Long-Term pooled analysis of multicenter studies of cooled thermotherapy for benign prostatic hyperplasia

Results at three months through four years

Bruce J. Trock, Michelle Brotzman, William J. Utz, Roland R. Ugarte, Steven A. Kaplan, Thayne R. Larson, Michael L. Blute, Claus G. Roehrborn, Alan W. Partin

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Objectives To determine the long-term efficacy of cooled thermotherapy in the treatment of lower urinary tract symptoms of clinical benign prostatic hyperplasia. Methods A total of 541 men underwent cooled thermotherapy treatment in six multicenter studies in the United States, England, and Canada. Both fixed and random effects models were used to pool the data across the six studies. The treatment response was measured as the difference between the urinary tract symptoms at baseline versus those at 3, 12, 24, 36, and 48 months after therapy. The treatment response included changes in the American Urological Association Symptom Score (AUA symptom score), peak urinary flow rate in milliliters per second (Qmax), and quality of life (QOL). Results The baseline measures were comparable across the studies. At 3 months, the AUA symptom score had improved by a mean of 11.6 (55%), Qmax by a mean of 4.0 (51%), and QOL by a mean of 2.3 (53%). These changes persisted with only slight attenuation through 48 months (corresponding mean changes of 43%, 35%, and 50%). These changes were highly statistically significant (P <0.0001 to 0.01). An improvement of at least 25% was achieved for the AUA symptom score and QOL by more than 85% of men and by more than 65% of men for Qmax. Conclusions This pooled analysis of six multicenter studies of cooled thermotherapy, involving 541 men, found highly significant improvements in AUA symptom score, Qmax, and QOL. The results were highly consistent across the studies. The improvements reflected changes from baseline values of 45% to 50% for AUA symptom score and QOL and 35% to 40% for Qmax at a follow-up duration up to 48 months after therapy. The level of improvement for all three measures remained high at 48 months, indicating that the response is durable.

Original languageEnglish (US)
Pages (from-to)716-721
Number of pages6
JournalUrology
Volume63
Issue number4
DOIs
StatePublished - Apr 2004

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Induced Hyperthermia
Prostatic Hyperplasia
Multicenter Studies
Quality of Life
Therapeutics
Lower Urinary Tract Symptoms
Urinary Tract
England
Canada

ASJC Scopus subject areas

  • Urology

Cite this

Long-Term pooled analysis of multicenter studies of cooled thermotherapy for benign prostatic hyperplasia : Results at three months through four years. / Trock, Bruce J.; Brotzman, Michelle; Utz, William J.; Ugarte, Roland R.; Kaplan, Steven A.; Larson, Thayne R.; Blute, Michael L.; Roehrborn, Claus G.; Partin, Alan W.

In: Urology, Vol. 63, No. 4, 04.2004, p. 716-721.

Research output: Contribution to journalArticle

Trock, Bruce J. ; Brotzman, Michelle ; Utz, William J. ; Ugarte, Roland R. ; Kaplan, Steven A. ; Larson, Thayne R. ; Blute, Michael L. ; Roehrborn, Claus G. ; Partin, Alan W. / Long-Term pooled analysis of multicenter studies of cooled thermotherapy for benign prostatic hyperplasia : Results at three months through four years. In: Urology. 2004 ; Vol. 63, No. 4. pp. 716-721.
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abstract = "Objectives To determine the long-term efficacy of cooled thermotherapy in the treatment of lower urinary tract symptoms of clinical benign prostatic hyperplasia. Methods A total of 541 men underwent cooled thermotherapy treatment in six multicenter studies in the United States, England, and Canada. Both fixed and random effects models were used to pool the data across the six studies. The treatment response was measured as the difference between the urinary tract symptoms at baseline versus those at 3, 12, 24, 36, and 48 months after therapy. The treatment response included changes in the American Urological Association Symptom Score (AUA symptom score), peak urinary flow rate in milliliters per second (Qmax), and quality of life (QOL). Results The baseline measures were comparable across the studies. At 3 months, the AUA symptom score had improved by a mean of 11.6 (55{\%}), Qmax by a mean of 4.0 (51{\%}), and QOL by a mean of 2.3 (53{\%}). These changes persisted with only slight attenuation through 48 months (corresponding mean changes of 43{\%}, 35{\%}, and 50{\%}). These changes were highly statistically significant (P <0.0001 to 0.01). An improvement of at least 25{\%} was achieved for the AUA symptom score and QOL by more than 85{\%} of men and by more than 65{\%} of men for Qmax. Conclusions This pooled analysis of six multicenter studies of cooled thermotherapy, involving 541 men, found highly significant improvements in AUA symptom score, Qmax, and QOL. The results were highly consistent across the studies. The improvements reflected changes from baseline values of 45{\%} to 50{\%} for AUA symptom score and QOL and 35{\%} to 40{\%} for Qmax at a follow-up duration up to 48 months after therapy. The level of improvement for all three measures remained high at 48 months, indicating that the response is durable.",
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AU - Ugarte, Roland R.

AU - Kaplan, Steven A.

AU - Larson, Thayne R.

AU - Blute, Michael L.

AU - Roehrborn, Claus G.

AU - Partin, Alan W.

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N2 - Objectives To determine the long-term efficacy of cooled thermotherapy in the treatment of lower urinary tract symptoms of clinical benign prostatic hyperplasia. Methods A total of 541 men underwent cooled thermotherapy treatment in six multicenter studies in the United States, England, and Canada. Both fixed and random effects models were used to pool the data across the six studies. The treatment response was measured as the difference between the urinary tract symptoms at baseline versus those at 3, 12, 24, 36, and 48 months after therapy. The treatment response included changes in the American Urological Association Symptom Score (AUA symptom score), peak urinary flow rate in milliliters per second (Qmax), and quality of life (QOL). Results The baseline measures were comparable across the studies. At 3 months, the AUA symptom score had improved by a mean of 11.6 (55%), Qmax by a mean of 4.0 (51%), and QOL by a mean of 2.3 (53%). These changes persisted with only slight attenuation through 48 months (corresponding mean changes of 43%, 35%, and 50%). These changes were highly statistically significant (P <0.0001 to 0.01). An improvement of at least 25% was achieved for the AUA symptom score and QOL by more than 85% of men and by more than 65% of men for Qmax. Conclusions This pooled analysis of six multicenter studies of cooled thermotherapy, involving 541 men, found highly significant improvements in AUA symptom score, Qmax, and QOL. The results were highly consistent across the studies. The improvements reflected changes from baseline values of 45% to 50% for AUA symptom score and QOL and 35% to 40% for Qmax at a follow-up duration up to 48 months after therapy. The level of improvement for all three measures remained high at 48 months, indicating that the response is durable.

AB - Objectives To determine the long-term efficacy of cooled thermotherapy in the treatment of lower urinary tract symptoms of clinical benign prostatic hyperplasia. Methods A total of 541 men underwent cooled thermotherapy treatment in six multicenter studies in the United States, England, and Canada. Both fixed and random effects models were used to pool the data across the six studies. The treatment response was measured as the difference between the urinary tract symptoms at baseline versus those at 3, 12, 24, 36, and 48 months after therapy. The treatment response included changes in the American Urological Association Symptom Score (AUA symptom score), peak urinary flow rate in milliliters per second (Qmax), and quality of life (QOL). Results The baseline measures were comparable across the studies. At 3 months, the AUA symptom score had improved by a mean of 11.6 (55%), Qmax by a mean of 4.0 (51%), and QOL by a mean of 2.3 (53%). These changes persisted with only slight attenuation through 48 months (corresponding mean changes of 43%, 35%, and 50%). These changes were highly statistically significant (P <0.0001 to 0.01). An improvement of at least 25% was achieved for the AUA symptom score and QOL by more than 85% of men and by more than 65% of men for Qmax. Conclusions This pooled analysis of six multicenter studies of cooled thermotherapy, involving 541 men, found highly significant improvements in AUA symptom score, Qmax, and QOL. The results were highly consistent across the studies. The improvements reflected changes from baseline values of 45% to 50% for AUA symptom score and QOL and 35% to 40% for Qmax at a follow-up duration up to 48 months after therapy. The level of improvement for all three measures remained high at 48 months, indicating that the response is durable.

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