The aim of the study is to determine how well the drug BAY1817080 works in OAB patients with urgency urinary incontinence (UUI), defined as involuntary leakage of urine, accompanied or immediately preceded by a sudden compelling desire to void. BAY1817080 is a new drug under development which blocks proteins expressed on the sensory nerves in the bladder. These nerves seem to overreact in OAB patients. This study will test if the treatment with BAY1817080 will reduce the frequency of OAB symptoms. The frequency of OAB symptoms before the treatment and the frequency after 4, 8 and 12 weeks of treatment will be compared. Another important objective of this study will be the assessment of BAY1817080 safety and tolerability in this patient population. BAY1817080 will be compared to a "placebo". A placebo tablet looks like the study drug but does not have any medicine in it. Using a placebo helps to learn if the study drug works. Each participant is expected to take part in the study for about 5 months (around 20-22 weeks).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
99
Matching placebo for BAY1817080, will be taken twice daily orally as tablet(s)
BAY1817080 will be taken twice daily orally as tablet(s)
Emeritus Research
Botany, New South Wales, Australia
Emeritus Research
Camberwell, Victoria, Australia
Medizinische Universität Graz
Graz, Styria, Austria
Medizinische Universität Innsbruck
Innsbruck, Austria
Afimed s.r.o
Benešov, Czechia
Gynekologie Cheb s.r.o.
Cheb, Czechia
G-Centrum Olomouc s.r.o. Dr. Skrivanek
Olomouc, Czechia
GynCare MUDr. Michael Svec s.r.o.
Pilsen, Czechia
Urocentrum Praha, s.r.o.
Prague, Czechia
Androgeos - private center of urology and andrology
Prague, Czechia
...and 18 more locations
Average change from baseline over Week 4, 8 and 12 (end of treatment [EoT]) in mean number of urgency urinary incontinence (UUI) episodes/24 hours based on electronic bladder diary
Time frame: From baseline up to 12 weeks
Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of UUI episodes/24 hours
Time frame: From baseline up to 12 weeks
Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of urinary incontinence (UI) episodes/24 hours
Time frame: From baseline up to 12 weeks
Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of micturition episodes/24 hours
Time frame: From baseline up to 12 weeks
Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of urgency episodes (Grade 3 or 4)/24 hours
Time frame: From baseline up to 12 weeks
Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean number of nocturia episodes/24 hours
Time frame: From baseline up to 12 weeks
Change from baseline to Week 12 (EoT) based on electronic bladder diary in mean volume voided per micturition
Time frame: From baseline up to 12 weeks
Incidence of adverse events
Time frame: From the start of study intervention (at start of run-in) until the follow-up visit (up to 18 weeks)
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