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The treatment of neurogenic lower urinary tract dysfunction in persons with spinal cord injury: An open label, pilot study of anticholinergic agent vs. mirabegron to evaluate cognitive impact and efficacy

Abstract

Study design

Pre–post intervention.

Objectives

  1. 1.

    To test whether replacement of oral anticholinergic (AC) agents with mirabegron for neurogenic lower urinary tract dysfunction (NLUTD) yields improved cognitive function in older persons with spinal cord injury (SCI).

  2. 2.

    To test whether mirabegron is safe and as efficacious as AC.

Setting

USA.

Methods

Pilot study: Twenty older (>60 y/o) persons with SCI taking chronic (>6 months) AC medication for NLUTD were enrolled. All participants were first studied on AC at baseline then switched to mirabegron for 6 months. Primary outcomes were cognitive tests of (1) executive function (TEXAS, SDMT); (2) attention (SCWT); and (3) memory (SLUMS and WMS-IV Story A/B). Secondary outcomes assessed efficacy and safety including Neurogenic Bladder Symptom Score (NBSS), bladder diary, neurogenic bowel dysfunction (NBD) survey, heart rate (HR), electrocardiogram (EKG), and mean arterial pressure (MAP).

Results

When switching from AC to mirabegron for NLUTD, older persons with SCI exhibited statistically significant improvements in immediate Story A recall (p = 0.01), delayed story A and B recall (p = 0.01, 0.004), and in TEXAS (p = 0.04). Three subscores within NBSS significantly improved (p = 0.001) and the frequency of incontinence decreased (p = 0.03) on mirabegron. NBD, HR, MAP, and EKGs were unchanged.

Conclusions

Older persons with SCI on AC for NLUTD demonstrated improved short-term and delayed memory (WMS-IV Story A/B) as well as executive function (TEXAS) when switched to mirabegron. Efficacy of mirabegron for NLUTD symptoms was superior to AC with no adverse effects on bowel or cardiovascular function.

Sponsorship

Claude D. Pepper Older Americans Independence Center.

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Fig. 1: Consort chart.
Fig. 2: Scores from memory assessments of Weschler Memory Scale IV (WMSIV).
Fig. 3: Executive function test scores on AC (V1) vs. mirabegron (V7).
Fig. 4: Neurogenic bladder symptom score results.

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Acknowledgements

This material is the result of work supported with resources and the use of facilities at the Audie L. Murphy Veteran’s Affairs Hospital in San Antonio, TX.

Funding

Funding is provided by Claude D. Pepper Older Americans Idependence Center.

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Correspondence to Michelle Trbovich.

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Conflict of interest

While SK (author) does acknowledge conflict of interest with the manufacturer of Mirabegron (Astellas), he did not have access to data from the study that could have potentially created bias in results.

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Trbovich, M., Romo, T., Polk, M. et al. The treatment of neurogenic lower urinary tract dysfunction in persons with spinal cord injury: An open label, pilot study of anticholinergic agent vs. mirabegron to evaluate cognitive impact and efficacy. Spinal Cord Ser Cases 7, 50 (2021). https://doi.org/10.1038/s41394-021-00413-6

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