Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Symptoms and General Pathology

Prostatic Neoplasms

Erectile Dysfunction

Hypothermia

Urinary Incontinence

Enuresis

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Urination Disorders

Urologic Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Lower Urinary Tract Symptoms

Urological Manifestations

Mental Disorders

Psychotic Disorders

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

Body Temperature Changes

After Subjects arrive at the MRI facility, subjects will fill out a medical questionnaire that will be used to determine whether a MRI study can be performed. The investigators will determine whether there are any problems that make the subject not suitable for participating in this study.

Thomas E Ahlering, MD

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 cooling of the prostate and its direct translation into improved continence and sexual function after surgery. The purpose of this research study is to use Magnetic Resonance Imaging (MRI) and Thermal MRI with subjects who will receive the investigational endorectal cooling balloon to help further understand how the cooling balloon works, which may translate to other uses in the future, including the diagnosis of patients at a high risk of developing prostate cancer.

Prostate cancer is the second most frequent cause of cancer death in men and it accounts for 11% of all male cancers. Radical prostatectomy remains the gold standard for localized disease, offering the advantage of precise staging and grading and the real possibility of disease eradication. In the US there are approximately 100,000 radical prostatectomies (RP) performed for prostate cancer annually. However, there are two major challenges to the quality of life outcomes after radical prostatectomy: preserving urinary continence, and sexual function. The quality of life (QOL) after radical prostatectomy relies on the return of continence and sexual function after surgery to their pre-operative 'normal' status. The main factor which determines potency rates for patients is whether or not the nerves at the Neurovascular Bundles (NVB), are spared, and it may take years for sexual function to return. This may be due to the nerve injury from the nerve trauma in the surgical procedure. Similarly, a major factor involved in post-radical prostatectomy incontinence is preservation of the nerves that control the external urethral sphincter, bladder, and urogenital diaphragm. Also Inflammation from surgical removal of the prostate not only affects nerves, but also may directly damage the bladder, urethra, and pelvic floor. Effective strategies to prevent this damage are currently lacking. One stratagem to prevent or minimize such damage, is the use of local hypothermia with ice or cold irrigation around the nerves and tissues prior to, during, and after the injury has occurred. In numerous experimental models of central and peripheral nervous system injury, the use of moderate hypothermia (i.e. 28-33oC) has been shown to provide dramatic neuroprotection safely in humans, during cardiac, kidney, and brain surgery for many years.

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

MRI (Magnetic Resonance Imaging) Temperature Mapping of the Prostate and Urogenital Pelvis Cooled by an Endorectal Balloon

During pre and post hypothermia, initial temperatures will be measured simultaneously on five 3-mm-thick image slices that covered the target. The thermometry scan can be repeated every 6 s. Tissue temperature map is measured by magnetic resonance thermometry (echo planar imaging with multiphase; field of view: 25 × 25 cm; matrix 256 × 256; number of excitations: 1; repetition time: 545 ms; echo time: 20 ms; flip angle: 20°; slice thickness: 3 mm); (b) a thermal map of the tissue volume will be superimposed on the anatomical image.

Before the subject's scheduled radical prostatectomy surgery, they will have an MRI combined with an cooling endorectal balloon (this study), which will 1. Show the dimensions of their lower pelvis, including the prostate, and 2.Measure how cold the tissue around the prostate becomes using the cooling balloon. The thermal MRI images will allow elucidation of temperatures at specified anatomic locations and their changes over time. Data will be described using means for normally distributed continuous variables. We will test for associations between temperature and continence using t-tests to compare temperature change between those who achieve continence at 30 and 60 days and those who do not.

University of California, Irvine

Vice Chairman and Urology Professor

Spots Global Cancer Trial Database for continence outcomes