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

Completed · Not applicable

Conditions studied: Incontinence

In brief

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.

Key facts

Study ID

NCT01920035

Run by

ZOLL Circulation, Inc., USA

People needed

200

Starts

2013-05-01

Expected to finish

2014-12-01

Last updated by the study team

2020-08-20

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• City Of Hope — Duarte, California, United States
• Swedish Medical Center — Seattle, Washington, United States
• St. Antonius-Hospital Gronau GmbH — Gronau, Germany

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.