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Naftopidil versus flopropione as medical expulsive therapy for distal ureteral stones: results of a randomized, multicenter, double-blind, controlled trial

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Abstract

Purpose

A multicenter, double-blind, randomized, controlled trial was conducted to determine the efficacy of naftopidil as medical expulsive therapy (MET) for patients with distal ureteral stones.

Methods

Ninety-two patients presenting with a single distal ureteral stone ≤10 mm were randomly assigned to receive either naftopidil (75 mg of naftopidil once in the morning and placebo twice a day) or flopropione (80 mg three times a day). The primary end point was time to stone expulsion calculated by the Kaplan–Meier method. Secondary end points were the percentages of patients who required analgesics, hospital admission, and surgery, the number of working days lost to the disease, and treatment safety.

Results

Overall, three patients were excluded from the final analysis. No significant differences were noted in age, stone size, and stone side between the treatment arms. The median time to stone expulsion was 8 days [95 % confidence interval (CI), 3–16] for the naftopidil group, and this was significantly less than the 18 days (95 % CI, 11 to not reached) for the flopropione group (p = 0.03). On multivariate Cox regression analysis, the hazard of expulsion was 1.8-fold higher for the naftopidil group than for the flopropione group after adjustment for age, sex, stone side, and stone size. No significant differences were noted in the secondary end points.

Conclusions

The administration of naftopidil significantly improved time to stone expulsion in patients with distal ureteral stones ≤10 mm. We believe that this is the first multicenter, double-blind, randomized, controlled trial demonstrating the efficacy of naftopidil for MET.

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Conflict of interest

The authors declare that they have no conflict of interest.

Ethical standard

The study was approved by the Institutional Review Board of Wakayama Medical University (registration No. 385) and therefore was performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments.

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Authors and Affiliations

  1. Department of Urology, Wakayama Medical University, 811-1 Kimiidera, Wakayama, 641-8509, Japan

    Yasuo Kohjimoto, Akinori Iba, Nagahide Matsumura & Isao Hara

  2. Department of Urology, Rinku General Medical Center, Osaka, Japan

    Keizo Hagino

  3. Department of Urology, Kainan Iryou Center, Wakayama, Japan

    Takatoshi Ogawa

  4. Department of Urology, Kinan Hospital, Wakayama, Japan

    Takeshi Inagaki

  5. Kitamura Urology and Internal Clinic, Wakayama, Japan

    Shinji Kitamura

  6. Department of Urology, Kishiwada Tokushukai Hospital, Osaka, Japan

    Masaya Nishihata

Authors
  1. Yasuo Kohjimoto
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  2. Keizo Hagino
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  3. Takatoshi Ogawa
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  4. Takeshi Inagaki
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  5. Shinji Kitamura
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  6. Masaya Nishihata
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  7. Akinori Iba
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  8. Nagahide Matsumura
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  9. Isao Hara
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Corresponding author

Correspondence to Yasuo Kohjimoto.

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Cite this article

Kohjimoto, Y., Hagino, K., Ogawa, T. et al. Naftopidil versus flopropione as medical expulsive therapy for distal ureteral stones: results of a randomized, multicenter, double-blind, controlled trial. World J Urol 33, 2125–2129 (2015). https://doi.org/10.1007/s00345-015-1556-x

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  • DOI: https://doi.org/10.1007/s00345-015-1556-x

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