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A Comparison of Boron Supplement and Tamsulosin as Medical Expulsive Therapy for Urinary Stones After Extracorporeal Shock Wave Lithotripsy: a Randomized Controlled Clinical Trial

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Abstract

Treatment with alpha-blockers has been used in many studies to facilitate stone clearance after extra-corporeal shock wave lithotripsy (ESWL), based on mediating ureteral wall relaxation. Ureteral wall edema is another barrier against the stone passage. We aimed to compare the effectiveness of boron supplement (due to its anti-inflammatory effect) and tamsulosin in the passage of stone fragments after ESWL. Eligible patients after ESWL were randomly assigned to two groups and were treated with boron supplement (10 mg/BD) or tamsulosin (0.4 mg per night) for 2 weeks. The primary outcome was the stone expulsion rate according to the remained fragmented stone burden. The secondary outcomes were the time of stone clearance, pain intensity, drug side effects, and the need for auxiliary procedures. In this randomized control trial, 200 eligible patients were treated with boron supplement or tamsulosin. Finally, 89 and 81 patients in the two groups completed the study, respectively. The expulsion rate was 46.6% in the boron and 38.7% in the tamsulosin group, which there was no statistically significant difference between the two groups (p = 0.003), as well as the time of stone clearance (7.47 ± 22.4 vs 6.52 ± 18.45, days, p = 0.648, respectively), after 2-week follow-up. Moreover, pain intensity was the same in both groups. No Significant side effects were reported in the two groups. Boron supplement could be effective as adjuvant medical expulsive therapy after ESWL with no significant side effects in short-term follow-up.

Iranian Clinical Trial Registration number and date of registration: IRCT20191026045244N3, 07/29/2020.

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Data Availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author and UNRC database on reasonable request.

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Acknowledgements

This article is taken from disease registry, titled “To evaluate and revision of registration system for recording stone formation risk factors in referring patients to Labbafinejad prevention stone clinic” and project with code number IR.SBMU.UNRC.REC.1399.023 from ethic committee, that was supported by research and technology in Shahid Beheshti University of Medical Sciences (http://dregistry.sbmu.ac.ir).

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Authors and Affiliations

  1. University of British Columbia, Vancouver, British Columbia, Canada

    Saba Jalali

  2. Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences, No. 103, Shahid Jafari (9Th Boostan) St., Pasdaran Ave, IR 1666663111, Tehran, Iran

    Nasrin Borumandnia, Abbas Basiri, Sanaz Tavasoli & Maryam Taheri

  3. Baqiyatallah University of Medical Sciences, Tehran, Islamic Republic of Iran

    Mohammadreza Nagiee

  4. Department of Epidemiology and Biostatistics, Research Centre for Emerging and Reemerging Infectious Diseases, Pasteur Institute of Iran, Tehran, Iran

    Fahimeh Bagheri Amiri

  5. Shahid Beheshti University of Medical Sciences, Tehran, IR, Iran

    Yashar Kheirolahkhani

Authors
  1. Saba Jalali
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  2. Nasrin Borumandnia
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  3. Abbas Basiri
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  4. Mohammadreza Nagiee
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  5. Fahimeh Bagheri Amiri
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Contributions

All authors contributed to the study conception and design. Material preparation and conceptualization was done by Mohammadreza Nagiee. Data collection and writing the first draft of the manuscript was done by Saba Jalali. Conducting the trial and investigation process with main revision of the manuscript were performed by Maryam Taheri. Application of statistical and mathematical or other formal techniques to analyze the study data was done by Nasrin Borumandnia and Fahimeh Bagheri Amiri. All authors commented on previous versions of the manuscript, and read and approved the final manuscript.

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Correspondence to Maryam Taheri.

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Jalali, S., Borumandnia, N., Basiri, A. et al. A Comparison of Boron Supplement and Tamsulosin as Medical Expulsive Therapy for Urinary Stones After Extracorporeal Shock Wave Lithotripsy: a Randomized Controlled Clinical Trial. Biol Trace Elem Res 201, 5126–5133 (2023). https://doi.org/10.1007/s12011-023-03597-0

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