Study of Darifenacin in Patients Suffering From Multiple Sclerosis and
A 4-week, Open-label, Multicenter, Urodynamic Pilot Study to Explore the Efficacy, Tolerability and Safety of Darifenacin (7.5 mg With Up-titration to 15 mg) in Patients With Multiple Sclerosis and Neurogenic Detrusor Overactivity
What it found
The trial ended early for another reason (see below).
Reason given: The enrollment rate at most centers was unlikely to result in the recruitment of the planned sample size of 40 evaluable subjects.
This trial finished 19 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Darifenacin
What it measured
Main measures
Change from baseline in volume at first detrusor contraction as determined by urodynamics
At week 4
• volume at first detrusor contraction
Other measures (8)
Detrusor pressure at first contraction
At week 4
Volume at first detectable leakage
At week 4
Volume at 10/20/30/40 cm H2O
At week 4
Compliance
At week 4
Maximum cystometric bladder capacity
At week 4
Bladder, bowel and sexual function7-day micturition diary: Micturitions
At days 0, 14, 28
7-day micturition diary: Urgency episodes
At days 0, 14, 28
7-day micturition diary: Urge urinary incontinence episodes
At days 0, 14, 28
Bladder, bowel and sexual function
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
Inclusion criteria
* Patients with multiple sclerosis for at least 6 months * Neurogenic detrusor overactivity without DSD * Symptoms of OAB * Patients capable of completing the bladder diary * Patients capable of independent toileting * Patients able to swallow the study medication in accordance to the protocol * Body Mass Index >/= 18,8 kg/qm and \</= 35,0 kg/qm * documented, dated, written informed consent
Exclusion criteria
* Treatment with drugs known to affect mainly the urinary function 14 days prior to starting completion of the baseline diary for Visit 2 * Participation in a bladder-training program * Low compliance bladder (Compliance \<20 mL/cm H2O) * DSD, Detrusor hyporeflexia / areflexia and bradykinesia / tremor of the external urethral sphincter * Indwelling catheter or intermittent self-catheterization * Patience with post-void residual (PVR) urinary volume > 200 mL at baseline * Urinary retention or clinically significant bladder outlet obstruction as detected by the investigator * Clinically predominant and bothersome stress urinary incontinence * Neurological diseases other than multiple sclerosis affecting urinary bladder function * Any urogenital surgery within 12 month prior to Visit 1 * 17 Additional Exclusion Criteria
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The objective of this study is to explore the effects of darifenacin in patients with multiple sclerosis and neurogenic detrusor overactivity. The efficacy, safety and tolerability of darifenacin are already well established in idiopathic detrusor overactivity. Patients with multiple sclerosis and neurogenic detrusor overactivity without detrusor-sphincter-dyssynergia (DSD) will be allocated to darifenacin therapy.
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History
Started
Feb 2007
Main results due
Oct 2007
Finished
Oct 2007