|
|
| Microwave Therapy™ for Enlarged Prostate |
| Why Choose Microwave Therapy? |
Microwave Therapy solves the problem of an enlarged prostate without the need for drugs, needles, anesthesia or a hospital stay. The single non-surgical treatment can be performed in the comfort of your urologist's office. More than 100,000 patients worldwide have been treated with the Microwave Therapy procedure.
A few years ago the only way to treat enlarged prostate was with a lifetime regimen of drugs or major surgery. While these treatments can be successful, they both have disadvantages.
|
 |
Drug Therapy
Several medications are available to treat the symptoms of an enlarged prostate and can be an effective choice for many men. However, drugs may not always work, and side effects include impotence, headache, dizziness, and fatigue. The medication must be taken daily for life and over time, the cost can become a large expense.
|
|
Surgery
Surgery is typically very successful in treating an enlarged prostate. However, it carries the risks associated with anesthesia and recovery time can be lengthy. Surgery does involve additional risks, including the possibility of postoperative pain, discomfort and bleeding, urinary incontinence, retrograde ejaculation, and impotence.
|
| Clinical studies show that Microwave Therapy produces significant relief without the risks associated with more invasive surgery or the side effects that drug therapy can cause. Microwave Therapy does not require hospitalization, anesthesia or the long recovery time some surgical patients must face. Microwave Therapy has been shown to be more cost effective than other treatments, costing a fraction of the thousands of dollars some patients spend on a lifetime of drug therapy. Medicare and many other insurance carriers cover the procedure. |
| How Microwave Therapy Works |
| The treatment uses a specially designed antenna inside a catheter that directs heat deep into the prostate to safely destroy enlarged tissue. At the same time cool water is circulated inside the catheter to protect the urethra from the heat generated by the microwave energy. The result of the treatment is shrinkage of the prostate to relieve pressure on the urethra to reduce your BPH symptoms. |
| What to Expect Before Microwave Therapy |
|
You'll need to have a physical examination with a urologist trained in performing the treatment. He will explain the treatment to you in detail and answer any questions you may have. |
|
Your urologist will provide specific pretreatment instructions such as reducing fluid intake or modifying your diet the day of treatment. |
| What to Expect During the Treatment |
|
Microwave Therapy is performed in the urologist's office. You will be awake during the entire procedure. The treatment itself generally takes between 30 minutes to an hour although you should allow 2 to 3 hours for the entire office visit. |
|
You'll be positioned on a treatment bed in a comfortable position. You may be able to watch television, read a book, or listen to music while the treatment is being done. While you may experience some discomfort during the procedure, the staff will do their best to make you as comfortable as possible. You may be given medication to help you relax before beginning the treatment. |
|
To start the procedure, your urologist will insert a flexible catheter into your urethra and position it in the prostate. A soft balloon catheter will then be placed in your rectum to monitor rectal temperatures during the procedure. |
|
Once the treatment begins you may experience some discomfort such as:
- Bladder spasms
- The sensation of having to empty your bladder
- The sensation of needing to have a bowel movement
- A warm or burning sensation in your abdomen
- A burning sensation at the end of the penis
- Pressure in the rectum
|
|
The technologist and urologist will make you as comfortable as possible during the procedure |
| What to Expect After the Treatment |
|
Arrange in advance for someone to drive you home after the treatment. You may not drive if you receive narcotics. |
|
Because the tissue surrounding the urethra may be irritated after the treatment, you may go home with a urinary catheter in place. This allows urine to drain from your bladder while the swelling and inflammation goes away. Generally, the catheter is in place for 2 to 5 days. |
|
You may notice a pinkish discharge in your urine or around the catheter - this is normal. |
|
Some men are uncomfortable for a few days to weeks after the procedure and may experience a few side effects from the treatment such as:- Soreness in the lower abdomen
- Urgency even after the catheter is removed
- Frequent urination
|
| How the Healing Process Works |
|
You may notice no change in your BPH symptoms immediately after the treatment. However, your body is actively working to heal itself. In the 6 to 12 weeks after treatment, your body will gradually reabsorb the tissue treated with Microwave Therapy, and your enlarged prostate will get smaller. As your prostate shrinks, the pressure on your urethra decreases and your BPH symptoms will be reduced. The shrinkage may continue for several months. |
|
Most men start to see improvement in symptoms in 6 to 12 weeks, although this varies with the individual. |
| Microwave Therapy has worked for thousands of men and it may be right for you. Be sure to discuss any questions or concerns with your urologist. |
Next-Generation, Dual-Action Thermodilatation, Minimally Invasive Therapy for BPH Symptoms
The Prolieve Thermodilatation® System is the next generation in minimally invasive BPH symptom treatment. This dual-action thermodilatation technology simultaneously heats the prostate while dilating the urethra. The treatment is well tolerated by patients and most patients generally do not require post-treatment catheterization.
The Prolieve® System is made up of a microwave, computer, and a single-use Prolieve System Procedure Kit. The device delivers microwave energy (heat) to the prostate for the treatment of symptomatic BPH in men with a prostate size of 20 to 80 grams, a prostatic urethra length between 1.2 cm and 5.5 cm and in whom drug therapy (e.g., Proscar® [Finasteride]) is typically used. The device uses a microwave antenna that is inside a transurethral catheter, which is placed inside the urethra to heat the prostate. At the same time, a balloon on the catheter inflates and pushes against the wall of the urethra. A heat-exchanger cartridge is responsible for warming fluid that circulates through the balloon catheter. A rectal temperature monitor is placed in the rectum near the prostate to monitor temperature. The heating process is controlled by a computer in the machine that reads the temperature measured by the rectal temperature monitor.
Procedure
The physician and the technician prepare the Prolieve System for use according to the instructions in the Prolieve System User Manual. A topical aqueous-based anesthetic will be applied to the opening of the urethra, a catheter will be inserted into the bladder and different methods, such as x-ray or ultrasound, may be used to verify the exact location of the equipment. A temperature monitor with a prophylactic cover will be inserted to monitor the treatment. Heat generated by microwave power and compression by the transurethral catheter balloon will be applied to the prostate gland. The catheter and temperature monitor will be removed at the conclusion of the treatment. The preparation and the procedure should take approximately 60 to 90 minutes.
Image Descriptions
Figure 1:
This is a schematic illustration of a cross section of a prostate BEFORE treatment with The Prolieve Thermodilatation System.
Figure 2:
This is a schematic illustration of the proper internal position of The Prolieve Thermodilatation System balloon catheter in the prostate.
Figure 3:
This is a schematic illustration of a cross section of a prostate immediately AFTER treatment with The Prolieve Thermodilatation System. |
Indications:
The Prolieve™ Thermodilatation System is a transurethral microwave therapy device that provides a non-surgical, minimally invasive procedure for the treatment of symptomatic Benign Prostatic Hyperplasia (BPH) in men with a prostate size of 20 to 80 grams, a prostatic urethra length between 1.2 cm and 5.5 cm and in whom drug therapy (e.g., Proscar® [Finasteride]) is typically indicated.
Contraindications:
Patients whose pain response has been significantly decreased by any means (previous surgery, regional or local anesthetic, or other relevant condition which is determined by the physician upon evaluation) because the patients' ability to detect pain is a treatment safety mechanism.
Severe urethral stricture preventing catheterization.
Current urinary or prostatic infection.
Presence of a penile or urinary sphincter implant.
Prostate size <20g or >80g.
Peripheral arterial disease with intermittent claudication or Leriches Syndrome (i.e., claudication of the buttocks or perineum).
Protruding median lobe resulting in a "ball-valve" type of obstruction at the bladder neck.
Evidence of prostatic cancer or bladder cancer.
Presence of metallic implants, e.g., pelvic, femur, penile prosthesis, etc.
Presence of implanted cardiac pacemakers, or defibrillators.
Previous transurethral prostatectomy.
Patients interested in the preservation of future fertility.
Patients with a previous history of pelvic radiation.
Patients with coagulation disorders.
Patients with renal impairment.
Patients with neurological disorders that might affect bladder function.
Patients with bladder stones and large post voiding residual (greater than 250 mL).
Warnings: Patient Safety
The physician must monitor patient condition during the treatment. Patient comments regarding pain or excess heat in regions not associated with the expected treatment location should be fully investigated. Failure to monitor adequately and deliver the procedure per recommendations of the labeling may lead to serious patient injury.
There are unlikely but serious thermal (heat-related) injuries that may occur which include fistula formation and tissue damage to the penis or urethra, requiring urostomies, partial amputation of the penis, and/or other therapeutic interventions, and narrowing of the penile urinary tube at any time after the treatment.
The physician must ensure the careful and correct placement of the catheter and temperature monitor as shown in the User Manual before heating commences. The recommended procedures for catheter and temperature monitor placement will minimize the probability of excessive temperature in normal tissue and non-therapeutic temperature in the treated area.
The physician must adhere to the recommended applicator placement and sterile field preparation to reduce the likelihood of surface burns and blistering from the subsequent delivery of therapeutic heat.
The emission of microwave energy must be off during placement and removal of the catheter to avoid stray microwave radiation directed towards the eyes (or testes) of the patient or the operator.
A single high dose of microwave radiation to the testes, or testicular heating for a prolonged period, may result in temporary or permanent sterility. Elevated temperatures may be expected to affect the pharmacological activity of some drugs, with unpredictable results. Altered vascular perfusion may dramatically affect the local tissue effects of systemic or infused drugs.
Potential Adverse Effects:
Microwave heating devices and dilatation have the potential for producing adverse events as a result of the delivery of therapeutic heat, or of the exposure to electromagnetic radiation. Those adverse events not seen in the clinical trials include: urethral stricture, pelvic abscess, allergic reaction including anaphylaxis, bladder neck contracture, urethral tear, rectal wall injury, infertility, and fistula.
|
Treatment-Related Precautions:
The safety and effectiveness of The Prolieve System for men <50 and >80 years old has not been established in clinical studies.
The use of The Prolieve System must be prescribed and administered under the direct supervision of a qualified and trained physician following appropriate urological evaluation of the patient.
No anesthetic other than aqueous-based topical intraurethral anesthetic used for catheter placement is recommended.
The user must comply with strict adherence to aseptic techniques during the placement of applicators to avoid localized infections. If the Procedure Kit seal or internal sterile packaging seals are damaged or broken, the contents may not be sterile and could cause infection. Damaged or broken seal devices should be discarded or returned.
Treatment with The Prolieve System applies compression and deposits microwave energy, which converts to heat within the patient's prostate and in the immediately adjacent tissue. Some animal studies in the literature suggest there may be unknown health effects from exposure to microwave radiation, including an increased incidence of tumors. Although it is not possible to extrapolate these studies to humans, they suggest that unnecessary microwave radiation exposure should be avoided.
Device-Related Precautions:
Failure to use all the components of The Prolieve System with temperature sensors in accordance with the User Manual may result in insufficient therapy and/or increased risk of injury or infection to the patient.
Any nearby equipment operating on a similar frequency to that of The Prolieve System should be operated at a distance of at least 2 meters (6.5 ft.) (including locations behind adjacent walls) to avoid device-to-device interference. Such devices include but are not limited to cell phones and/or other sensitive treatment and monitoring equipment (e.g., drug infusion devices, physiological devices.)
The Prolieve System is designed to operate in a room with adequate space for the patient, treatment bed, permanent instrument, with adequate lighting, and clinical personnel. The treatment room should also be clean and support the needs of the physician to treat in a sterile field. Failure to provide these may have a deleterious effect on the patient and/or treatment result.
Any modifications made to equipment or software without explicit approval from the manufacturer poses a potential safety threat to the operators and patients. Only qualified, trained personnel should be allowed to operate the equipment. Please consult the User Manual for specific technical warnings and precautions on device operation.
References
1. Prolieve is a trademark of Celsion Corporation
2. Proscar is a trademark of Merck & Company, Inc. |
 Prostatron Cooled ThermoTherapy is a non-surgical minimally invasive treatment used to treat BPH in a single, 30 - 60 minute session. The Prostatron System uses precisely targeted microwave energy to heat and shrink enlarged prostate tissue while cooling mechanisms protect healthy, surrounding tissue. The treatment is performed on an outpatient basis and requires only local anesthesia. Within weeks, most patients notice improvements in symptoms and quality of life. Ask your urologist if Prostatron treatment is right for you.
Available in Europe since 1991, the Prostatron System is one of two Cooled ThermoTherapy products based on microwave technology and marketed by Urologix for treating enlarged prostate. Prostatron was released to the United States in May 1996 after the U.S. Food and Drug Administration (FDA) approved it for the treatment of patients with BPH. The Targis System was introduced in the U.S. in 1997. More than 100,000 patients worldwide have been treated with the Prostatron and Targis Systems.
|
|
|
|
