Trial Condition(s):
Study of darifenacin in patients suffering from multiple sclerosis and neurogenic detrusor overactivity
12331
Not Available
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.
- 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
- 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
Locations | |
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Locations St. Hedwig Krankenhaus Berlin, Germany, 10115 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. A.-D. Marschall-Kehrel Oberursel, Germany, 61440 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kliniken Maria Hilf GmbH Mönchengladbach, Germany, 41063 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. Stefan Carl & Dr. Achim Forth Emmendingen, Germany, 79312 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Urologische Klinik München-Planegg Planegg, Germany, 82152 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Berufsgenossenschaftl. Kliniken Bergmannstrost Halle, Germany, 06112 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Stadt Villingen-Schwenningen GmbH Villingen-Schwenningen, Germany, 78054 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. S. Laschke Lahr, Germany, 77933 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Hamburg Eppendorf (UKE) Hamburg, Germany, 20246 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Johannes-Gutenberg-Universität Mainz Mainz, Germany, 55131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Marienhospital Herne Klinik Börnig Herne, Germany, 44627 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Zentralklinik Bad Berka GmbH Bad Berka, Germany, 99437 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Heidelberg Heidelberg, Germany, 69112 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Eberhard-Karls-Universität Tübingen Tübingen, Germany, 72076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Drs. Tim Schneider /B. Schneider Mülheim, Germany, 45468 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1