Study of Darifenacin in Patients Suffering From Multiple Sclerosis and Neurogenic Detrusor Overactivity

Study Overview
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Brief Summary
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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.

Official Title
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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
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Multiple Sclerosis, Overactive Detrusor

Intervention / Treatment
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* Drug: Darifenacin (BAY79-4998)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Darifenacin (BAY79-4998)<br>* Darifenacin 7,5mg tablets once daily for 14 days, darifenacin 7,5mg or 15mg once daily for 14 consecutive days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in volume at first detrusor contraction as determined by urodynamics |  | At week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Darifenacin, Multiple Sclerosis, Open Label Study