Fesoterodine and sexual function, Version 1.7

• Research type

  Research Study

• Full title

  A 12 week, single centre, open label study to evaluate the effect of fesoterodine flexible dosing regimen on the sexual function of women with overactive bladder.

• IRAS ID

  48710

• Contact name

  Miss Angela Rantell

• Sponsor organisation

  King’s College Hospital NHS Foundation Trust

• Eudract number

  2010-023851-27

• ISRCTN Number

  ISRCTN40720691

• Research summary

  The Overactive bladder Syndrome is the term used to describe the symptom complex of urinary urgency with or without urge incontinence, usually with frequency and nocturia, in the absence of urinary tract infection or other obvious pathology (Haylen et al 2010). It is reported that the prevalence of OAB in the general population is 14-16% (Irwin et al 2006). OAB is a distressing problem that can seriously affect an individual??s quality of life by forcing them to alter their social, physical, occupational and sexual activities (Kelleher 1997). Anticholinergic drugs (also known as antimuscarinics) are the mainstay of treatment for OAB symptoms. In the UK in 2007, 2.85 million prescriptions were written for anticholinergic drugs (Roesner and Wagg 2007). Fesoterodine fumarate is a new addition to this class of drug and is available as prolonged release tablets in flexible dosing (4mg and 8mg). It has been found to effective in the treatment of women with OAB in several multi-centre international trails (Cardozo et al 2010, Sand et al 2008, Herschorn et al 2009, Wyndaele et al 2009).There have been many studies that show the negative impact of OAB on sexual function (Salonia et al 2004, Milson et al 2009, Coyne 2008, Chen et al 2003, Kim et al 2005, Sand et al 2006). However, there is very little evidence looking at the effect of anticholinergics on sexual function. This study aims to assess the impact of fesoterodine of the sexual function of women with OAB.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  12/EE/0029

• Date of REC Opinion

  14 Jun 2012

• REC opinion

  Further Information Favourable Opinion