Results of a 5-year multicenter trial of a new generation cooled high energy transurethral microwave thermal therapy catheter for benign prostatic hyperplasia.

Published

Journal Article

PURPOSE: We determined the safety, effectiveness and 5-year durability of the new generation, cooled, high energy microwave treatment Cooled ThermoCath® catheter with the Targis® cooled high energy transurethral microwave thermal therapy system by performing a prospective, multicenter trial in men with lower urinary tract symptoms and clinical benign prostatic hyperplasia. MATERIALS AND METHODS: At 5 American centers a total of 66 men were treated with the catheter at a 28.5-minute session. Patients were taught self-catheterization after treatment. They returned after 1 and 6 weeks, 3 and 6 months, and annually for 5 years to assess the American Urological Association symptom score, uroflowmetry, quality of life, Symptom Problem Index, Benign Prostatic Hyperplasia Impact Index, treatment satisfaction, adverse events and need for re-treatment. RESULTS: Average treatment duration was 29 minutes. Of the 66 men 33 (50%) required no posttreatment catheterization of any kind, 25 (38%) used intermittent self-catheterization and 8 (12%) required indwelling catheterization with or without self-catheterization. No acute retention events were reported after the initial catheterization through 5 years. No serious adverse events were associated with treatment. Traditional efficacy measures showed highly significant improvement from 6 weeks and thereafter (p <0.001). A total of 19 men (29%) underwent additional medical or surgical benign prostatic hyperplasia related treatment at some time during the 5-year followup. Six men (9%) underwent surgical benign prostatic hyperplasia related treatment. At 5 years 40 of 51 men (78%) reported satisfaction with benign prostatic hyperplasia treatment. CONCLUSIONS: Cooled, high energy transurethral microwave thermal therapy using a new generation treatment catheter produced safe, durable, clinically relevant results in men with lower urinary tract symptoms caused by benign prostatic hyperplasia for 5 years after treatment with acceptable medical and surgical re-treatment rates.

Full Text

Duke Authors

Cited Authors

  • Mynderse, LA; Roehrborn, CG; Partin, AW; Preminger, GM; Coté, EP

Published Date

  • May 2011

Published In

Volume / Issue

  • 185 / 5

Start / End Page

  • 1804 - 1810

PubMed ID

  • 21420115

Pubmed Central ID

  • 21420115

Electronic International Standard Serial Number (EISSN)

  • 1527-3792

International Standard Serial Number (ISSN)

  • 0022-5347

Digital Object Identifier (DOI)

  • 10.1016/j.juro.2010.12.054

Language

  • eng