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MRI Temperature Mapping of the Prostate and Urogenital Pelvis Cooled by an Endorectal Balloon

NCT01979848 · University of California, Irvine · Updated 13 Dec 2016

What is being tested
Not stated
For
Prostate Cancer; Hypothermia; Urinary Incontinence; Erectile Dysfunction
Kind of study
Watches patients without assigning a treatment. No drug phase (a device or procedure study).
Who can join
Ages 21 years and older. About 3 people. The full rules are on the registry page.
Where
United States
When
Starts or started June 2013, ends Nov 2015. Registered 8 Nov 2013.
Results
None posted yet.

In the researchers' words

Urinary incontinence and sexual dysfunction are potential side effects for men undergoing the successful removal of the cancerous prostate via surgery. Hypothermic cooling via the investigational Endorectal Cooling Balloon has been shown by our group to significantly reduce long term urinary incontinence and may reduce sexual dysfunction in men after robotic prostatectomy, and improve the patient's long term quality of life (QOL). However before successful translation of the endorectal balloon can proceed into the world wide usage, we must understand: 1. How effectively the tissues for continence and sexual function are cooled within the pelvis. 2. What is the capacity of vascularized structures (i.e. the neurovascular bundle) to 'cool sink' or diminish the effective cooling and 3. Determine if the endorectal balloon can be re-designed for improved QOL outcomes in men. This research study marries two new techniques of Thermal MRI imaging and Endorectal cooling for prostate cancer surgery. MRI is non-invasive. A simple confirmation of effective hypothermic cooling can be achieved by novel MRI thermal mapping of the cooling gradient as it comprehensively sweeps through the rectum across the urogenital pelvis. MRI with temperature adaptive software can accurately map these gradients with non-invasive technique, and answer formidable questions of the effectiveness of hypothermic…
ClinicalTrials.gov, NCT01979848

Sites

  • University of California, Irvine Medical CenterOrange, California, United States