Fesoterodine fumarate for the treatment of neurogenic bladder

Treatment tested

• Fesoterodine

Other measures (1)

Inclusion: 1. Aged between 18-80 years old 2. Suffering from neurogenic detrusor overactivity, confirmed by urodynamics testing, secondary to MS or SCI of at least 6 months prior to enrollment 3. Patients suffering from MS should be clinically stable for at least 3 months prior to enrollment Exclusion: 1. UTI 2. History of urothelial cancer 3. Urolithiasis 4. Stress incontinence 5. Interstitial cystitis 6. Pelvic organ prolapsed (≥ III grade) 7. Prior pelvic surgery or pelvic radiation treatment 8. Uncontrolled narrow angle glaucoma 9. Pregnancy 10. Dementia

Background and study aims An overactive bladder is a common condition in which the bladder muscle contracts too often or without warning. This causes the sufferer to feel the need to urinate more frequently and/or urgently, the need to get up in the night to urinate and in some cases, incontinence. Neurogenic detrusor overactivity (NDO) is where the overactive bladder has an underlying neurological (nervous system) cause. NDO is most commonly seen in people with multiple sclerosis (MS) or a spinal cord injury (SCI). This happens because changes and damage to the nerves involved in bladder activity can lead to involuntary contractions of the bladder muscle leading to urinary leaking. Fesoterodine is a medication which is used to treat overactive bladder. It works by blocking a chemical in the body which triggers the contractions of the bladder, causing the bladder muscle to relax. The aim of this study is to test the safety and efficiency of using Fesoterodine to treat patients with NDO. Who can participate? Adults with an overactive bladder as a result of MS or SCI. What does the study involve? After a period of two weeks in which no medication is taken (washout period), all participants receive 8mg Fesoterodine to take every day for three months. At the start of the study and again after the three months of treatment, participants undergo a test in order to find out how well their bladder is working. The test begins with the patient emptying their bladder into a special toilet to measure the amount of urine passed and the flow. Two very thin tubes (catheters) are then placed inside the bladder in order to monitor how it fills up (one tube fills up the bladder with liquid and the other measures the pressure). Once the bladder is full, x rays are taken, before the patient is asked to empty the bladder into the special toilet again with the tubes in place. What are the possible benefits and risks of participating? Participants benefit from receiving an in depth evaluation of how well their bladder is working, as well as receiving a treatment likely to help improve their bladder function and quality of life. There are no notable risks involved for participants in this study. Where is the study run from? National Rehabilitation Center, Athens (Greece) When is the study starting and how long is it expected to run for? March 2015 to March 2018 Who is funding the study? National Rehabilitation Center, Athens (Greece) Who is the main contact? Dr Charalampos Konstantinidis