Efficacy and Safety of Solifenacin Plus Tamsulosin OCAS in Men with Voiding and Storage Lower Urinary Tract Symptoms: Results from a Phase 2, Dose-finding Study (SATURN)

Philip Van Kerrebroeck*, Francois Haab, Javier C. Angulo, Viktor Vik, Ferenc Katona, Alberto Garcia-Hernandez, Monique Klaver, Klaudia Traudtner, Matthias Oelke

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

Background: Storage symptoms are often undertreated in men with lower urinary tract symptoms (LUTS). Objective: To evaluate the combination of an antimuscarinic (solifenacin) with an alpha-blocker (tamsulosin) versus tamsulosin alone in the treatment of men with LUTS. Design, setting, and participants: A double-blind, 12-wk, phase 2 study in 937 men with LUTS (>= 3 mo, total International Prostate Symptom Score [IPSS] >= 13, and maximum urinary flow rate 4.0-15.0 ml/s). Intervention: Eight treatment groups: tamsulosin oral controlled absorption system (OCAS) 0.4 mg; solifenacin 3, 6, or 9 mg; solifenacin 3, 6 or 9 mg plus tamsulosin OCAS 0.4 mg; or placebo. Outcome measurements and statistical analysis: The primary efficacy end point was change from baseline in total IPSS. Secondary end points included micturition diary and quality-of-life (QoL) parameters. Post hoc subgroup analyses were performed by severity of baseline storage symptoms, with statistical comparisons presented only for tamsulosin OCAS alone versus combination therapy, due to the small sample size of the solifenacin monotherapy and placebo subgroups. Results and limitations: Combination therapy was associated with significant improvements in micturition frequency and voided volume versus tamsulosin OCAS alone in the total study population; improvements in total IPSS were not significant. Statistically significant improvements in urgency episodes, micturition frequency, total urgency score, voided volume, IPSS storage subscore, IPSS-QoLindex, and Patient Perception of Bladder Condition were observed in a subpopulation of men with two or more urgency episodes per 24 h (Patient Perception of Intensity of Urgency Scale grade 3 or 4) and eight or more micturitions per 24 h at baseline (storage symptoms subgroup) with combination therapy versus tamsulosin OCAS alone (p
Original languageEnglish
Pages (from-to)398-407
JournalEuropean Urology
Volume64
Issue number3
DOIs
Publication statusPublished - Sep 2013

Keywords

  • Lower urinary tract symptoms
  • Overactive bladder
  • Tamsulosin OCAS
  • Solifenacin
  • Storage symptoms
  • Voiding symptoms

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