Ensayos clínicos

 Inclusion Criteria

• Females
• 18 years or older
• No evidence of stress urinary incontinence on physical examination or  previous urodynamics
• Has failed prior drug therapy for overactive bladder or symptoms or has never taken pharmacologic therapy
• Symptoms and signs of OAB, characterized by symptoms of urgency, with or without urge incontinence, usually with frequency and nocturia 
• Is mentally competent with the ability to understand and comply with the requirements of the study
• Agrees to be available for follow-up evaluations as required by the protocol
• Has given signed informed consent

Exclusion Criteria

• Post-Void Residual Urine (PVRU) greater than 100 ml on repeated measures
  • A single PVRU of >100 ml and followed by two consecutive PVRU measurements of <100 ml may be included in the study
• A history of greater than vesicoureteral reflux grade 1, interstitial cystitis, or genitourinary fistulae
• Pelvic organ prolapse stage III or IV, i.e. the most distal part of the prolapse protruding more than 1 cm beyond the hymen (> +1) at straining
• Uninvestigated hematuria
• Lower tract genitourinary malignancies
• On current medication for stress urinary incontinence such as alpha-adrenergic or imipramine prior to initiating study
• Has ongoing complications of prior anti-incontinence surgery
• Is pregnant, lactating, or planning to become pregnant within the study period
• Has received pelvic radiation
• Any condition, which could lead to significant postoperative complications, including current infection and uncontrolled diabetes
• Is morbidly obese (defined as BMI >  40 Kg/m2)
• Is bedridden, institutionalized or in such physical condition that she cannot move to the closest bathroom without assistance from another person
• Has current or acute urinary tract infection, including cystitis or urethritis (such infections should be treated with antibiotics with subsequent urinalysis tests confirming the absence of infection before study inclusion)
• Any condition that would preclude treatment due to contraindications and/or warnings in the study product’s labeling
• On immunomodulatory therapy (suppressive or stimulatory)
• Known lidocaine hypersensitivity or hypersensitivity to any anesthetics
• A concurrent use of another study product within two weeks prior to study start, or concurrently participating in any other clinical study
• Any disease that in the opinion of the Investigator would make the patient unsuitable for the study
• A life expectancy of less than 12 months
• Has received Botox for any other diagnosis within 90 days of study initiation
• Has active neurologic disease