasting Relief: Patients often experience sustained relief from urinary symptoms.
• Low Risk: There is a minimal risk of complications or side effects, making it a safer alternative to traditional surgeries.
• Quick Procedure: The entire process is quick and can be performed in a clinical setting, reducing the need for hospital stays and extensive recovery periods.

Are there any risks associated with Optilume®?

While Optilume® is generally safe, some risks and potential side effects should be considered:

• Discomfort or Pain: Some patients might feel discomfort during the procedure, especially if the balloon is overinflated.
• Urinary Tract Infection (UTI): There is a low risk of developing a UTI post-procedure.
• Bleeding or Bruising: Minor bleeding or bruising in the urethra or surrounding tissues can occur but typically resolves without intervention.

How effective is Optilume®?

Results from the PINNACLE Study

The PINNACLE study assessed patient outcomes two years after treatment with the Optilume BPH Catheter System. Here are the key findings:

• Symptomatic Improvement: At two years, 67.5% of participants in the Optilume BPH arm were symptomatic responders, defined by a ≥30% improvement in the International Prostate Symptom Score (IPSS) without needing additional medical or surgical treatment.
• IPSS Scores: Improved significantly from an average of 23.4 to 11.0.
• Urinary Flow Rate (Qmax): Increased by 116.8%, from 8.9 to 19.0.
• Post-Void Residual Urine (PVR): Showed a slight reduction from 83.7 to 65.9.
• BPH-II Scores: Improved by 53.9%, from 7.0 to 2.3.
• Quality of Life (QoL): Improved from 4.6 to 2.2.

Safety and Adverse Events

The most common adverse events in the Optilume BPH arm were hematuria (blood in urine) and urinary tract infections. However, no device or treatment-related serious adverse events were reported beyond 12 months post-procedure. Additionally, there was no impact on sexual function, making Optilume® a safe and tolerable treatment option.

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What are recognised standard surgical treatments for an enlarged prostate?

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TURP (transurethral resection of the prostate)

UroLift

Rezum

Aquablation‍

HoLEP (Holmium Laser Enucleation of the Prostate)

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Reflection from a prostate specialist

Optilume® represents a significant advancement in the treatment of BPH, providing a minimally invasive, effective, and safer alternative to traditional therapies. The PINNACLE study confirms its long-term benefits, demonstrating durable and lasting results comparable to more invasive treatments. For men seeking relief from BPH symptoms without the risks associated with surgery, Optilume® offers a promising solution. Even though Optilume has shown benefit in urethral strictures it is still early days to know the effectiveness for treating an enlarged prostate but the results are promising.

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