Prostiva RF Ablation System

Implant Procedure & Techniques

The Prostiva® Radio Frequency System is designed specifically for the clinician office environment. This convenient option eliminates hospital scheduling and costs.

The average actual procedure is 20 minutes, with a total office time of approximately 90 minutes.

Patient Instructions

  • Discontinue all medications containing aspirin, ibuprofen, and vitamin E products 2 weeks prior to procedure.
  • Stop Coumadin® approximately 5 days prior to procedure with cardiologist's approval.
  • Decrease alcohol consumption, caffeine intake, and tobacco use 48 hours prior to procedure.
  • Consume NPO after midnight or eat only a light meal early the morning of procedure.
  • Take regular medications as necessary
  • Wear comfortable clothing day of procedure.
  • For your comfort, bring favorite CD to listen to during procedure.
  • Arrange for a ride home.

The Procedure

The following instructions give an overview of the procedure for the Prostiva RF Ablation System. These instructions are not intended to address all of the procedure options, complications, or special needs of patients; however, techniques that may reduce complications are recommended.

Before performing the procedure, please review the technical manuals and other educational information available through your Medtronic representative.

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1. Prepare the patient for the procedure 1. Prepare the patient for the procedure

  • Give the patient detailed instructions about the procedure.
  • Drape and catheterize the patient for purpose of emptying bladder and instilling liquid lidocaine.
  • Position and place the return electrode and cable.

> Return electrode placement instructions

2. Administer patient comfort control 2. Administer patient comfort control

  • Clinical trials demonstrate that the procedure can be performed without the need for general or regional (spinal) anesthesia.1-3
  • Most patients require only mild sedation, topical anesthesia, and/or prostate block. 1-3

> Comfort control examples

Medical practice is solely the responsibility of the individual clinician and not Medtronic.

3. Measure the prostate 3. Measure the prostate

  • Determine the distance from the verumontanum to bladder neck.
  • Perform transrectal ultrasound to determine the maximum transverse diameter.
  • Calculate prostate volume based on ultrasonic measurement.
  • Measure transverse width in axial orientation at level of the urethra from the TRUS.

4. Select the appropriate needle lengths 4. Select the appropriate needle lengths

  • Hand piece has six preset lengths ranging from 12 to 22 mm with 2 mm increments.
  • Needle shields automatically retract to protect the urethra.
  • Recommended guidelines based on clinical experience for needle settings.

The selection of the appropriate needle length is the clinician's sole medical judgment.

5. Determine the number of treatment planes 5. Determine the number of treatment planes

  • A treatment plane is created by delivering RF energy to the right and left lobes at the same level.
  • Guidelines are based on the distance from the bladder to the verumontanum (veru).

> Treatment plane guidelines

Determination of the number of treatment planes is the clinician's sole medical judgment.

6. Determine treatment locations for the median lobe if necessary 6. Determine treatment locations for the median lobe if necessary

  • Visualize the size and structure of the median lobe.
  • Needles should be deployed 1 cm away from the proximal margin of the bladder neck.
  • Select needle length. Length of 12 or 14 is recommended.

> Median lobe treatment locations

Determination of median lobe treatment locations and appropriate needle length is the clinician's sole medical judgment.

7. Create lesions 7. Create lesions

8. Post-procedure patient care 8. Post-procedure patient care

After the RF ablation procedure for symptomatic BPH, some patients are unable to urinate initially and need to be catheterized—2 to 3 days on average3. Forty-one percent of patients were catheterized in the original clinical study. In two later studies 6 and 15 percent of patients required catheterization.

Patients are able to return to normal activities in 1 to 2 days3. Most patients notice improvement within 2 to 6 weeks3,4. However, results may vary depending on the severity and duration of BPH symptoms, and size of the prostate treated. Maximum improvement may not be experienced for up to three months3,4.

RF ablation for BPH is associated with a low incidence of side effects and adverse events. For additional information, please see the complete Safety Data.

Additional Resources

Use this checklist before and after the RF ablation procedure.

Use this worksheet during the RF ablation procedure to record patient and lesion information.

References:

  1. Zlotta A, Giannakopoulos X, Maehlum O, Ostrem T, Schulman CC. Long-term evaluation of transurethral needle ablation of the prostate (TUNA) for treatment of symptomatic benign prostatic hyperplasia: clinical outcomes up to five years from three centers. Eur Urol. 2003;44(1):89-93. (In this study of 188 patients, 121 were evaluated 5 years after RF therapy. More than 75% did not need additional treatment for BPH stymptoms.)
  2. Khan et al., “An open study on the efficacy and safety of transurethral needle ablation of the prostate in treating symptomatic benign prostatic hyperplasia: the University of Florida experience,” J Urol, 1998; 160:1695-1700. p.1695.
  3. Parrott, EK. "TUNA of the Prostate in an Office Setting: Nursing Implications."Urologic Nursing. 2003; 23 (1):40.33-
  4. Naslund, MJ. Transurethral needle ablation of the prostate. Urology. 1997;50(2): 167-172.

Procedure Video

Watch video clips from the RF Ablation procedure:

This short video shows where to place the Return Electrode on the patient.

This procedure video shows MRI axial views of the prostate and setting prostate measurement.

This video shows Prostiva hand piece preparation.

This video shows how water is pushed into the urethra.