FAQ - TULSA Procedure

Patient FAQ

Your health is important, and so is getting answers to the questions you have. We are here to give you the information that will help you make the right decisions for yourself.

All of these questions came from real patients and caregiver inquiries.

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PRE-OPERATION

Is this an inpatient or outpatient procedure?

TULSA Procedure is an outpatient procedure.

Following a TULSA Procedure, the patient is usually discharged from the clinic the same day, depending on the doctor’s assessment.

How long does the procedure take?

The TULSA Procedures is performed in a single session that takes a few hours (2-4 hours). It is conducted under anesthesia. After the procedure, the patient goes home the same day.

What is the success rate?

The TULSA-PRO® system has been studied in clinical trials. The positive results of the pivotal trial met all of its primary and secondary efficacy and safety endpoints. The clinical trial demonstrated that the TULSA-PRO® provides safe and effective prostate tissue ablation, with minimal adverse events, significant prostate volume and PSA reduction, and low rates of residual prostate disease. The favorable safety profile offered by the TULSA-PRO® contrasts with radical prostatectomy and radiation therapy that can leave many men with permanent erectile dysfunction, urinary incontinence and bowel dysfunction. For more information on the success rate, speak to your TULSA Procedure doctor.

For further information on success rates, you can read about the Clinical Study Results here

What are the risks, especially to sexual function? What are the chances of ED or retrograde ejaculation?

As with many procedures, there are side effects associated with the TULSA Procedure. The most common side effects include pain/discomfort in the procedure area, blood in urine, urinary tract infection, urinary incontinence, and erectile dysfunction. Your doctor will review with you all the risks associated with the TULSA Procedure.

How does TULSA compare to HIFU?

TULSA uses Directional High-Intensity Ultrasound delivered through the urethra. This means the energy is delivered directly through the urethra (which is being cooled throughout the procedure) to the edge of the prostate. The energy does not come through the rectum, leaving the rectum preserved. In addition, TULSA has rectal cooling throughout the procedure to further protect the rectum from any unintended heat.

HIFU uses High-Intensity Focused Ultrasound. This means the energy must pass through other tissue to reach the intended treatment location. The energy is directed through the rectum, meaning the rectal wall is exposed to direct heat. HIFU is typically guided by Ultrasound imaging, which doesn’t provide the anatomic detail of MRI or the real-time temperature feedback, which regulates the precision and predictability of the treatment.

For more information on the TULSA Procedure click here

INSURANCE & MEDICARE

What is the cost of the procedure?

The cost of the procedure is discussed with each individual TULSA Center.

To find a TULSA Center near you click here

Will Medicare/private insurance cover the procedure costs?

The patient will cover the cost of the procedure as a “cash pay model.” Medicare does not currently cover the procedure. Depending on individual insurance policies, there may be some reimbursement for the procedure, which should be further discussed with your policy provider.

CANDIDACY & HEALTH

How do I know if I am eligible for the TULSA Procedure?

Whether or not you will qualify for the TULSA Procedure will be decided by the treating physician.

Patients receiving the TULSA Procedure with the TULSA-PRO® system must be:

eligible for magnetic resonance imaging; screened by a Magnetic Resonance Imaging (MRI) professional (technologist or radiologist) before entering the MRI suite for the procedure
assessed by an anesthesiologist before the procedure

A treating physician will review your diagnosis and discuss if any further tests/procedures are required to confirm if the TULSA Procedure is a suitable option for you. In clinical trials, the patient population consisted of men with low and intermediate-risk, organ-confined prostate cancer.

HOW DOES THE TULSA PROCEDURE WORK?

What is the TULSA Procedure?

The TULSA Procedure uses the TULSA-PRO® system to transurethrally ablate prostate tissue by combining real-time Magnetic Resonance Imaging (“MRI”) with robotically-driven directional thermal ultrasound to deliver predictable physician-prescribed ablation of whole-gland or partial prostate tissue.

For more information on the TULSA Procedure click here.

Is the TULSA Procedure painful?

The TULSA Procedure is not painful, and if necessary, it’s manageable using over-the-counter pain medication.

What happens to the prostate after the procedure?

Following the TULSA Procedure, the prostate shrinks.

Clinical studies show a median perfused prostate volume decrease of 91%. The prostate tissue gets eliminated by getting absorbed by the body (healing) or microscopic particles in the urine.

During the TULSA Procedure, is the entire prostate destroyed?

The TULSA Procedure only ablates the physician-prescribed region, this can be whole-gland or partial prostate tissue. The amount of prostate ablated is up to the discretion of the treating physician and is fully customizable to the individual patients’ needs.

POST-OPERATIONAL

Is the procedure repeatable?

Yes, if needed, the TULSA Procedure is repeatable and does not exclude other common treatment options.

Will I require additional medications after the procedure?

Any post-procedure medication, including antibiotics, will be discussed with you by your physician.

When will I be able to have a glass of wine or beer?

This decision will be up to the discretion of the physician.

When do I know if it worked?

The physician’s assessment following the procedure will determine the success of the TULSA procedure.

What is my follow up?

Follow up of the TULSA procedure will be determined by the treating physician’s assessment.

Is there a chance the cancer could return at some point after procedure?

As with many procedures, yes, there is a possibility of re-occurrence. In the case of re-occurrence, TULSA Procedure is repeatable, and all other common treatment options are still available.

How long will I have to wear a catheter after my procedure, and what kind?

A catheter is typically in place for up to 14 days. Your physician will assess your voiding function to confirm the appropriate removal date.

What is the recovery time?

As observed during the pivotal study, patients typically returned to their daily activities (including work) within a couple of days following the procedure, and then back to baseline urinary/bowel quality of life within three months.

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