Study of Endorectal Cooling During RARP to Minimize Trauma and Promote Earlier Return to Continence (UroCool)
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|ClinicalTrials.gov Identifier: NCT01920035|
Recruitment Status : Unknown
Verified November 2014 by Philips Healthcare.
Recruitment status was: Active, not recruiting
First Posted : August 9, 2013
Last Update Posted : November 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Incontinence||Device: UroCool (Local cooling/hypothermia)||Not Applicable|
This study will assess the use of an endorectal cooling device, UroCool, to achieve controlled, local hypothermia of the pelvis. The study will evaluate the safety and effectiveness of the device in inducing hypothermia of the neuromuscular tissues impacting continence during RARP.
The UroCool system is designed to apply targeted temperature control to the pelvic anatomy during RARP. The pelvis is cooled transrectally via a closed cycle recirculation of chilled sterile saline using a single-use disposable balloon catheter connected via a circulation IV set to a control console that is covered by a current 510(k) and commercially available.
The UroCool polymeric catheter is designed to be inserted within the rectal cavity adjacent to the prostate prior to surgery and removed upon completion of surgery. It is used in conjunction with the InnerCool Console which circulates cold saline in a closed loop within the UroCool catheter to allow for therapeutic localized cooling of the prostate gland and surrounding areas during prostate surgery.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Randomized, Controlled Study of the Use of Localized Endorectal Cooling Using the UroCool System During Robotic-Assisted Radical Prostatectomy (RARP) to Minimize Trauma and to Provide Earlier Return to Continence|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||October 2014|
|Estimated Study Completion Date :||December 2014|
Experimental: Local cooling/hypothermia
These patients will have the UroCool device inserted prior to RARP to induce localized cooling/hypothermia of the pelvic region prior to and during RARP surgery.
Device: UroCool (Local cooling/hypothermia)
These patients will receive the UroCool device which will be inserted just prior to RARP surgery. The UroCool device will be used to effect localized cooling/hypothermia of the pelvic region prior to and during RARP surgery. It will be removed at the end of surgery.
No Intervention: Control Group: RARP without hypothermia
These patients will receive standard of care only for RARP surgery. They will not receive the UroCool investigational device.
- Improved return of overall continence. [ Time Frame: 90 days post RARP ]The primary objective of the study is an improved return of overall continence measured at 90 days post RARP surgery. A favorable outcome would be improved overall continence in the RARP with hypothermia group versus the RARP without hypothermia group.
- Faster return to continence. [ Time Frame: 30, 60 and 90 days ]The secondary objective of the study is to see if men will achieve a return to continence faster if treated with hypothermia. This will be assessed at 30, 60 and 90 days. A favorable outcome would be a reduced time to continence in the RARP with hypothermia group versus the RARP without hypothermia group.
- Reduction of overall severe incontinence [ Time Frame: 90 days, 6 months and 12 months ]The third objective is to assess reduction of overall severe incontinence. Severe incontinence is defined as the need for 3 or more pads in a 24 hour period. This will be assessed at 90 days, 6 and 12 months. A favorable outcome would be a reduction of overall severe incontinence in the RARP with hypothermia group versus the RARP without hypothermia group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920035
|United States, California|
|City Of Hope|
|Duarte, California, United States, 91010|
|United States, Washington|
|Swedish Medical Center|
|Seattle, Washington, United States, 98122|
|St. Antonius-Hospital Gronau GmbH|
|Gronau, Germany, 48599|
|Principal Investigator:||Thomas Ahlering, MD||UC Irvine|
|Study Director:||Anthony M Mullin, MD, MDDR||Philips Healthcare/InnerCool BU|