The purpose of this clinical study is to compare efficacy and safety of propiverine hydrochloride extended and immediate release formulations in patients suffering from neurogenic detrusor overactivity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
66
45 mg capsule (1x1/d)
15 mg tablet (3x1/d)
Unnamed facility
Graz, Austria
Unnamed facility
Hagenow, Germany
Unnamed facility
Bucharest, Romania
Reflex volume (cystometry)
Change in reflex volume compared to baseline and compared between the two treatment arms
Time frame: three weeks
Leak point pressure
Change in LPP compared to baseline and compared between the two treatment arms
Time frame: three weeks
Leak point volume
Change in LPV compared to baseline and compared between the two treatment arms
Time frame: three weeks
Maximum detrusor pressure
Change in maximum p det compared to baseline and compared between the two treatment arms
Time frame: three weeks
Maximum cystometric capacity
Change in maximum cystometric capacity compared to baseline and compared between the two treatment arms
Time frame: three weeks
Bladder compliance
Change in compliance compared to baseline and compared between the two treatment arms
Time frame: three weeks
Change in number of incontinence episodes
Change of incontinence episodes compared to baseline and compared between the two treatment arms
Time frame: three weeks
State of Well-Being Questionnaire
Change of well-beeing compared to baseline and compared between the two treatment arms
Time frame: three weeks
Post void residual volume
Change in PVR compared to baseline and compared between the two treatment arms
Time frame: three weeks
Incidence and severity of adverse events
occurrences and intensity of adverse events or withdrawals over the whole treatment period
Time frame: three weeks
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