NCT00845338TerminatedPhase 2
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Bayer
- Enrollment
- 7
- Primary Endpoint
- Change from baseline in volume at first detrusor contraction as determined by urodynamics
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Arm 1
Experimental
Intervention: Darifenacin (BAY79-4998) (Drug)
Outcomes
Primary Outcomes
Change from baseline in volume at first detrusor contraction as determined by urodynamics
Time Frame: At week 4
Secondary Outcomes
- Compliance(At week 4)
- 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)
- Maximum cystometric bladder capacity(At week 4)
- 7-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)
Investigators
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