This study will assess the safety, tolerability and efficacy of SAF312 in patients with overactive bladder disease due to spinal cord lesions. The overactive bladder of patients who qualify for this study is insufficiently managed by antimuscarinic therapy, or patients poorly tolerate the treatment with antimuscarinic drugs. The efficacy of SAF312 will be primarily determined via urodynamic measurements.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
9
One week of treatment in a BID (two times a day) regimen (hard gelatin capsules for oral use)
One week of treatment in a BID (two times a day) regimen (hard gelatin capsules for oral use)
Novartis Investigative Site
Murnau am Staffelsee, Germany
Novartis Investigative Site
Nijmegen, Netherlands
Novartis Investigative Site
Zurich, Switzerland
Maximum cystometric capacity (MCC)
Examined during filling cystometry as measured by changes from baseline following treatment for one week.
Time frame: 1 week
Number of Participants with Adverse Events as a Measure of Safety
Safety (physical exam, vital signs, haematology, coagulation parameters, clinical chemistry and urinalysis, ECG, pregnancy test, hand immersion test and PK \[concentrations of SAF312 in blood\]).
Time frame: 1 week
Bladder threshold vol, threshold pressure, instilled vol at first leak, detrusor pressure at first leak, vol/detrusor pressure at first sensation and at first desire to void, maximum detrusor pressure during filling/storage, bladder wall compliance
All parameters examined during filling cystometry as measured by changes from baseline following treatment for one week
Time frame: 1 week
Micturition or catheterization frequency
Changes from baseline, as measured by daily diaries.
Time frame: 1 week
Incontinence episodes
Changes from baseline as measured by daily diaries.
Time frame: 1 week
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