Effect of Solifenacin 5mg and 10mg on Bladder Wall Thickness

• Research type

  Research Study

• Full title

  A Study to Evaluate the Overall Effect of Solifenacin 5mg and 10mg on Bladder Wall Thickness and urinary Nerve Growth Factor in Female Subjects with Overactive Bladder and a Diagnosis of Detrusor Overactivity – A double-blind, randomized, placebo-controlled, parallel group, multicentre study

• IRAS ID

  28632

• Contact name

  Dudley Robinson

• Sponsor organisation

  Astellas Pharma Europe Ltd.

• Eudract number

  2008-005215-17

• ISRCTN Number

  N/A

• Research summary

  People suffering from bladder problems, with symptoms such as frequency and urgency (with or without urge incontinence) may benefit from drug treatment. The aim of this study is to measure the effects of Solifenacin versus placebo on bladder wall thickness and urinary nerve growth factor after 12 weeks of treatment in women aged over 18 diagnosed with overactive bladder (detrusor overactivity). Patient with OAB have been shown to have a significant thickening of the bladder wall. Urinary nerve growth factor (uNGF) is produced by the muscle of the bladder and has been shown to increase in patients with OAB. It is hoped that providing patients with tangible facts with regards to their OAB could help to increase patient medication compliance. If the patient decides to enter the study and is eligible she will be given either Solifenacin (5mg) once daily, Solifenacin (10mg) once daily or a placebo tablet once daily. The study will be double-blinded so neither the patient nor the investigator will know which treatment the patient is receiving. Participants will come in for a screening visit (visit1) where if eligible for the study, they will two weeks of placebo. After the second visit (two weeks after visit 1) the participant will be randomised onto one of the three treatment arms and asked to return to the clinic after 4, 8 and 12 weeks. Therefore there are 4 visits in total. At every visit the patient will be asked to provide a urine sample. At visit 1, the patient will undergo a number of medical examinations to assess their eligibility for the study. For three days before visits 2-4 the patient will be asked to complete a voiding diary to assess urinary frequency and urgency. At visits 2-4, the patient will be asked to provide a urine sample to measure urinary nerve growth factor, undergo a trans-vaginal ultrasound to assess the bladder wall thickness and complete a number of questionnaires to assess their symptoms and treatment.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  09/H0301/77

• Date of REC Opinion

  14 Jan 2010

• REC opinion

  Further Information Favourable Opinion