BEYOND Study

• Research type

  Research Study

• Full title

  A Double-Blind, Randomized, Parallel Group, Multi-Centre Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Subjects with Overactive Bladder (OAB) Treated with Antimuscarinics and Dissatisfied due to Lack of Efficacy

• IRAS ID

  100476

• Contact name

  Vik Khullar

• Sponsor organisation

  Astellas Pharma Europe Ltd

• Eudract number

  2011-005713-37

• ISRCTN Number

  rrr

• Research summary

  Overactive bladder syndrome (OAB) is a medical condition which causes sudden involuntary muscle contractions in the wall of the urinary bladder. This muscle contraction can cause a sudden and unstoppable need to urinate (urinary urgency), often leading to unintentional loss of urine (urge incontinence). It is a highly common condition and current drug therapy consists mainly of antimuscarinics. The pathophysiology of OAB is not fully understood, but it is likely that antimuscarinic drugs act by inhibiting the M3 subtype of muscarinic receptors in the urinary bladder, leading to a decrease in involuntary detrusor contractions and increased bladder filling, thereby reducing storage symptoms. Muscarinic receptors are also found in other tissues such as the salivary gland, intestine and eye, which mean that the use of antimuscarinic agents can give rise to anticholinergic-type adverse events such as dry mouth, constipation and blurred vision. Development of drugs with a different mode of action to the muscarinic receptor antagonists may therefore result in treatment options with a better benefit/risk ratio than the currently available compounds. It is considered that detrusor relaxation by activation of sympathetic nerves is mediated primarily via the Beta 3-Adrenoreceptors (AR??s), which is the adrenergic receptor in the human bladder responsible for detrusor muscle relaxation. Data supports a likely role for Beta 3-ARs in promoting urine storage in the bladder and suggest a therapeutic potential for drugs acting at Beta 3-ARs. The primary objective is to assess the efficacy of mirabegron 50mg versus solifenacin 5mg in the treatment of subjects with OAB who were dissatisfied with their treatment due to lack of efficacy and the secondary objective is to assess the safety and tolerability. A total of 718 evaluable subjects per treatment arm are required across approximately 250 centres across EU and non-EU countries.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  12/LO/0410

• Date of REC Opinion

  23 Apr 2012

• REC opinion

  Further Information Favourable Opinion