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Mirabegron improves erectile function in men with overactive bladder and erectile dysfunction: a 12-week pilot study

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Abstract

Phosphodiesterase type 5 inhibitors (PDE5i) is the only approved oral treatment for erectile dysfunction (ED) in the US, and alternative management remains necessary when this treatment fails or is contraindicated. Targeting other pathways than the NO-cGMP pathway and/or combining this approach with PDE5i may introduce new treatments for men who are unresponsive to PDE5i. This study aims to evaluate whether Mirabegron improves erectile function in men with concurrent overactive bladder and mild to moderate ED. Twenty subjects, 40–70 years old, registering International Index of Erectile Function (IIEF) score 11–25 and International Prostate Symptom Score 8–20, were treated with Mirabegron therapy for 12 weeks. Study participants were re-administered IIEF and OAB-q questionnaires on weeks 2, 4, 8, and 12 and assessed for adverse events. The primary and secondary endpoints were an increase in the IIEF-5 score of 4 units and a decrease in the Overactive Bladder questionnaire (OAB-q) symptom severity score of 10 units between study time points. Thirteen men completed the 12-week study. Mirabegron treatment improved the IIEF-5 scores in five patients (38.4%) by 4 points or more, whereas IIEF-5 scores were not affected by Mirabegron treatment in eight patients (61.5%). There were no clinically relevant decreases in the IIEF-5 score. Significant improvements were observed in intercourse satisfaction at week eight compared to baseline (p = 0.01). Orgasmic function and sexual desire were not affected by Mirabegron treatment. As expected, Mirabegron treatment reduced OAB symptoms based on OAB-q short form (p = 0.006) and OAB-q total health-related quality of life (HRQL) scores compared to baseline (p = 0.03). Residual bladder volumes were not affected by treatment. No serious side effects were reported during the study period. This study suggests that Mirabegron may improve both EF and OAB-related symptoms in some individuals without causing serious adverse events.

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Fig. 1: CONSORT diagram of the clinical trial.
Fig. 2: Changes in IIEF-5 scores.
Fig. 3: Changes in OAB-q short form and OAB-q Total HRQL scores.

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Funding

This investigator-sponsored research study was provided funding and drug support by Astellas Pharma Global Development Inc.

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Authors and Affiliations

  1. The James Buchanan Brady Urological Institute and Department of Urology, The Johns Hopkins University School of Medicine, Baltimore, MD, USA

    Serkan Karakus, Biljana Musicki & Arthur L. Burnett

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  1. Serkan Karakus
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  2. Biljana Musicki
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  3. Arthur L. Burnett
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Correspondence to Arthur L. Burnett.

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Competing interests

ALB served as principal investigator on this clinical trial and he is a consultant/advisor for Astellas Pharmaceuticals.

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Karakus, S., Musicki, B. & Burnett, A.L. Mirabegron improves erectile function in men with overactive bladder and erectile dysfunction: a 12-week pilot study. Int J Impot Res 34, 588–592 (2022). https://doi.org/10.1038/s41443-021-00455-2

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  • DOI: https://doi.org/10.1038/s41443-021-00455-2

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