Condition category
Urological and Genital Diseases
Date applied
04/07/2016
Date assigned
08/07/2016
Last edited
08/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
tomo1228@nagasaki-u.ac.jp

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tomohiro Matsuo

ORCID ID

Contact details

1-7-1 Sakamoto
Nagasaki
852-8501
Japan
+81958197340
tomo1228@nagasaki-u.ac.jp

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

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

Acronym

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

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

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

Intervention

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

Phase

Drug names

Primary outcome measures

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

05/01/2012

Overall trial end date

31/03/2015

Reason abandoned

Eligibility

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

Patient

Age group

Senior

Gender

Male

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

21/01/2012

Recruitment end date

30/04/2015

Locations

Countries of recruitment

Japan

Trial participating centre

Department of Urology and Renal Transplantation, Nagasaki University Hospital
1-7-1 Sakamoto Nagasaki City
Nagasaki
852-8501
Japan

Sponsor information

Organisation

Department of Urology and Renal Transplantation, Nagasaki University Hospital

Sponsor details

1-7-1 Sakamoto
Nagasaki
852-8501
Japan
+81958197340
tomo1228@nagasaki-u.ac.jp

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Nagasaki University Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planning to publish the results in September 2016.

Intention to publish date

30/09/2016

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes