Quantifying the Contribution of symptom improvement to satisfaction of men with moderate to severe benign prostatic hyperplasia: 4-year data from the CombAT trial

Claus Roehrborn, Timothy H. Wilson, Libby K. Black

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Purpose: We quantified the magnitude of symptom improvement required to achieve different levels of patient reported satisfaction, as assessed by the Patient Perception of Study Medication questionnaire. Materials and Methods: This multicenter, international, double-blind, randomized study included men 50 years old or older with International Prostate Symptom Score 12 or greater, prostate volume 30 cc or greater, total prostate specific antigen 1.5 to 10.0 ng/ml, maximum urinary flow greater than 5 and less than or equal to 15 ml per second and minimum voided volume 125 ml or greater. Patients were randomized to dutasteride (0.5 mg) and/or tamsulosin (0.4 mg) but results are reported without respect to treatment. International Prostate Symptom Score and Patient Perception of Study Medication responses were assessed at baseline and at 3-month intervals for 48 months. Using pooled data Patient Perception of Study Medication responses were correlated with changes in International Prostate Symptom Score from baseline for 2 Patient Perception of Study Medication measures, including 1) total score and 2) overall satisfaction on question 11, "Overall how satisfied are you with the study medication and its effect on your urinary problems?" Results: Patient Perception of Study Medication total score and question 11 correlated significantly with the mean change in International Prostate Symptom Score from baseline (p <0.0001). A response of very satisfied to question 11 was associated with an International Prostate Symptom Score improvement of -9.4 points while a response of very dissatisfied was associated with 1.3-point worsening. There was only moderate correlation between Patient Perception of Study Medication question 11 and changes in symptoms (r = 0.38). Thus, factors other than lower urinary tract symptoms also contribute to satisfaction and they could not be formally analyzed in this report. Conclusions: We noted correlations between patient satisfaction and the magnitude of the International Prostate Symptom Score change from baseline, which allowed us to determine treatment outcomes in terms of true clinical instead of only statistical significance.

Original languageEnglish (US)
Pages (from-to)1732-1738
Number of pages7
JournalJournal of Urology
Volume187
Issue number5
DOIs
StatePublished - May 2012

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Prostatic Hyperplasia
Prostate
tamsulosin
Patient Satisfaction
Lower Urinary Tract Symptoms
Prostate-Specific Antigen
Double-Blind Method

Keywords

  • biomarkers
  • pharmacological
  • prostate
  • prostatic hyperplasia
  • questionnaires
  • urination disorders

ASJC Scopus subject areas

  • Urology

Cite this

Quantifying the Contribution of symptom improvement to satisfaction of men with moderate to severe benign prostatic hyperplasia : 4-year data from the CombAT trial. / Roehrborn, Claus; Wilson, Timothy H.; Black, Libby K.

In: Journal of Urology, Vol. 187, No. 5, 05.2012, p. 1732-1738.

Research output: Contribution to journalArticle

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