FAQ

Patients were asked at their 3-month follow-up visit whether they would consider having the Rezūm procedure again if their symptoms were to recur. 120/134 (90%) are likely to have the treatment again if their symptoms recurred after 5 years.¹

Through 4 years, 6 of 135 (4.4%) patients underwent a secondary treatment for continued lower urinary tract symptoms. One patient had an undiagnosed/untreated intravesical protrusion, and as a result, had an open simple prostatectomy at 1 month, three patients had a plasma button transurethral vaporization of the prostate, and two were retreated with Rezūm. Four of the 6 patients who went on to a secondary treatment had an identified but untreated median lobe.²

• Antihistamines – 1 week prior to procedure unless there is documented evidence of stable dosing for last 6 months (no dose changes).¹
• Alpha blockers – 4 weeks prior to procedure.¹
• Type II, 5-alpha reductase inhibitor (e.g., finasteride (Proscar, Propecia) – 3 months prior to procedure.¹
• Dual 5-alpha reductase inhibitor (e.g., dutasteride (Avodart)) – 6 months prior to procedure.¹
• Estrogen, drug-producing androgen suppression, or anabolic steroids – 3 months prior to procedure.¹
• Daily dose PD5 Inhibitors (e.g.Viagra, Levitra or Cialis) – 4 weeks prior to procedure.¹
  

All patients had to remain off the excluded medications until the end of the Rezūm II Study (5 years post-procedure).

Study results show that Rezūm has a positive safety profile with preservation of sexual function, and no late-occurring related adverse events or de novo erectile dysfunction reported at 4 years.

During the Rezūm Pivotal Study, antiplatelet or anticoagulant medication had a 10 day pre- and post-procedure washout. There has been no data collected regarding this subset of patients and therefore, we recommend you follow your standard of care for minimally invasive procedures.

Dr. Lennart Wagrell’s standard of care for treating patients on anti-coagulants varied depending on the medication:

• Plavix – 7 day pre procedure washout
• Warfarin – 3 day pre procedure washout

All patients were able to resume their anti-coagulants immediately post procedure.

It is recommended that you follow your current protocol for treating patients on BPH medication with other minimally invasive procedures.

During the Rezūm Pivotal Study, all patients were washed out of their BPH medication to ensure the efficacy seen was from Rezūm alone. There has been no data collected on using Rezūm simultaneously with BPH medications and therefore, we recommend you follow your standard of care.¹

81% of urinary retention patients were able to void after an average of 28 days post-Rezūm.^3,4

The flow rate of the steam is slightly above interstitial pressure

Water vapor energy is a more efficient form of energy. Unlike other treatments where a larger amount of energy is needed to conductively destroy cells using a heat gradient or vaporization, water vapor energy uniformly and instantaneously denatures cells, rendering them non-viable. This allows the body to then naturally resorb the treated tissue.

Labeling states 500-5000 mL of isotonic 0.9% sterile saline, hard or soft bottles should be used

Rectal temperature monitoring was done in 25 subjects in the Rezūm Pilot Study. Rectal Temperatures remained constant during the course of treatment for all 25 subjects. The mean rectal temperature observed was 37.03° C. No adverse events associated with rectal injury were observed among any of the 25 subjects.¹

The urethral temperature was not measured during the clinical studies. To keep the urethra and shaft of the device cool, there is a constant flow of room temperature (20–25° C) saline flush when the needle is deployed. The system also sends a small burst of saline flush through the device every 30 seconds during navigation and idle to ensure the shaft is cool while in use.

Since Rezūm does not take out the entire transition zone, the blood vessels outside of the lesion, that run up to the treated tissue, are able to carry lymphocytes to the treated area. These lymphocytes engulf, enzymatically digest and break down the lesion which is then carried back through the blood stream where the body eliminates it. This process continues until the entire lesion is resorbed, moving from the outside of the lesion toward the inside.

If the needle is placed too shallow and vapor reaches the urothelium, this tissue could potentially be devascularized and resorbed, resulting in asymmetrical healing or a divot in the area. Vapor that escapes into the prostatic urethra condenses immediately as it mixes with the room temperature saline flush (20–25° C) minimizing urethral impact.