Clinical trial NCT00845338: Study of Darifenacin in Patients Suffering From Multiple Sclerosis and Neurogenic Detrusor Overactivity
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Multiple Sclerosis
Overactive Detrusor
Keywords: Darifenacin
Multiple Sclerosis
Open Label Study
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-02-18
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change from baseline in volume at first detrusor contraction as determined by urodynamics
timeFrame: At week 4
Secondary outcomes:
measure: Detrusor pressure at first contraction
timeFrame: At week 4
measure: Volume at first detectable leakage
timeFrame: At week 4
measure: Volume at 10/20/30/40 cm H2O
timeFrame: At week 4
measure: Compliance
timeFrame: At week 4
measure: Maximum cystometric bladder capacity
timeFrame: At week 4
measure: 7-day micturition diary: Micturitions
timeFrame: At days 0, 14, 28
measure: 7-day micturition diary: Urgency episodes
timeFrame: At days 0, 14, 28
measure: 7-day micturition diary: Urge urinary incontinence episodes
timeFrame: At days 0, 14, 28
Other outcomes:
Locations:
city: Emmendingen
country: Germany
state: Baden-Württemberg
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: Lahr
country: Germany
state: Baden-Württemberg
city: Tübingen
country: Germany
state: Baden-Württemberg
city: Villingen-Schwenningen
country: Germany
state: Baden-Württemberg
city: Planegg
country: Germany
state: Bayern
city: Oberursel
country: Germany
state: Hessen
city: Herne
country: Germany
state: Nordrhein-Westfalen
city: Mönchengladbach
country: Germany
state: Nordrhein-Westfalen
city: Mülheim
country: Germany
state: Nordrhein-Westfalen
city: Mainz
country: Germany
state: Rheinland-Pfalz
city: Halle
country: Germany
state: Sachsen-Anhalt
city: Bad Berka
country: Germany
state: Thüringen
city: Berlin
country: Germany
city: Hamburg
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: