Enlarged Prostate Medication

No, BPH (Benign Prostatic Hyperplasia) is a benign condition and unrelated to prostate cancer; however, it can greatly affect a man’s quality of life. BPH is NOT a type of cancer.

If left untreated, BPH can lead to permanent bladder damage.¹ When the bladder does not empty completely, the risk of developing urinary tract infections (UTIs) may increase.² Other serious problems can also develop over time, including bladder stones, blood in the urine, incontinence, or urinary retention.²

You may want to seek BPH treatment if you experience BPH symptoms such as urgent need to urinate, difficulty starting your urine stream, need to push or strain when urinating, dribbling, the sensation that the bladder is not empty after urinating, weak urine flow, increased frequency of urination, frequent night time urination, burning or pain during urination.³

You may be a good candidate if you are a male, 50 years of age or older, and have symptoms relating to BPH. Speak with your urologist to see if the PUL treatment is right for you. If you have a known allergy to nickel, titanium or stainless steel, talk to your doctor about your allergy before getting a PUL treatment.

The PUL treatment is a proven, minimally invasive approach for treating lower urinary tract symptoms due to benign prostatic hyperplasia (BPH) that can get men off BPH medications and avoid major surgery. The PUL permanent implants, delivered during a minimally invasive outpatient procedure, relieve prostate obstruction and open the urethra directly without cutting, heating, or removing prostate tissue.

As with any medical procedure, individual results may vary. Speak with your urologist to see if the PUL treatment is right for you. Most common side effects are mild to moderate and include pain or burning with urination, blood in the urine, pelvic pain, urgent need to urinate and/or the inability to control the urge. Most symptoms resolve within two to four weeks after the procedure.

The PUL consists of a delivery device and tiny permanent implants.

• The PUL Delivery Device is placed through the obstructed urethra.
• Small PUL Implants are placed to lift or hold the enlarged prostate tissue out of the way. The Implants are delivered through a small needle that comes out of the delivery device and into the prostate.
• The PUL Delivery Device is removed, leaving an open urethra that provides symptom relief.

The implants are intended to be permanent. The implant is made up of standard surgical implantable materials: a nitinol capsular tab, a stainless-steel urethral tab, and polyethylene suture that holds the two tabs together. Your doctor can remove the urethral implant, if needed. The suture can be cut and the urethral endpiece can be retrieved with a standard grasper. The capsular tab will remain in place inside the body.

A urologist, a doctor who specializes in the treatment of urinary and genital tract disorders, uses the PUL System to treat urinary symptoms due to BPH. The urologist undergoes extensive training before using the PUL System.

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The PUL Delivery Device is a single-use, sterile medical device that contains one PUL Implant. Patients typically require 4-6 implants during a PUL treatment. The Delivery Device is inserted transurethrally through a rigid sheath under cystoscopic visualization in order to reach the targeted area of obstruction.

The PUL Implants are small permanent implants that hold the obstructing prostatic lobes apart. They are deployed through a needle that comes out of the delivery device.  Each implant is made with common implantable materials: nitinol, stainless steel, and suture.  Typically, 4-6 implants are placed into the prostate.

The examination performed will be determined by your physician. The physician will likely ask you to fill out a questionnaire to assess your symptoms, otherwise known as IPSS (International Prostate Symptom Score). Additionally, some of the common examinations include Digital Rectal Exam (DRE), Transrectal Ultrasonography (TRUS), Bladder Ultrasound, and Urinalysis.

If you and your doctor decide that the PUL treatment is right for you, your doctor will provide you with more detailed information relating to the treatment. Your doctor will use the PUL Delivery Device to deploy permanent implants to relieve obstruction caused by the enlarged prostate that is pressing on your urethra. The procedure is minimally invasive and usually takes less than an hour, performed under general anaesthesia. Typically, no catheter and no overnight stay is required post-treatment.⁴ Your doctor will discuss with you the procedure and length of stay.

After the treatment, patients typically go home the same day without a catheter. There is minimal downtime post-treatment and many patients experience symptom relief as early as 2 weeks. Patients may experience some urinary discomfort during the recovery period. The most common side effects may include blood in the urine, some pain or discomfort when urinating, some increased urge to urinate and discomfort in the pelvis. These typically resolve within two to four weeks after the procedure.

The implant is made up of standard surgical implantable materials: a nitinol tab, a stainless-steel tab and polyester suture that holds the two tabs together. Your doctor can remove the urethral implant, if needed.

Clinical studies have shown the PUL treatment does not cause new, sustained instances of erectile or ejaculatory dysfunction.⁴ The same cannot always be said of other BPH therapies such as TURP, laser and even medication.

Non-clinical testing has demonstrated that the PUL Implant is MR Conditional. A patient with this device can be safely scanned in an MR system immediately after placement meeting the following conditions:

• Static magnetic field of 3.0 Tesla or less
• Maximum spatial field gradient of 1,500 Gauss/cm (15 T/m) (extrapolated)
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4 W/kg for 15 minutes of continuous scanning (i.e., per pulse sequence) (First Level Controlled Operating Mode)

Under the scan conditions defined above, the PUL Implant is expected to produce a maximum temperature rise of 2.4°C after 15 minutes of continuous scanning (i.e., per pulse sequence)

In non-clinical testing, the image artifact caused by the device extends approximately 15 mm from the PUL Implant when imaged with a gradient echo pulse sequence and a 3.0 Tesla MRI system.

The safety of the delivery system has not been evaluated in the MR environment, and therefore, the delivery system should not be used within the MR environment.

Patient implant cards are provided to inform the patient that the PUL implant is MR Conditional and can safely be scanned only under specific MR conditions.

If you have any questions about MRI safety, please consult your doctor.

The implants are not expected to interfere with a DRE. The implants are placed on the anterior (front) side of the prostate, and a DRE is conducted on the posterior (back) side of the prostate.

PUL is covered by Private Health Insurers. Check with your urologist and your insurance provider for your specific coverage details.

The PUL treatment has been found to be a safe and effective treatment for symptoms related to BPH. Its risk profile is better than most traditional surgical options, and patients report symptom relief better than reported with medications.⁴ In the large, pivotal study on the PUL, there were no instances of new, sustained erectile dysfunction or ejaculatory dysfunction.⁴

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We have over 25 peer-reviewed publications demonstrating the PUL is safe and effective. Improvement in urinary symptoms, as seen through reduction in IPSS (International Prostate Symptom Score), has been consistent across the various studies, showing rapid relief in as early as two weeks and sustained effect to five years.⁵

In our clinical studies, the most common side effects reported were mild to moderate and include pain or burning with urination, blood in the urine, pelvic pain, urgent need to urinate and/or the inability to control the urge. Most symptoms resolved within two to four weeks after the procedure.⁴