Study of Endorectal Cooling During RARP to Minimize Trauma and Promote Earlier Return to Continence (NCT01920035) | Clinical Trial Compass
CompletedNot Applicable
Study of Endorectal Cooling During RARP to Minimize Trauma and Promote Earlier Return to Continence
United States, Germany200 participantsStarted 2013-05
Plain-language summary
Localized cooling/hypothermia using the UroCool System during robotic-assisted radical prostatectomy (RARP) surgery results in an improved overall return to continence, (defined as not wearing any protective urinary pads), compared with standard of care in men presenting for RARP.
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient is male and a candidate for robotic assisted radical prostatectomy (RARP) for the treatment of prostate cancer
* Patient is over eighteen (\>18) years of age
* Patient reads, understands and speaks English fluently (U.S. Sites only)
* Subject understands and agrees to all pre-operative preparation procedures including a "self-administered" fleet enema
* Subject understands study procedures, risks of such procedures and is willing to comply with all study procedures
* Patient is willing and able to comply with all post-surgical milestones including completing and returning post-surgery follow up questionnaires at specified intervals over a 12 month period
* Subject agrees to participate in the study and is willing to sign the written informed consent per the enrolling site's institutional procedure
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…