CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 738 enrolled
Drug / intervention
UroCooldevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00915031
NCT00915031N/ACompleted

Hypothermic Nerve Sparing Radical Prostatectomy

University of California, Irvine·interventional·Posted Jun 5, 2009·Updated Mar 27, 2019

In Brief

A clinical study evaluating UroCool for Prostate Cancer. Completed, enrolled 738 participants across 1 site.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 5, 2009
Enrollment StartAug 1, 2009
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 17.1 years ago

Interventions

UroCooldevice

Hypothermia Endorectal Device