Clinical trial NCT01920035: Study of Endorectal Cooling During RARP to Minimize Trauma and Promote Earlier Return to Continence
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incontinence
Keywords: Incontinence post RARP
Surgery induced incontinence
Incontinence after prostatectomy
Neuropathy-induced incontinence
Lead sponsor: ZOLL Circulation, Inc., USA
Sponsor class: INDUSTRY
First posted: 2013-08-09
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Improved return of overall continence.
timeFrame: 90 days post RARP
Secondary outcomes:
measure: Faster return to continence.
timeFrame: 30, 60 and 90 days
Other outcomes:
measure: Reduction of overall severe incontinence
timeFrame: 90 days, 6 months and 12 months
Locations:
city: Duarte
country: United States
facility: City Of Hope
state: California
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Gronau
country: Germany
facility: St. Antonius-Hospital Gronau GmbH
Study officials:
affiliation: UC Irvine
name: Thomas Ahlering, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Philips Healthcare/InnerCool BU
name: Anthony M Mullin, MD, MDDR
role: STUDY_DIRECTOR
References:
citation: Liss MA, Skarecky D, Morales B, Ahlering TE. The application of regional hypothermia using transrectal cooling during radical prostatectomy: mitigation of surgical inflammatory damage to preserve continence. J Endourol. 2012 Dec;26(12):1553-7. doi: 10.1089/end.2012.0345. Epub 2012 Nov 15.
citation: Finley DS, Chang A, Morales B, Osann K, Skarecky D, Ahlering T. Impact of regional hypothermia on urinary continence and potency after robot-assisted radical prostatectomy. J Endourol. 2010 Jul;24(7):1111-6. doi: 10.1089/end.2010.0122.
citation: Huynh LM, Skarecky D, Porter J, Wagner C, Witt J, Wilson T, Lau C, Ahlering TE. A Randomized Control Trial Of Anti-Inflammatory Regional Hypothermia On Urinary Continence During Robot-Assisted Radical Prostatectomy. Sci Rep. 2018 Nov 5;8(1):16352. doi: 10.1038/s41598-018-34657-4.