Prolieve Thermodilatation^® System

Patient Information

01) What are the treatment options for benign prostatic hyperplasia (BPH) also known as enlarged prostate?

Your doctor has several ways to treat enlarged prostate. Your decision about which treatment is best for you will depend upon your diagnosis, overall health, goals for treatment, and the treatment options available. Reviewing the following treatment options may help you determine which features of treatment are most important to you. An exercise in the following section will help you further evaluate the various features of treatment so that you can make an informed decision with your doctor. Treatments available for enlarged prostate include:

Watchful Waiting - As the name suggests, this involves paying attention to your symptoms and visiting your doctor if they worsen or lead to other urinary tract problems. This is an option if you have mild symptoms or are not bothered by your symptoms.

Medications—Drugs might be an option if you have moderate or severe symptoms, your prostate gland is the right size to respond to this treatment, and you are not already taking other medications that could create a health risk when combined with prostate medications (for example, taking sildenafil for erectile dysfunction). While prostate medications or combinations of drugs usually provide some relief, they may require several weeks to 6 months to take effect. They also may have side effects, and the long-term effectiveness of medications can be limited.
- Alpha-blockers are a class of drugs used to relax the muscles of the prostate.
- 5 alpha-reductase inhibitors are a class of drugs used to shrink the prostate.
The Prolieve Thermodilatation System Treatment—This less invasive treatment is an option if you have moderate or severe symptoms and your prostate gland is the right size to respond to this treatment. The treatment is performed in your doctor’s office and requires no general anesthesia or incisions. Requiring only a local anesthetic gel, this 45-minute treatment is designed to relieve pressure on the prostatic urethra, resulting in an improvement in urine flow. During the procedure, a balloon attached to a catheter opens up the prostatic urethra while microwave heat reduces the enlarged tissue of your prostate. In the clinical trial for Prolieve, the majority of men left without a catheter and experience few post-treatment complications or sexual side effects during the clinical trials.

Other Transurethral Office-Based Procedures—These treatments are generally options for men with moderate to severe symptoms. These treatments provide moderate to large relief, but they may affect sexual function and generally require sedation or general anesthesia for pain management. A patient’s ability to tolerate treatment and a doctor’s skill at performing the procedure can also affect the outcome of these procedures. Patients are generally required to wear a catheter following treatment.
- Transurethral Microwave Heat Treatments-A small catheter is inserted through the urethra to reduce the amount of enlarged prostate tissue with microwave energy.
- Transurethral Needle Ablation-A small needle is attached to the end of a rigid catheter. The needle is heated to reduce prostate tissue.
Surgery—Several surgical options are available if you have moderate or severe enlarged prostate along with other urinary conditions or when other treatments have not worked well. Generally, these involve removing the inner portion of the prostate gland and usually result in large improvement of symptoms. Ask your doctor about the risks involved with each procedure.
- Transurethral Resection of the Prostate (TURP)-This is the most common form of surgery. Patients are hospitalized during the procedure and may remain hospitalized for several days. Patients must wear a catheter for up to several weeks following surgery.
- Holmium Laser Therapy-A surgical alternative to TURP, holmium laser therapy uses laser energy to relieve enlarged prostate symptoms and is designed to reduce traditional complications associated with TURPs. With holmium laser therapy, patients experience minimal pain after the operation and spend less time in the hospital than with TURP. They are also able to resume normal activities within a week. There are few to no sexual side effects with holmium laser therapy, and, unlike TURP, it can be performed on patients taking anticoagulant medications like Coumadin® (warfarin sodium).

02) What do I need to know about the Prolieve™ Thermodilatation System?

For complete information, please read the Prolieve System Patient Information Booklet provided to you by your physician.

The Prolieve Thermodilatation System Treatment—This less invasive treatment is an option if you have moderate or severe symptoms. The treatment is performed in your doctor’s office and requires no general anesthesia or incisions. Requiring only a local anesthetic gel, this 45-minute treatment is designed to relieve pressure on the prostatic urethra, resulting in an improvement in urine flow. During the procedure, a balloon attached to a catheter opens up the prostatic urethra while microwave heat reduces the enlarged tissue of your prostate. The majority of men left without a catheter and experienced few post treatment complications or sexual side effects during the clinical trials.

03) How does the Prolieve Thermodilatation System operate?

The physician will insert a catheter into your urethra. When microwave heat is turned on, it will be transmitted from a special antenna inside the catheter to provide continuous heat to your prostate. The heat will reduce the enlarged tissue of your prostate. A small balloon that is also part of the catheter will inflate within the section of the urethra where the prostate is located. The inflated balloon will cause the tissue to expand. During the entire 45-minute treatment, water will be circulating inside the catheter. For your safety, the Prolieve System’s computer monitors the temperature surrounding the treatment area by means of a rectal temperature monitor.

The Prolieve System is FDA approved. The Prolieve System’s design and operating protocol were investigated in clinical studies of other men suffering from BPH. The results showed the Prolieve System is safe and effective.

04) How do I know if the Prolieve Thermodilatation System is right for me?

First, the physician will evaluate you to see if you are a candidate for this therapy. The following is a list of tests your physician may order: urine analysis, urine culture, blood tests, uroflowmetry, ultrasound, and cystourethroscopy. Your physician will choose which tests you may have. Only your doctor can decide if the Prolieve Thermodilation System is right for you.

05) What will take place during the procedure?

On the day of your procedure, you will come to the treatment center. You should bring someone to drive you home since this is an outpatient procedure. Each physician's office is different. Therefore, treatment procedures may vary a bit. In general, here is a recap of the steps of the treatment you can expect:

1. At least one hour before treatment, your physician may give you medication to help you relax during the procedure. Other medications that your physician may give you are to help avoid infections.
2. You will be asked to empty your bladder.
3. You will be asked to lie on your back on the treatment bed. Your physician will then apply anesthesia to the tip of your penis. This will help you to not feel pain while the catheter is inserted through your urethra.
4. To keep you warm and comfortable, you will remain covered throughout the procedure.
5. During the treatment, you may be offered a book, or earphones to listen to music.
6. Before your physician inserts the catheter, K-Y® Jelly lubrication will be applied with a large syringe, without a needle, directly into the urethra.
7. Your physician will then insert the catheter through the urethra into the bladder. This is done in the same manner as inserting a regular catheter.
8. Your physician will double check that the catheter is in place. This may be done by ultrasound. When the catheter is in place, your physician will secure it so that it does not move. When the balloon of the catheter is inflated, you may feel slight pain or discomfort. This is normal. It is also possible that during treatment you may experience bleeding, or some discomfort such as bladder spasms, feeling the need to empty your bladder or have a bowel movement. You will feel a warming sensation as the temperature increases during treatment. This is normal. There is water circulating through the catheter.
9. Next your physician will prepare the rectal temperature monitor for insertion.
   a. Your physician will place a sterile cover on the monitor.
   b. The surface of the cover on the monitor will be lubricated with K-Y Jelly.
10. Your physician will then insert the rectal monitor and secure it so that it does not shift position. During the treatment, the rectal monitor will be checked frequently to ensure proper positioning.

Treatment will then be initiated. It will last approximately 45 minutes. Your physician will monitor you at all times. If you experience severe pain, please inform your physician right away.

06) Will I have any discomfort or problems during the procedure?

When the balloon of the catheter is inflated you may feel slight discomfort. Also during the procedure you may experience:

• Bladder spasms, which will feel like you need to empty your bladder or have a bowel movement
• A warming sensation as the temperature increases during treatment
• Blood in your urine

07) Will I have any discomfort or problems after the procedure?

You will be able to go home right after treatment. You should have someone drive you home after the procedure.

In the Clinical Trial for the Prolieve™ Thermodilatation System leave the doctor’s office without a catheter. However, there is a chance you may need a catheter. There is no need for concern. The catheter will let the urine drain from your bladder while the swelling, if any, goes down. In most cases the catheter will need to remain for three days or less. Please follow your physician's instructions carefully.

Some patients have experienced side effects following treatment. The most common side effects are:

• Bladder spasm
• Pain
• Soreness
• Blood in the urine

These side effects cleared within a few days. Other side effects reported were urinary frequency, urgency and urinary retention. These were most likely symptoms of BPH and not caused by the treatment.

Remember you are unique and you may experience other symptoms. Please notify your physician if you experience bladder spasms, pain, soreness, or blood in your urine or if you have any other concerns about how you are feeling. As with any transurethral microwave therapy procedure, there are rare cases of serious side effects. Please consult with your physician.

08) What should I expect once I have undergone the Prolieve Thermodilatation System?

• Quality of life has been shown to improve .
• The side effects reported have been few.
• It is a single 45-minute treatment that is performed at your physician's office.
• It reduces the need for multiple-office visits for BPH medications and the related costs and inconvenience.
• It is not a surgical procedure.

09) Frequently Asked Questions

Is BPH a type of cancer?
No, BPH is not a type of cancer.

Who is a good candidate for treatment with the Prolieve System?
Men with moderate to severe BPH symptoms. Your doctor can discuss with you whether the Prolieve System Treatment is right for you.

Will I continue to need to take my BPH medications after the Prolieve System Treatment?
As with any medication ask your doctor what regimen is appropriate for you. However, most patients are able to discontinue taking their BPH medications within a few weeks after the treatment.

Will the Prolieve System Treatment affect my sexual function?
99% of patients treated with the Prolieve Thermodilatation System in the clinical trial did NOT experience any form of erectile dysfunction following the treatment.

How soon will my symptoms improve?
All patients are different and the response to medical treatments will vary. However, many patients report noticeable BPH symptom improvement shortly after the treatment. Many patients showed improvement in their AUA symptom scores within 2 weeks of their Prolieve Thermodilatation System Treatment. Ask your doctor about his experience using the Prolieve Thermodilatation System.

Is the Prolieve System Treatment covered by Medicare?
Yes

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INDICATIONS

The Prolieve Thermodilatation System is a transurethral microwave therapy device for the treatment of symptomatic Benign Prostate Hyperplasia (BPH) in men with a prostate size of 20 to 80 grams and prostatic urethra length between 1.2 cm and 5.5 cm and in whom drug therapy (finasteride or Proscar®) is typically indicated.

CONTRAINDICATIONS

Patients who have significantly decreased pain responses, severe urethral stricture prohibiting catheterization, current urinary or prostatic infection, penile or urinary sphincter implants, prostate sizes <20 g or >80 g, peripheral arterial disease with intermittent claudication or Leriche's Syndrome, protruding median lobe with obstruction, metallic implants, implanted cardiac pacemakers or defibrillators, previous transurethral prostatectomy, renal impairment, coagulation disorders, neurological disorders that may affect bladder function, bladder stones, evidence of prostate or bladder cancer or have an interest in the preservation of future fertility.

WARNINGS AND PRECAUTIONS

All components of the Prolieve System must be used in accordance with the User Manual. The emission of microwave energy must be off during placement and removal of the catheter. Patient comments of pain or excess heat should be investigated. Failure to monitor adequately and deliver the procedure per User Manual may lead to decreased patient safety and/or reduced clinical effectiveness. A single high dose of microwave radiation to the testes, or testicular heating for a prolonged period, may result in temporary or permanent sterility. No anesthetic other than aqueous-based topical intraurethral anesthetic used for catheter placement is recommended. The safety and effectiveness of the Prolieve System for men <50 and >80 years old has not been established in clinical studies. If procedure kit seal or internal sterile packaging seals are damaged or broken, the contents may not be sterile and could cause infection.

POTENTIAL ADVERSE EFFECTS

Potential adverse effects that may occur include but are not limited to bleeding, bowel irritation, urethral injury (irritation), chronic pain at site, bladder spasms, urinary retention (complete or incomplete), urinary incontinence, prostatitis, pressure sensation, urinary urgency, urinary tract infection, urethral tear, anal irritation, urethral stricture, infertility, retrograde ejaculation and erectile dysfunction.

CAUTION:

Federal (USA) law restricts this device to sale by or on the order of a physician.

Coumadin is a trademark of Bristol-Myers Squibb Pharma Company. K-Y is a trademark of Johnson & Johnson Corporation. Proscar is a trademark of Merck & Co., Inc. Copyright © 2004 by Boston Scientific Corporation or its affiliates. All rights reserved.