Effect of tadalafil on male lower urinary tract symptoms: An integrated analysis of storage and voiding international prostate symptom subscores from four randomised controlled trials

Christopher R. Chapple, Claus Roehrborn, Kevin McVary, Dapo Ilo, Carsten Henneges, Lars Viktrup

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

Background The international prostate symptom score (IPSS) evaluates lower urinary tract symptoms (LUTS) in men with suspected benign prostatic hyperplasia (BPH); the total score does not differentiate between storage and voiding and is unevenly weighted (four questions [57%] on voiding, three questions [43%] on storage). Objective To evaluate the relative contributions of storage and voiding IPSS subscores to total IPSS at baseline and in response to treatment with tadalafil. Design, setting, and participants Integrated analysis of data from four placebo-controlled, 12-wk studies of tadalafil (5 mg once daily) in 1499 men with LUTS/BPH. Outcome measurements and statistical analysis Relationships between total IPSS and the storage and voiding subscores were assessed using graphical exploration and linear regression modelling. Linear modelling was performed for the baseline and endpoint and for changes in subscores. The optimal storage subscore to total IPSS (S:T) ratio for IPSS improvement was identified using nonparametric regression and gradient-descent optimisation. Results and limitations The contribution of storage and voiding subscores at baseline and endpoint was 38.8% and 61.2%, and 39.2% and 60.7%, respectively. This intuitive 40:60 storage-to-voiding ratio was similar at baseline and endpoint by treatment group and for changes in subscores, but spanned the entire range for individuals. Changes in total IPSS were greatest for a storage subscore percentage contribution to total IPSS of 42.7%. There was no statistical association between S:T ratio (≥40% vs

Original languageEnglish (US)
Pages (from-to)114-122
Number of pages9
JournalEuropean Urology
Volume67
Issue number1
DOIs
StatePublished - Jan 1 2015

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Lower Urinary Tract Symptoms
Prostate
Randomized Controlled Trials
Prostatic Hyperplasia
Tadalafil
Linear Models
Placebos
Therapeutics

Keywords

  • Benign prostatic hyperplasia
  • International prostate symptom score
  • Lower urinary tract symptoms
  • Storage
  • Tadalafil
  • Voiding

ASJC Scopus subject areas

  • Urology

Cite this

Effect of tadalafil on male lower urinary tract symptoms : An integrated analysis of storage and voiding international prostate symptom subscores from four randomised controlled trials. / Chapple, Christopher R.; Roehrborn, Claus; McVary, Kevin; Ilo, Dapo; Henneges, Carsten; Viktrup, Lars.

In: European Urology, Vol. 67, No. 1, 01.01.2015, p. 114-122.

Research output: Contribution to journalArticle

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abstract = "Background The international prostate symptom score (IPSS) evaluates lower urinary tract symptoms (LUTS) in men with suspected benign prostatic hyperplasia (BPH); the total score does not differentiate between storage and voiding and is unevenly weighted (four questions [57{\%}] on voiding, three questions [43{\%}] on storage). Objective To evaluate the relative contributions of storage and voiding IPSS subscores to total IPSS at baseline and in response to treatment with tadalafil. Design, setting, and participants Integrated analysis of data from four placebo-controlled, 12-wk studies of tadalafil (5 mg once daily) in 1499 men with LUTS/BPH. Outcome measurements and statistical analysis Relationships between total IPSS and the storage and voiding subscores were assessed using graphical exploration and linear regression modelling. Linear modelling was performed for the baseline and endpoint and for changes in subscores. The optimal storage subscore to total IPSS (S:T) ratio for IPSS improvement was identified using nonparametric regression and gradient-descent optimisation. Results and limitations The contribution of storage and voiding subscores at baseline and endpoint was 38.8{\%} and 61.2{\%}, and 39.2{\%} and 60.7{\%}, respectively. This intuitive 40:60 storage-to-voiding ratio was similar at baseline and endpoint by treatment group and for changes in subscores, but spanned the entire range for individuals. Changes in total IPSS were greatest for a storage subscore percentage contribution to total IPSS of 42.7{\%}. There was no statistical association between S:T ratio (≥40{\%} vs",
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