PLUS (178-MA-1008)
Research type
Research Study
Full title
A Phase 4, Double-Blind, Randomized, Placebo-controlled, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men with Overactive Bladder (OAB) Symptoms While Taking the Alpha Blocker Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH)
IRAS ID
200765
Contact name
Chris Chapple
Contact email
Sponsor organisation
Astellas Pharma Global Development, Inc.
Eudract number
2015-004036-36
Duration of Study in the UK
1 years, 8 months, 31 days
Research summary
Benign prostatic hyperplasia (BPH) is a non cancerous enlargement of the prostate in men. The enlargement impinges on the urethra and obstructs the flow of urine. BPH is a common cause of lower urinary tract symptoms (LUTS) such as frequent urination, urgency, nocturia (waking to go to the toilet), and the sensation of incomplete bladder emptying. LUTS can be divided into storage and voiding symptoms, with BPH predominantly associated with voiding LUTS symptoms. Alpha-blockers, such as tamsulosin hydrochloride, are commonly prescribed to manage BPH symptoms.
Overactive bladder syndrome (OAB) is a medical condition which causes sudden involuntary muscle contractions in the wall of the urinary bladder and is associated with storage LUTS symptoms. Mirabegron is an approved treatment of OAB and works to relax the bladder and increase its capacity.
In clinical practice, it is recognised that men with BPH may experience OAB symptoms at the same time. Alpha-blockers, such as tamsulosin hydrochloride, may fail to alleviate the OAB storage symptoms. It is anticipated from previous studies of add-on therapies, that the combination of mirabegron and tamsulosin hydrochloride will show an added benefit over only having a single therapy with an Alpha-blocker in improving OAB-related symptoms. To see if having both mirabegron and tamsulosin hydrochloride at the same time will help those patients with BPH and OAB, this study will aim to recruit patients who have been taking tamsulosin hydrochloride as part of their standard of care, and after a run-in period of 4 weeks being on sponsor provided tamsulosin hydrochloride, the subjects are randomised to mirabegron or placebo for a total period of 12 weeks. The study’s main efficacy endpoint will be the mean number of micturitions (voluntary urination) per day based on a 3 day diary completed by the subjects.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
16/YH/0186
Date of REC Opinion
8 Jun 2016
REC opinion
Further Information Favourable Opinion