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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
One intravesical instillation of 300 IU of botox in 60 ml of TC-3 gel
One intravesical instillation of 400 IU of botox in 60 ml of TC-3 gel
Intravesical instillation of 60 ml TC-3 gel
Rambam Health Care Campus
Haifa, Israel
Meir Medical Center
Kfar Saba, Israel
Urinary retention
Urinary retention events defined as a PVR \>200 and \<350 ml with patient reported symptoms that in the investigator's opinion require initiation of CIC, or PVR≥350 regardless of symptoms.
Time frame: 6 weeks
Urinary tract infection (UTI) events
Urinary tract infection (UTI) events\* \*Asymptomatic bacteruria will not be considered UTI and will be reported as separate AEs.
Time frame: 6 weeks
Post-void residual (PVR)
PVR-Change from baseline in PVR as measured by bladder ultrasonography at week 4 post instillation
Time frame: 6 weeks
Adverse events
Adverse events during and post instillation procedure.
Time frame: 6 weeks
3-day voiding Diary
3-day voiding Diary * Change from baseline in number of Urgency episodes and Urinary Incontinence episodes/24h * Change from baseline in number of voids/24h * Change from baseline in number of nocturnal voids per night (Based on individual patient's night and day hours) * Change from baseline in Mean volume voided per micturition/24h
Time frame: Week 4 and 6 post-instillation
Kings Health Questionnaire (KHQ score) comparing to baseline
KHQ score comparing to baseline
Time frame: Week 4 and 6 post-instillation
Incontinence Quality of Life Questionnaire (I-QOL)
I-QOL score comparing to baseline
Time frame: Week 4 and 6 post-instillation
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Treatment Benefit Scale (TBS)
Proportion of patients who had positive treatment response per Treatment Benefit Scale (TBS)
Time frame: Week 4 and 6 post-instillation
Comparison of resulted delta scores between the treatment arms and Placebo
Time frame: Week 4 and 6 post-instillation