NCT01920035

Study of Endorectal Cooling During RARP to Minimize Trauma and Promote Earlier Return to Continence

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: ZOLL Circulation, Inc., USA · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Localized cooling/hypothermia using the UroCool System during robotic-assisted radical prostatectomy (RARP) surgery results in an improved overall return to continence, (defined as not wearing any protective urinary pads), compared with standard of care in men presenting for RARP.

Detailed description

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.

Conditions

• Incontinence

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-10-01
• Completion: 2014-12-01
• First posted: 2013-08-09
• Last updated: 2020-08-20

Locations

3 sites across 2 countries: United States, Germany