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 range
18 Years
Sex
MALE
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.