An exploratory, prospective, multicenter, randomized, double blind, placebo + sham device controlled, study to assess the safety, usability, and initial efficacy of the ViXe combination for intravesical administration of XEOMIN® in the treatment of female patients with idiopathic overactive bladder (OAB).

Overactive bladder (OAB)

Safety: Incidence of drug and device related adverse events from treatment to 12-weeks post treatment., Usability: Physician, Subject and Technician’s questionnaires.

Mean change from baseline in the average number of daily Urgency Urinary Incontinence (UUI) Episodes at 6 and 12-weeks post treatment based on a 3-day voiding diary., Mean change from Baseline in the average number of daily voiding episodes at 6 and 12-weeks post treatment based on a 3-day voiding diary., Mean Change from baseline in Urinary grade 3 or 4 Urgency Episodes at 6 and 12-weeks post treatment based on a 3-day voiding diary., Mean change from baseline in Number of large leaks at 6 and 12- weeks post treatment based on a 3-day voiding diary., Change from baseline in QAB-q total score at week 12., Mean change from baseline in the average number of daily Nocturia episodes at 6 and 12-weeks post treatment based on a 3-day voiding diary.

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