FAQ2

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Clinical Outcomes

Title

IN THE REZŪM PIVOTAL STUDY, WHAT PERCENTAGE OF PATIENTS WOULD HAVE REZŪM PERFORMED AGAIN IF THEIR SYMPTOMS WERE TO RECUR?

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

WHAT PERCENTAGE OF PATIENTS RECEIVED AN INTERVENTIONAL PROCEDURE WITHIN 4 YEARS POST-REZŪM?

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

IN THE REZŪM PIVOTAL STUDY, WHAT WAS THE WASHOUT PERIOD FOR THE EXCLUDED MEDICATIONS?

  • 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).

WAS THERE ANY IMPACT TO SEXUAL FUNCTION OR RETROGRADE EJACULATION SEEN IN STUDY PARTICIPANTS?

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.

HOW SHOULD CONSCIOUS SEDATION BE REPORTED IF USED IN THE PHYSICIAN OFFICE?

If conscious sedation is used in the physician office setting, an independent, trained observer must be present to monitor the patient’s status.

If the sedation is administered by the surgeon, it is reported using CPT codes 99152-99153. The intra-service time begins with the administration of the agent and concludes at the end of personal contact with the patient by the physician providing the sedation. Billing of these services requires continuous face-to-face attendance. Coverage and reimbursement for conscious sedation varies by the patient’s benefit plan and should be confirmed prior to the service.

 

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