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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
Sponsor:
Information provided by (Responsible Party):
Philips Healthcare

Brief 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.

Condition or disease Intervention/treatment Phase
Incontinence Device: UroCool (Local cooling/hypothermia) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
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.
Other Names:
  • Cooling group
  • Hypothermia group
  • Treatment Arm
  • UroCool group

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is male and a candidate for robotic assisted radical prostatectomy (RARP) for the treatment of prostate cancer
  • Patient is over eighteen (>18) years of age
  • Patient reads, understands and speaks English fluently (U.S. Sites only)
  • Subject understands and agrees to all pre-operative preparation procedures including a "self-administered" fleet enema
  • Subject understands study procedures, risks of such procedures and is willing to comply with all study procedures
  • Patient is willing and able to comply with all post-surgical milestones including completing and returning post-surgery follow up questionnaires at specified intervals over a 12 month period
  • Subject agrees to participate in the study and is willing to sign the written informed consent per the enrolling site's institutional procedure

Exclusion Criteria:

  • Presents with baseline or has a history of urinary incontinence
  • Rectal or GI pathology deemed unsuitable for placement of the treatment device by the examining physician
  • Prior extensive pelvic surgery such as low anterior resection, abdominoperineal resection, or proctocolectomy continent stool pouch, or any other extensive abdominopelvic surgery that would render the patient a high-risk for complications as deemed by the surgeon
  • History of prior treatment of any kind for prostate cancer; e.g. radiation therapy, cryotherapy, high-intensity focused ultrasound (HIFU), hormonal or chemotherapy
  • Prior intra-operative injuries (for example: rectal injury)
  • Inadequate hemostasis
  • Serious concurrent medical condition likely to result in death during the next 12 months. Any other acute or chronic condition which the Investigator believes will unacceptably increase the risk of study participation or interfere with study procedures and assessments.
  • Active or recent (within 1 month prior to study enrollment) participation in another investigational clinical research study or planned to be enrolled in another study of prostate therapy.

Information from the National Library of Medicine

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


Locations
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United States, California
City Of Hope
Duarte, California, United States, 91010
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
Germany
St. Antonius-Hospital Gronau GmbH
Gronau, Germany, 48599
Sponsors and Collaborators
Philips Healthcare
Investigators
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Principal Investigator: Thomas Ahlering, MD UC Irvine
Study Director: Anthony M Mullin, MD, MDDR Philips Healthcare/InnerCool BU