Highlights
- A study published in September 2023 found a new treatment for benign prostatic hyperplasia to be safe and effective.
- The Optilume BPH catheter system uses a drug-coated balloon to separate an enlarged prostate from the urethra. It also delivers a drug that limits further prostate growth, easing urinary symptoms from BPH over a longer period of time.
- Unlike other surgical treatments for BPH, Optilume showed no effect on sexual functioning.
- There are other options for BPH treatment, and men should consider their options carefully.
A study published in September 2023 offers new hope for BPH sufferers.
The PINNACLE Study, published in the Journal of Urology, looked at a new, minimally invasive surgical device for the treatment of lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH.)
The device, called the Optilume BPH Catheter System, shows promise to help treat LUTS with minimal impact and effective long-term results. In this article, we’ll talk about Optilume, the study and its implications, and how this device may be able to help people with BPH live more normally.
But first, a bit about LUTS.
What Are LUTS?
If you have benign prostatic hyperplasia (BPH), you may know that around age 25, the prostate begins growing after a brief pause after puberty, then continues to grow for the rest of your life. The prostate surrounds your urethra, or urinary tract, and once it reaches a certain size, your prostate can begin compressing it, interfering with normal urination.
LUTS is the short name for the lower urinary tract symptoms caused by BPH. These symptoms can include:
- More frequent urination
- A sudden and urgent need to urinate
- Regular need to urinate overnight (nocturia)
- Difficulty urinating
- Weak or intermittent urination
- Incomplete emptying of the bladder
LUTS become more common in men they age; more than 80% of men over 80 have BPH.
Until now, the options for treatment have generally been surgical procedures, which have enough drawbacks that many men choose to simply go on living with the symptoms.
Optilume takes a different approach.
How Does Optilume Work?
Optilume is an FDA-approved medical device consisting of a surgical balloon coated with paclitaxel, a drug that stops cell division. The balloon is inserted into the rectum and inflated to push the prostate away from the urethra. The balloon remains inflated for about ten minutes. After removal, the paclitaxel limits prostate growth, providing long-term relief of LUTS.
Optilume was designed to be minimally invasive, so healing times are shorter than with BPH procedures, and there’s less post-surgical difficulty as the body heals. The new study has shown just how effective the procedure actually is.
What Does The PINNACLE Study Say About Optilume?
The PINNACLE study was conducted using a double-blind method, so neither the researchers nor the patients knew if they were getting the treatment, with the men in the study randomly assigned to one of two groups. Then they tested the results using patient surveys and uroflowmetry. The study participants were then followed over the course of a year.
Long-Term Results
The men who underwent the procedure reported a significant improvement in symptoms — an average of 30%. That improvement was reflected in urine tests, which showed a Qmax (urine flow) improvement of 10 milliliters per second (mL/s) over presurgical rates a year later.
The study also showed no impact on sexual function, with no effect on either erections or ejaculation — a significant improvement over many more-invasive treatments.
Adverse Events
Five study participants experienced serious side effects related to the treatment device. These included four cases of post-procedure bleeding in the urine, which were treated and resolved without any lasting issues. There was also one case of a false passage in the urethra, which required prolonged catheterization.
The group that received the Optilume BPH treatment experienced some side effects that included bleeding in the urine, urinary tract infections, pain during urination, and various types of incontinence. These side effects were usually mild to moderate in severity and typically went away within a month.
Study Conclusion: Optilume is Safe and Effective for the Treatment of BPH
In short, the study showed that the procedure was safe and that it worked over a long period of time. So what does this mean for men with BPH?
Optilume, BPH, and The Right Choice For You
For men with BPH, likely the most important aspect of the surgery is the preservation of sexual function and prevention of urinary strictures. To this point, the most effective surgeries have gone through the urethra and either sliced away prostate tissue, or killed some of it using lasers, ultrasound, or steam, and then removed it.
While this type of surgery is a substantial improvement over previous techniques, especially when performed using robotic tools, there’s a risk of damaging sexual function, usually due to injury during the surgery.
There is also a risk of urinary strictures, a narrowing of the urethra due to trauma, with more-invasive procedures. There is, in fact, a version of the Optilume procedure designed to treat this problem as well.
The main question now is how long Optilume stays effective before the procedure needs to be repeated. There’s been little research into paclitaxel use for BPH; the focus has generally been on its use for treating prostate cancer.
Questions like when the prostate will begin growing again and what surgical options will be viable at that point, still need to be answered. There may be a point where removing some prostate tissue is simply a necessity, but researchers simply don’t know yet.
Nonetheless, Optilume has shown several strong benefits that make it worth asking about, including:
- It’s minimally invasive. Optilume doesn’t require surgery and doesn’t remove any tissue.
- It uses a well-understood medication. Paclitaxel has been on the market for decades and used in a variety of contexts, so its side effects and impacts are well understood.
- It preserves sexual function. There has been no documented impact on erections or ejaculation.
- It’s effective. As the PINNACLE study shows, the treatment works for at least a year. Further follow-up studies may find that it continues to work far beyond that period.
Similarly, medical research on treating benign prostate growth is moving quickly. If you’re concerned about possible sexual side effects from BPH surgery, the minimally invasive Optilume may provide symptom relief and preserve your sexual function while giving you time to see if better options become available.
Who Should Not Consider Optilume
According to the FDA, Optilume should not be used in people who have:
- Known hypersensitivity (allergy) to paclitaxel or related compounds
- An active urinary tract infection
- A penile prosthesis
- An artificial urinary sphincter
Take Control of Your BPH
No matter which option you choose, the key lesson here is that living with BPH symptoms isn’t inevitable as you age. There are a range of options to help reduce the impact of BPH, including the common symptom of erectile dysfunction. Cialis, for example, addresses both erectile dysfunction and BPH with one prescription, saving you both time and money.
To learn more about your options for ED and BPH, visit our erectile dysfunction page.
Dan is a long-time freelance writer focusing on technology, science, health, and medicine, with a lifelong interest in physics, biology, and medicine. His work has taken a particular focus on scientific studies “beyond the headlines,” reading the study to more closely examine the results.