Study of Endorectal Cooling During RARP to Minimize Trauma and Promote Earlier Return to Continence

Exclusion Criteria

• •Presents with baseline or has a history of urinary incontinence
• •Rectal or GI pathology deemed unsuitable for placement of the treatment device by the examining physician
• •Prior extensive pelvic surgery such as low anterior resection, abdominoperineal resection, or proctocolectomy continent stool pouch, or any other extensive abdominopelvic surgery that would render the patient a high-risk for complications as deemed by the surgeon
• •History of prior treatment of any kind for prostate cancer; e.g. radiation therapy, cryotherapy, high-intensity focused ultrasound (HIFU), hormonal or chemotherapy
• •Prior intra-operative injuries (for example: rectal injury)
• •Inadequate hemostasis
• •Serious concurrent medical condition likely to result in death during the next 12 months. Any other acute or chronic condition which the Investigator believes will unacceptably increase the risk of study participation or interfere with study procedures and assessments.
• •Active or recent (within 1 month prior to study enrollment) participation in another investigational clinical research study or planned to be enrolled in another study of prostate therapy.