Finished
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…
Sites
- University of California, Irvine Medical CenterOrange, California, United States
