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

Incontinence Clinical Trial

— UroCool  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01920035
• Other study ID #: IT 04-200
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: December 2014

Study information

• Verified date: November 2014
• Source: ZOLL Circulation, Inc., USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Incontinence

Intervention

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.

Locations

Country	Name	City	State
Germany	St. Antonius-Hospital Gronau GmbH	Gronau
United States	City Of Hope	Duarte	California
United States	Swedish Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
ZOLL Circulation, Inc., USA

Countries where clinical trial is conducted

United States,  Germany, 

References & Publications (2)

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. Erratum in: J Endourol. 2010 Sep;24(9):1541. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reduction of overall severe incontinence	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.	90 days, 6 months and 12 months
Primary	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	Faster return to continence.	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.	30, 60 and 90 days

External Links

•   Thomas .E. Ahlering, MD - department of Urology