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

NCT01920035 | Completed DMC

• 1 other identifier: IT 04-200
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 3

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.

Conditions

Incontinence

Keywords

Incontinence post RARP; Surgery induced incontinence; Incontinence after prostatectomy; Neuropathy-induced incontinence

Outcome Measures

Primary Outcomes (1)

• Improved return of overall continence.

  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.

  90 days post RARP

Secondary Outcomes (1)

• Faster return to continence.

  30, 60 and 90 days

Other Outcomes (1)

• Reduction of overall severe incontinence

  90 days, 6 months and 12 months

Study Arms (2)

Local cooling/hypothermia

EXPERIMENTAL

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)

Control Group: RARP without hypothermia

NO INTERVENTION

These patients will receive standard of care only for RARP surgery. They will not receive the UroCool investigational device.

Interventions

UroCool (Local cooling/hypothermia) DEVICE

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.

Also known as: Cooling group, Hypothermia group, Treatment Arm, UroCool group

Local cooling/hypothermia

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ZOLL Circulation, Inc., USA: lead

Study Sites (3)

City Of Hope

Duarte, California, 91010, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

St. Antonius-Hospital Gronau GmbH

Gronau, 48599, Germany

Location

Related Publications (3)

• 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.

  PMID: 23153199 BACKGROUND

• 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.

  PMID: 20624082 BACKGROUND

• 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.

  PMID: 30397236 DERIVED

Study Officials

• Thomas Ahlering, MD

  UC Irvine

  PRINCIPAL INVESTIGATOR

• Anthony M Mullin, MD, MDDR

  Philips Healthcare/InnerCool BU

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2013
• First Posted: August 9, 2013
• Study Start: May 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 20, 2020

Record last verified: 2014-11

Locations

DE (1); US (2)