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Randomized, controlled trial of fesoterodine fumarate for overactive bladder in Parkinson’s disease

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World Journal of Urology Aims and scope Submit manuscript

Abstract

Aims

To evaluate short-term efficacy and safety of fesoterodine fumarate in Parkinson’s disease (PD) patients with overactive bladder (OAB) symptoms.

Methods

This is a randomized, double-blind, placebo-controlled study. It also has an open-label extension phase. From May 2016 to May 2018, 63 patients were randomized to receive fesoterodine 4 mg or placebo for 4 weeks. At the end of 4 weeks of randomization phase, patients were received fesoterodine fumarate 4 mg daily for another 4 weeks at the open-label extension phase. The change in the mean number of micturition episodes per 24 h period was the primary outcome measure of the study.

Results

The number of micturition episodes per 24 h period significantly improved with the use of fesoterodine fumarate in the double-blind phase (p < 0.001). Also the mean number of nocturia and urgency episodes decreased in the fesoterodine group. In the open-label phase, the mean number of micturition, urgency and urgency urinary incontinence episodes were improved significantly. The number of nocturia episodes did not change in the open-label phase. Cognitive functions were stable after 4 weeks of fesoterodine 4 mg treatment.

Conclusions

OAB symptoms were significantly improved in older adults with PD under fesoterodine fumarate treatment, and this advantage continued in the open-label portion in the short term. In this randomized controlled study, the cognitive functions of the participants were not affected by fesoterodine 4 mg treatment compared with placebo.

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Funding

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Authors and Affiliations

  1. Department of Urology, Health Sciences University, Bozyaka Training and Research Hospital, Izmir, Turkey

    Tarik Yonguc, Ertugrul Sefik, Serdar Celik & Mehmet Erhan Aydın

  2. Department of Neurology, Health Sciences University, Bozyaka Training and Research Hospital, Izmir, Turkey

    Ipek Inci & Ozge Yılmaz Kusbeci

  3. Department of Urology, Amasya University Sabuncuoglu Serefeddin Training and Research Hospital, Amasya, Turkey

    Salih Polat

Authors
  1. Tarik Yonguc
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  2. Ertugrul Sefik
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  3. Ipek Inci
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  4. Ozge Yılmaz Kusbeci
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  5. Serdar Celik
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  6. Mehmet Erhan Aydın
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  7. Salih Polat
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Contributions

TY: Project development, data collection or management, manuscript writing/editing. SP: Data collection or management. CS: Data collection or management, Manuscript writing/editing. II: Data analysis, Manuscript writing/editing. MEA: Data analysis. KOY: Data analysis. SE: Manuscript writing/editing

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Correspondence to Tarik Yonguc.

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The authors declare that they have no conflict of interest.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Yonguc, T., Sefik, E., Inci, I. et al. Randomized, controlled trial of fesoterodine fumarate for overactive bladder in Parkinson’s disease. World J Urol 38, 2013–2019 (2020). https://doi.org/10.1007/s00345-019-02981-7

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  • DOI: https://doi.org/10.1007/s00345-019-02981-7

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