Over Active Bladder Instillation Study - Botox

Inclusion Criteria:

• Female patient aged 18 years or older

• No evidence of stress urinary incontinence on physical examination or urodynamics

• Patients who have failed prior drug therapy for overactive bladder or detrusorhyperreflexia

• Patients with symptoms and signs of OAB, detrusor hyperreflexia, urinary urgency,urinary urge incontinence.

• Patient who is mentally competent with the ability to understand and comply with therequirements of the study

• Patient who agrees to be available for the follow-up evaluations as required by theprotocol

• Patient who has given signed informed consent

Exclusion Criteria:

• Patient with Post-Void Residual Urine (PVRU) greater than 100 ml on repeated measures. (Patient with a single PVRU of >100 ml and followed by two consecutive PVRUmeasurements of <100 ml may be included in the study)

• Patient with greater than vesicoureteral reflux grade 1, interstitial cystitis,genitourinary fistulae

• Patient with pelvic organ prolapse stage III or IV, i.e. the most distal part of theprolapse protruding more than 1 cm beyond the hymen (>+1), at straining

• Patient with un-investigated hematuria

• Patient with lower tract genitourinary malignancies

• Patient on current medication for stress urinary incontinence, such asalpha-adrenergic agonists or duloxetine, within three weeks prior to completing thebaseline Bladder Diary (estrogen therapy on a stable dose for at least two monthsprior to study start is allowed)

• Patient with ongoing complications of prior anti-incontinence surgery

• Patient who is pregnant, lactating, or planning to become pregnant within the studyperiod

• Patient who has received pelvic radiation

• Patient with any condition, which could lead to significant postoperativecomplications, including current infection and uncontrolled diabetes.

• Patient who is morbidly obese (defined as BMI > 40 Kg/m2)

• Patient who is bedridden, institutionalized or in such physical condition that shecannot move to the closest bathroom without assistance from another person

• Patient with current or acute urinary tract infection, including cystitis orurethritis. (Patient with such infections should be treated with antibiotics, withsubsequent urinalysis tests confirming the absence of such infection before studyinclusion)

• Patient with any condition that would preclude treatment due to contraindicationsand/or warnings in the study product's labeling

• Patient on immunomodulatory therapy (suppressive or stimulatory)

• Patient with known lidocaine hypersensitivity or hypersensitivity to any anestheticsto be used during the treatment session/surgical procedure

• Patient with a concurrent use of another study product within two weeks prior to studystart, or who concurrently participate in any other clinical study

• Any disease that in the opinion of the Investigator would make the patient unsuitablefor the study

• Patient with a life expectancy of less than 12 months