Safety and Efficacy Study of Intravesical Instillations of BotuGelTM, Slow Release RTGel Based Botox® Formulations, in Idiopathic OAB Patients With Urinary Incontinence ("INTIMO2")
Safety and Efficacy Study of Intravesical Instillations of BotuGelTM, Slow Release RTGel Based Botox® Formulations, in Idiopathic OAB Patients With Urinary Incontinence ("INTIMO2")
The study will investigate the safety and efficacy of UroGen's TC-3 Gel for sustained release
 of Botulinum Toxin A (BTX) in urinary bladder in patients with idiopathic overactive bladder.
Overactive bladder (OAB) is a syndrome, defined by the International Continence Society
 (ICS), as the presence of "urinary urgency, usually accompanied by frequency and nocturia,
 with or without urgency urinary incontinence, in the absence of a urinary tract infection
 (UTI) or other obvious pathology." This study will evaluate a new of mode of treatment, with
 intravesical bladder instillation with Botox® mixed with TC-3 that may bypass the drawbacks
 of the current bladder injection treatment mode in OAB patients. Additionally it will provide
 preliminary safety and efficacy data that may serve as a basis for a larger study exploring
 safety and efficacy aspects of this new mode of treatment.

 50 patients will be randomized in a horse race fashion in a ~2:2:1 ratio. The patients will
 be screened for up to 3 weeks prior to treatment.

 The patients will be requested to stop their OAB medications 7 days prior to treatment visit.
 20 patients will receive one instillation of 300U of BotuGel (60ml), 20 patients will receive
 one instillation of 400U of BotuGel (60ml) and 10 patients will receive one instillation of
 60 ml RTGel-TC-3 Gel (Placebo), all patients will be followed up for safety and efficacy
 endpoints until 6 weeks post instillation.
Main Inclusion Criteria:

 -  Female patient 18 to 75 years old diagnosed with idiopathic OAB.

 -  Patient has symptoms of OAB for ≥ 3 months prior to screening.

 -  Patient is a non-responder to pharmacologic therapy or has intolerable side effects or
 is not compliant to the treatment.

 -  On screening three-day voiding diary- Patient has a frequency of at least 8
 micturitions per 24 hours & Total of ≥3 urgency urinary incontinence (UUI) episodes.

 -  Patient is willing and able to initiate self catheterization post-treatment, if
 required.

 -  Patients has PVR ≤100 ml. Patient with a single PVR of >100 ml and followed by two
 consecutive PVR measurements of <100 ml may be included in the study).

 Main Exclusion Criteria:

 -  Patient currently uses CIC or indwelling catheter to manage their urinary incontinence

 -  Patient who has clinically significant Bladder Outlet Obstruction (BOO).

 -  Patient with active urinary tract infection.

 -  OAB due to any known neurological reason.

 -  Patient with 24-hour total urine volume voided greater than 3,000 ml as measured at
 screening visit.

 -  Predominance of stress incontinence in the opinion of the investigator, determined by
 patient history.

 -  Use of anticholinergics or other medications or therapies to treat symptoms of OAB
 within 7 days of screening.

 -  Patient with prior botulinum toxin therapy of any serotype within 12 weeks for any
 indication.

 -  Patient with prior use of Botulinum toxin therapy of any serotype for any urological
 condition.

 -  Patient with previous pelvic radiation therapy.

 -  Patient had been treated for two or more UTIs within last 6 months or use of
 prophylactic antibiotics to prevent chronic UTIs.

 -  ANY condition identified which may cause overactive bladder symptoms