Prostate Frequently Asked Questions | TULSA Procedure

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Pre-operation

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.

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.

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.

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.

The TULSA Procedure 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, the TULSA Procedure 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 difference between the TULSA Procedure and HIFU, click here

Candidacy and health

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?

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.

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

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.

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

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

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

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

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

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

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