Abstract
Purpose
To investigate the 1-year effects of tadalafil on storage and voiding function in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (LUTS/BPH) based on a urodynamic study.
Methods
In a one-armed, prospective study, 105 untreated outpatients with LUTS/BPH received 5 mg tadalafil every day for 12 months. Subjective symptoms and objective findings on voiding and storage functions, obtained through urodynamic studies that included cystometry and pressure flow study, were evaluated before, at 3 months, and at 12 months of treatment.
Results
The analysis included 94 patients with a mean age of 70.7 years and a mean prostate volume of 44.5 mL. Subjective symptom parameters of LUTS were significantly ameliorated after 3 months, and progressively improved until study conclusion. Similarly, monitoring of storage and voiding functions revealed significant improvements after 3 months that continued to improve until 12 months. In 49 patients who revealed detrusor overactivity during cystometry at the baseline assessment, uninhibited detrusor contractions disappeared in 15 (30.6%) patients after 3 months (p = 0.02), and in 22 (44.9%) after 12 months (p < 0.001). Mean maximum flow rate significantly increased by 2.9 mL/s during the 12-month treatment (p < 0.001), whereas mean bladder outlet obstruction index significantly decreased from 59.5 at baseline to 45.7 at 3 months (p = 0.001), and to 42.9 at 12 months (p < 0.001).
Conclusions
Tadalafil significantly improved storage and voiding functions, along with LUTS, in patients with LUTS/BPH during a 1-year treatment.
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Acknowledgements
We thank all patients for participating and all trial investigators for their contribution to data acquisition and patient care.
Funding
This study has supported by funding from Nippon Shinyaku Co., Ltd, Kyoto, Japan.
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YM: Protocol/project development, Data management, Manuscript writing/editing. ST: Data analysis. TM: Manuscript writing. YF: Data analysis. NS: Data management. MK: Protocol/project development. TY: Protocol/project development. MG: Protocol/project development, Manuscript editing.
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All authors declare that they have no conflict of interest.
Ethical approval
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. The ethics committee of the Nagoya University Graduate School of Medicine approved this study protocol (IRB approval number: 2015-0106).
Informed consent
Informed consent was obtained from all individual participants included in the study before enrollment. The study was registered at https://center.umin.ac.jp as UMIN000017925.
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Matsukawa, Y., Takai, S., Majima, T. et al. Objective impacts of tadalafil on storage and voiding function in male patients with benign prostatic hyperplasia: 1-year outcomes from a prospective urodynamic study. World J Urol 37, 867–872 (2019). https://doi.org/10.1007/s00345-018-2453-x
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DOI: https://doi.org/10.1007/s00345-018-2453-x