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Clinical Trial
. 2017 Feb 6;12(2):e0170726.
doi: 10.1371/journal.pone.0170726. eCollection 2017.

Incidence of urinary retention during treatment with single tablet combinations of solifenacin+tamsulosin OCAS™ for up to 1 year in adult men with both storage and voiding LUTS: A subanalysis of the NEPTUNE/NEPTUNE II randomized controlled studies

Marcus J Drake  1   2 , Matthias Oelke  3 , Robert Snijder  4 , Monique Klaver  4 , Klaudia Traudtner  4 , Karin van Charldorp  4 , Dominique Bongaerts  4 , Philip Van Kerrebroeck  5
Affiliations
Clinical Trial

Incidence of urinary retention during treatment with single tablet combinations of solifenacin+tamsulosin OCAS™ for up to 1 year in adult men with both storage and voiding LUTS: A subanalysis of the NEPTUNE/NEPTUNE II randomized controlled studies

Marcus J Drake et al. PLoS One. .

Abstract

Introduction: The emergence of urinary retention (UR), specifically acute urinary retention (AUR), has been a concern when treating men with lower urinary tract symptoms (LUTS) with antimuscarinic drugs.

Materials and methods: In NEPTUNE (12-week, double-blind), men (≥45 years) with LUTS were randomized to receive tamsulosin oral-controlled absorption system (TOCAS) 0.4 mg, fixed-dose combination (FDC) of solifenacin (Soli) 6 mg + TOCAS 0.4 mg, FDC Soli 9 mg + TOCAS 0.4 mg, or placebo. In NEPTUNE II (40-week, open-label extension of NEPTUNE), continuing patients received 4-week FDC Soli 6 mg + TOCAS, then FDC Soli 6 mg or 9 mg + TOCAS for the remainder of the study, switchable every 3 months.

Results: Across both studies, 1208 men received ≥1 dose of FDC Soli 6 mg or 9 mg + TOCAS for up to 52 weeks; 1199 men completed NEPTUNE and 1066 received ≥1 dose in NEPTUNE II. In total, 13 men (1.1%; 95% CI, 0.6%-1.8%) reported a UR event while receiving FDC, eight of which were AUR (0.7%; 95% CI, 0.3%-1.3%, incidence 7/1000 man-years). Six men reported UR events while taking Soli 6 mg + TOCAS (three AUR), and seven men reported a UR event while taking Soli 9 mg + TOCAS (five AUR). One man developed AUR while taking TOCAS alone and four reported UR (three AUR) during placebo run-in. Most AUR/UR events occurred within 4 months of treatment initiation.

Conclusions: FDC Soli and TOCAS was associated with a low rate of UR and AUR in men with LUTS.

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Conflict of interest statement

This study was supported by Astellas Pharma Europe. Marcus J. Drake reports non-financial support from Astellas, during the conduct of the study. Outside the submitted work, he reports grants, personal fees, and non-financial support from Allergan, personal fees from Apogepha, grants and personal fees from Ferring, grants and personal fees from Pfizer, and grants, personal fees, and non-financial support from Astellas. Matthias Oelke reports non-financial support from Astellas, during the conduct of the study, and has received lecturer and/or consultant honoraria from Apogepha, Astellas, Bayer, GlaxoSmithKline, Eli Lilly and Company, Ferring, Mundipharma, Pfizer, and Recordati, and has received research grants from Astellas. Dominique Bongaerts, Monique Klaver, Robert Snijder, Klaudia Traudtner, and Karin van Charldorp are employees of Astellas Pharma Europe B.V. Philip van Kerrebroeck reports non-financial support from Astellas, during the conduct of the study, and reports personal fees from Allergan, Astellas, and Ferring, and grants from Medtronic, outside the submitted work. Following this clinical trial program, the FDC tablet of Soli 6 mg + TOCAS 0.4 mg has been registered in 42 countries (Vesomni™ or Urizia™). There are no patents or products in development to declare. This does not alter our adherence to all the PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. Study design of NEPTUNE and NEPTUNE II.
Fig 2
Fig 2
Cumulative Incidence of AUR (A) and UR (B) with FDC Soli 6 mg or 9 mg + TOCAS. (A) Acute urinary retention. (B) Urinary retention. Black markers indicate 6 mg FDC dose at time of AUR/UR onset; orange markers indicate 9 mg FDC dose at time of AUR/UR onset. AUR cases were a subgroup of UR cases that required catheterization. Abbreviation: FDC, fixed-dose combination.
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