Clinical Study of Solifenacin Succinate in Patients With Bladder Symptoms Due to Spinal Cord Injury or Multiple Sclerosis
Clinical Study of Solifenacin Succinate in Patients With Bladder Symptoms Due to Spinal Cord Injury or Multiple Sclerosis
A clinical study to evaluate the efficacy and safety of solifenacin in patients with bladder
 symptoms due to spinal cord injury or multiple sclerosis
A clinical study to compare the efficacy and safety of solifenacin succinate in patients with
 neurogenic detrusor overactivity. In this randomized, double blind, double dummy study
 solifenacin will be compared to placebo and an active comparator, oxybutynin hydrochloride.
 Patients will be randomized to one of four treatment arms; solifenacin 10mg, solifenacin 5mg,
 placebo or oxybutynin 15mg. Patients will be assessed over a four week treatment period.
Inclusion Criteria:

 -  Written informed consent has been obtained

 -  Subjects with neurogenic detrusor overactivity due to:

 -  Multiple sclerosis(MS)(EDSS≤8) or

 -  Spinal cord injury(SCI)(partial or complete lesions)

 -  MS or SCI symptoms should be stable for >= 6 months

 -  Neurogenic detrusor overactivity symptoms should be stable for >= 6 months

 -  Subject is willing and able to perform clean, intermittent, catheterization, if
 required

 -  Subject is willing and able to take study medication in compliance with the protocol

 Exclusion Criteria:

 -  Subjects with neurogenic detrusor overactivity due to Parkinson's or cerebrovascular
 disease

 -  Subjects with Sjögren's Syndrome or any similar symptoms

 -  Subjects with evidence of a symptomatic urinary tract infection, chronic inflammation
 such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or
 previous or current malignant disease of the pelvic organs

 -  Subjects with stress incontinence or mixed incontinence where stress is the
 predominant factor as determined by the investigator

 -  Subjects with evidence of pressure sores >= grade 2

 -  Subjects with a history of bladder sphincterotomy

 -  Subjects with known history of vesico-ureteral reflux without upper urinary tract
 infection

 -  Any clinically significant condition, which in the opinion of the investigator makes
 the subject unsuitable for the study or includes a history of acute urinary retention,
 severe gastrointestinal obstruction (including paralytic ileus or intestinal atony),
 severe gastrointestinal conditions (including toxic megacolon or ulcerative colitis),
 myasthenia gravis, narrow angle glaucoma or shallow anterior chamber

 -  Subjects undergoing hemodialysis

 -  Subjects with severe hepatic impairment

 -  Concurrent use of drugs intended to treat symptoms of overactive bladder

 -  Use of antidepressants or muscle relaxants which have not been administered at a
 constant dose for >= 3 months

 -  Use of non-drug treatment intended to treat overactive bladder symptoms including
 electrostimulation therapy, botulinum toxin and vanilloids therapy in the six months
 prior to the commencement of the study

 -  Use of permanent, indwelling catheters

 -  Known or suspected hypersensitivity to solifenacin succinate, oxybutynin
 hydrochloride, other anti cholinergics or lactose

 -  Concomitant use of a strong CYP3A4 inhibitor, e.g. ketoconazole

 -  Pregnant women, women who intend to become pregnant during the study, women of
 childbearing potential who are sexually active and practicing an unreliable method of
 birth control or women who will be lactating during the study. Reliable contraceptive
 methods are intra-uterine devices, contraceptive pills of combination type, hormonal
 implants and injectable contraceptives

 -  Participation in any clinical study within 30 days of randomization, or the limit set
 by national law, whichever is longer

 -  Employees of the Astellas Group, third parties associated with the study, or the study
 site

 -  Subjects with maximum bladder capacity >= 400ml at visit 2