The efficacy of mirabegron additional therapy for elderly male lower urinary tract symptoms after treatment with α1-adrenergic receptor blocker
| ISRCTN | ISRCTN16759097 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16759097 |
| Secondary identifying numbers | N/A |
- Submission date
- 04/07/2016
- Registration date
- 08/07/2016
- Last edited
- 30/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
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
Contact information
Scientific
1-7-1 Sakamoto
Nagasaki
852-8501
Japan
| Phone | +81958197340 |
|---|---|
| tomo1228@nagasaki-u.ac.jp |
Study information
| Study design | Interventional non-randomized single site study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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(s) | Nagasaki University Hospital Ethical Committee, 17/11/2011, ref: 11120267 |
| 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 | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Mirabegron |
| 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 study start date | 05/01/2012 |
| Overall study end date | 31/03/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Male |
| Target number of participants | 50 patients |
| Total final enrolment | 50 |
| 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 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
Study participating centre
Nagasaki City
Nagasaki
852-8501
Japan
Sponsor information
Hospital/treatment centre
1-7-1 Sakamoto
Nagasaki
852-8501
Japan
| Phone | +81958197340 |
|---|---|
| tomo1228@nagasaki-u.ac.jp | |
"ROR" |
https://ror.org/058h74p94 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 30/09/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planning to publish the results in September 2016. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 29/07/2016 | 30/11/2020 | Yes | No |
Editorial Notes
30/11/2020: Publication reference and total final enrolment number added.
