N/A
N=738
Use of Hypothermia During Robotic Prostatectomy
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00915031 ↗Enrolled (actual)
738
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Feasibility and Safety Using an Improved, More Efficient and Less Labor Intensive Cooling Balloon in Patients Undergoing Hypothermic Nerve-sparing RLP in Participants Determined by Return to Continence — 714; 24 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- UroCool (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of California, Irvine
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility and Safety Using an Improved, More Efficient and Less Labor Intensive Cooling Balloon in Patients Undergoing Hypothermic Nerve-sparing RLP in Participants Determined by Return to Continence |
714; 24 | — |
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).
Eligibility Criteria
Inclusion Criteria
- adult males
- receiving robotic radical prostatectomy for the treatment of prostate cancer
Exclusion Criteria
- previous radiation
- previous cryotherapy
Data sourced from ClinicalTrials.gov (NCT00915031). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.