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University of California, Irvine |
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Information provided by: | University of California, Irvine |
ClinicalTrials.gov Identifier: | NCT00915031 |
Robotic assisted laparoscopic radical prostatectomy (RLP) has gained widespread acceptance as a standard treatment for clinically localized prostate cancer. Despite the enhanced visualization and precise dissection afforded by the robotic platform, two major comorbidities affect a significant number of men: incontinence and erectile function.
Urinary continence and erectile function
It is commonly believed that the most important factor affecting continence is preservation of the external urinary sphincter complex which lies just below the prostate. Trauma to the urethral tissue itself after it is transected from the prostate and damage to the autonomic nerves that control this sphincter may lead to sphincteric dysfunction. In addition, dissection of the bladder may lead to bladder irritability which also plays a role in incontinence. Surgical removal of the prostate also causes significant inflammatory damage to the pelvic floor which likely delays recovery of urinary continence. The same trauma issues apply to sexual function.
One possible method to protect the nerves and other tissues from operative trauma may be the use of local hypothermia (cold-ischemia) to the pelvis. Local tissue hypothermia using ice, ice slush, or cold irrigation has been safely and routinely used for decades in humans during brain, heart, and kidney surgery to minimize organ damage. Yet, this technique has never been applied to prostate surgery. We will accomplish local cooling of the pelvis using a cooling balloon inserted into the rectum. The cooling balloon is powered by an FDA approved cooling system developed by Innercool therapies. Temperatures of 57-86 degrees F (22+/-8 degrees C).
References
Khan F, Rodriguez E, Finley DS, Skarecky DW, Ahlering TE. Spread of thermal energy and heat sinks:
implications for nerve-sparing robotic prostatectomy. J Endourol. 2007 Oct;21(10):1195-8.
Gill IS, Abreu SC, Desai MM, Steinberg AP, Ramani AP, Ng C, Banks K, Novick AC, Kaouk JH.
Laparoscopic ice slush renal hypothermia for partial nephrectomy: the initial experience.
J Urol. 2003 Jul;170(1):52-6.
Wagner KR, Zuccarello M. Local brain hypothermia for neuroprotection in stroke treatment and aneurysm repair.
Neurol Res. 2005 Apr;27(3):238-45
Condition | Intervention |
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Prostate Cancer |
Device: UroCool |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Historical Control, Parallel Assignment, Efficacy Study |
Official Title: | Hypothermic Nerve Sparing Radical Prostatectomy |
Estimated Enrollment: | 100 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Hypothermia Only OR: Active Comparator
Use of Hypothermia Cooling device only in the operating room
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Device: UroCool
Hypothermia Endorectal Device
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Hypothermia in OR + Recovery: Active Comparator
Use of hypothermia cooling device in the operating room and up to five hours after surgery.
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Device: UroCool
Hypothermia Endorectal Device
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
University of California, Irvine Medical Center | |
Orange, California, United States, 92868 |
Principal Investigator: | Thomas Ahlering, MD | University of California, Irvine |
Responsible Party: | UC Irvine Urology ( Thomas Ahlering, M.D. ) |
Study ID Numbers: | 2008-6397 |
Study First Received: | June 3, 2009 |
Last Updated: | June 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00915031 History of Changes |
Health Authority: | United States: Institutional Review Board |
Robotic prostatectomy Hypothermia Potency |
Hypothermia Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |