Condition category
Urological and Genital Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Overactive bladder syndrome (OAB) is a common condition with symptoms such as an urgent feeling to go to the toilet, going to the toilet often and sometimes leaking urine before getting to a toilet. Bladder training often cures the problem and sometimes medication is given at the same time. Mirabegron is a β3-adrenoreceptor agonist developed for treatment of overactive bladder. α1-Adrenergic receptor blockers work well for lower urinary tract symptoms (LUTS) in male patients. However, it is not known how well mirabegronl treatment in elderly male patients with persistent male LUTS performs, especially in OAB after monotherapy (therapy with a single drug) with α1-adrenergic blockers. The aim of this study is to clarify the efficacy of mirabegron as an additional treatment for male elderly patients with LUTS.

Who can participate?
Men aged at least 65 with LUTS

What does the study involve?
Participants have their usual treatment for LUTS but are also given 50g of mirabegron daily for 12 weeks. Treatment is assessed by seeing whether OAB symptoms improve.

What are the possible benefits and risks of participating?
It is expected that participants will benefit from improvement of their overactive bladder symptoms. The risk of participating is minimal, but some people may find it painful to urinate (side effect of mirabegron)

Where is the study run from?
Department of Urology and Renal Transplantation, Nagasaki University Hospital (Japan)

When is the study starting and how long is it expected to run for?
January 2012 to March 2015

Who is funding the study?
Nagasaki University Hospital (Japan)

Who is the main contact?
Dr Tomohiro Matsuo

Trial website

Contact information



Primary contact

Dr Tomohiro Matsuo


Contact details

1-7-1 Sakamoto

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

The efficacy of mirabegron additional therapy for lower urinary tract symptoms after treatment with α1-adrenergic receptor blocker monotherapy: prospective analysis of elderly men


Study hypothesis

The efficacy of mirabegron additional treatment in elderly male patients with persistent male lower urinary tract symptoms (LUTS), especially overactive bladder (OAB) symptoms after monotherapy with α1-adrenergic blockers, is not fully understood. Hence, the aim of study is to clarify it.

Ethics approval

Nagasaki University Hospital Ethical Committee, 17/11/2011, ref: 11120267

Study design

Interventional non-randomized single site study

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Persistent male lower urinary tract symptoms (LUTS) and overactive bladder (OAB) symptoms


The patients continued all of their prescribed drugs during this study period. Before and 12 weeks after mirabegron (Betanis®, Astellas Pharma Inc., Tokyo, Japan; 50 mg once daily) treatment was added to a previous α1-adrenergic receptor blocker for urinary symptoms, efficacy of the treatment was evaluated using the OABSS and International Prostate Symptom Score (IPSS) to assess subjective symptoms, and uroflowmetry and PVR was used to assess objective symptoms. We measured the maximum flow rate (Qmax) on free uroflowmetry and PVR using transabdominal ultrasound sonography. Moreover, before mirabegron add-on treatment was administered, the prostate volume (PV) was evaluated using transabdominal ultrasound sonography. During the clinical study, the current α1-adrenergic receptor blocker that the patients had been taking orally was not changed to a different one.

Intervention type


Drug names

Primary outcome measure

1. The change of total overactive bladder symptom score
2. The change of total international prostate symptom score
3. Voided volume
4. Maximum flow rate
5. Post void residual urine volume

Measured at between baseline and 12-weeks after treatment

Secondary outcome measures

1. The subscore of overactive bladder score
2. The subscore of intrenational prostate symptom score

Measured at between baseline and 12-weeks after treatment

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Male patients who had persistent lower urinary tract symptom and particularly overactive bladder symptoms, and had been taking a regular dose of α1-adrenergic receptor blockers for more than 12 weeks.
2. 65 years or older
3. total overactive bladder symptom score of 3 or more points with urinary urgency at least once per week

Participant type


Age group




Target number of participants

50 patients

Participant exclusion criteria

1. Post void urine volume of 50 mL
2. History of urinary retention
3. Prior diagnosis of neurogenic bladder
4. Urethral stricture
5. Severe hypertension (systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg) not well controlled by medication
6. Renal insufficiency (glomerular filtration rate < 30 mL/min/1.73 m2)
7. Liver impairment
8. Intention to have a child
9. Urological malignancy
10. Patients taking any anti-muscarinic drugs

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Department of Urology and Renal Transplantation, Nagasaki University Hospital
1-7-1 Sakamoto Nagasaki City

Sponsor information


Department of Urology and Renal Transplantation, Nagasaki University Hospital

Sponsor details

1-7-1 Sakamoto

Sponsor type

Hospital/treatment centre



Funder type

Hospital/treatment centre

Funder name

Nagasaki University Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Planning to publish the results in September 2016.

Intention to publish date


Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes