Safety and Efficacy of SAF312 in Patients With Neurogenic Detrusor Overactivity Due to Spinal Cord Lesions

A Multi-center, Double-blind, Randomized, Placebo-controlled, Cross-over Study to Evaluate the Efficacy, Safety and Tolerability of SAF312 in Subjects With Neurogenic Detrusor Overactivity Due to Spinal Cord Lesions Who Are Inadequately Managed by Antimuscarinic Therapy

This study will assess the safety, tolerability and efficacy of SAF312 in patients with overactive bladder disease due to spinal cord lesions. The overactive bladder of patients who qualify for this study is insufficiently managed by antimuscarinic therapy, or patients poorly tolerate the treatment with antimuscarinic drugs. The efficacy of SAF312 will be primarily determined via urodynamic measurements.

Inclusion Criteria:

• Patients with neurogenic detrusor overactivity due to spinal cord lesions
• Patients are inadequately managed by antimuscarinic medication and present with a cystometric bladder capacity of max. 400 mL

Exclusion Criteria:

• Chronic inflammation such as interstitial cystitis, bladder stones, hematuria of unknown origin, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
• Pelvic or genitourinary tract anomalies including surgery or bladder disease other than detrusor overactivity impacting on bladder function