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Posted by on Jan 12, 2019 in Benign prostatic hyperplasia | 0 comments

In a nutshell

This study looked at the safety and effectiveness of mirabegron (Myrbetriq) in treating overactive bladder (OAB) in men. It concluded that mirabegron was a safe and effective OAB treatment in men. 

Some background

Overactive Bladder (OAB) is a sudden, frequent urge to urinate. It may result in urge incontinence (inability to hold on to urine). OAB urination is usually eight or more times a day and two or more times at night. OAB can have a negative impact on quality of life. Medications can be taken to calm the muscles and nerves which cause OAB. These medications however, can carry side effects. Mirabegron is an OAB medication. It relaxes the muscles of the bladder. 

Methods & findings

464 men were included in the study. These men had OAB. Patients were divided into two groups. Group one received 50mg of mirabegron every day for 12 weeks. Group 2 received a placebo everyday for 12 weeks. Patients were assessed for a change in average urinations per day, a change in OAB symptom severity and a change in prostate symptoms. These assessments were compared between the two groups. Safety was also assessed. This was assessed through complications, blood pressure, pulse rate, volume of urine retained after urination and maximum rate of urine flow. After 12 weeks, every patient was put on 50mg of mirabegron daily for a further 14 weeks. 

The number of urinations per day was similar between the two groups after 12 weeks. OAB symptom severity and prostate symptoms improved more in the mirabegron group (Group 1). In the extended 14 week period, there was no difference between groups in urinations per day, OAB symptom severity or prostate symptoms. 15.48% of the mirabegron groups suffered complications. 11.69% of the placebo group (treatment with no active effect for comparison) suffered complications. These complications included allergic reactions, stomach and gut problems and heart problems. In the 14 week extended period, 4.84% of mirabegron patients and 6.49% of placebo patients suffered complications. The differences in complications between Group 1 and Group 2 were not significant however. Death due to heart attack occurred in one patient on mirabegron. This was unconnected to mirabegron however. In the extended period, one patient on mirabegron suffered from angina. Angina is reduced blood flow to the heart causing chest pain. This was resolved. Changes in blood pressure, pulse rate, urine flow rate and volume of urine retained after urination did not differ between groups. 

The bottom line

This study concluded that mirabegron is safe and effective in male OAB treatment. 

The fine print

The authors note that the mirabegron group had similar reduction in urinations per day to the placebo group. This may affect the study's results. 

What’s next?

To learn more about mirabegron in male OAB treatment, contact your doctor. 

Published By :

Neurourology and urodynamics

Date :

Oct 12, 2018

Original Title :

Mirabegron as a treatment for overactive bladder symptoms in men (MIRACLE study): Efficacy and safety results from a multicenter, randomized, double-blind, placebo-controlled, parallel comparison phase IV study.

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