The Effect of Oxymetazoline Gel on Anal Pressure and Incontinence in Spinal Cord Injury Patients

Inclusion criteria

• Signed written informed consent.
• Male or female subjects 18 to 55 years of age;
• Spinal Cord Injury that occurred at least 3 months from randomization day and less than 3 years from randomization day.
• At least 4 unwanted/unexpected incontinent events/week

Exclusion criteria

• Known allergy to Oxymetazoline or silicone.
• Pregnancy or lactation.
• Active cardiovascular or cerebrovascular disease including unstable angina, myocardial infarction, transient ischemic attacks/stroke, clinically significant arrhythmia, congestive heart failure, or cardiac valve abnormalities;
• Type 1 diabetes mellitus;
• Insulin treated type 2 diabetes mellitus;
• Renal insufficiency.
• Liver insufficiency.
• Malignant disease within 5 years of screening;
• History of rectal surgery.
• History of HIV, hepatitis B, hepatitis C.
• Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula, infection or space occupying lesion.
• Has used, in the last 1 week, drugs that may affect blood coagulation, such as Aspirin (at a dose above 500 mg/day), Warfarin, Sintrom, Enoxaparin, Nadroparin, Heparin, Clopidogrel, Ticlopidine.
• Hypertension (blood pressure over 150/105 mm Hg in screening visit)
• Unable to understand the use instruction, as judged by the investigator.