Comparative Study of the Efficacy and Safety of Muscarinic M3 Receptors Antagonists in the Treatment of Neurogenic Detrusor Overactivity

Inclusion criteria

• Male or female patients, between 18 and 75 years of age. Female patients of childbearing potential* must have a negative urine pregnancy test result on the day of Screening Visit and practice a reliable method of contraception**

*A female is considered of childbearing potential unless she is:

• Postmenopausal for at least 12 months prior to study drug administration;
• Without a uterus and/or both ovaries; or
• Has been surgically sterilized for at least 6 months prior to study drug administration.

**Reliable methods of contraception include:

• Hormonal methods or intrauterine device in use at least 30 days prior to study drug administration;
• Barrier methods plus spermicidal in use at least 14 days prior to study drug administration; or
• Sexual abstinence as a lifestyle.
• Patients with a neurogenic bladder and detrusor overactivity secondary to a spinal cord injury.

• Patients with urinary incontinence (minimum of one occurrence per day) despite current treatment. [NOTE: Bladder emptying may be accomplished with straining, intermittent catheterization (IC), spontaneous micturition or leakage episodes.]
• Patients with serum creatinine within normal limits and normal renal function
• Patients on a stable dose (minimum one month) of concomitant medication for Neurogenic detrusor overactivity
• Patients must have adequate cognitive function to understand the requirements of the study, including completing questionnaires and signing a written Informed Consent.

Exclusion criteria

• Female patients who are pregnant (positive urine pregnancy test), planning to become pregnant during the study period, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
• Patients with a history of transurethral sphincterotomy, bladder neck or prostatic resection, previous bladder surgery including myomectomy or augmentation cystoplasty.
• Patients with chronic indwelling catheters.
• Patients with, in the opinion of the Investigator, unstable or stable multiple sclerosis.
• Patients with known, uncontrolled systemic disease.
• Patients with evidence of recent alcohol/drug abuse.
• Patients with urinary retention, gastrointestinal obstructive disorders or uncontrolled narrow-angle glaucoma.
• Patients with contraindications to Trosec™, Enablex™ and Uromax®.
• Patients who, in the opinion of the Investigator, have a significant condition or situation that may put the patient at significant risk, confound the study results, or interfere significantly with the patient's participation in the study.
• Patients with a history of poor cooperation, non-compliance, or unreliability.
• Patients currently participating in an investigational drug study or who have participated in an investigational drug study within 30 days of the Screening Visit.
• Patients administered anticholinergics and/or antispasmodic drugs during the course of the study.
• Patient with hepatic insufficiency.
• Patient has been administered intravesical botulinum toxin within 6 months prior to the Screening Visit and/or is expected to receive intravesical botulinum toxin during the course of the study.
• Patient has any medical condition that would interfere with the interpretation of the study results or the conduct of the study.