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

Lance A. Mynderse, Claus Roehrborn, Alan W. Partin, Glenn M. Preminger, Eric P. Coté

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1804-1810
Number of pages7
JournalJournal of Urology
Volume185
Issue number5
DOIs
StatePublished - May 2011

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Prostatic Hyperplasia
Microwaves
Multicenter Studies
Catheters
Hot Temperature
Catheterization
Therapeutics
Lower Urinary Tract Symptoms

Keywords

  • catheterization
  • hyperthermia, induced
  • microwaves
  • prostate
  • prostatic hyperplasia

ASJC Scopus subject areas

  • Urology

Cite this

Results of a 5-year multicenter trial of a new generation cooled high energy transurethral microwave thermal therapy catheter for benign prostatic hyperplasia. / Mynderse, Lance A.; Roehrborn, Claus; Partin, Alan W.; Preminger, Glenn M.; Coté, Eric P.

In: Journal of Urology, Vol. 185, No. 5, 05.2011, p. 1804-1810.

Research output: Contribution to journalArticle

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abstract = "Purpose: We determined the safety, effectiveness and 5-year durability of the new generation, cooled, high energy microwave treatment Cooled ThermoCath{\circledR} catheter with the Targis{\circledR} 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.",
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N2 - 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.

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