IncontinenceUroCoolNCT01920035
Study of Endorectal Cooling During RARP to Minimize Trauma and Promote Earlier Return to Continence
A study testing UroCool (Local cooling/hypothermia) in people with Incontinence, run by ZOLL Circulation, Inc., USA at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Incontinence
- What is being tested?
- UroCool (Local cooling/hypothermia)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesin 2 countries
- Study dates
- May 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
City Of Hope
Duarte, California, 91010
Swedish Medical Center
Seattle, Washington, 98122
About this study
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
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.
Read the 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
- Being tested
- UroCool (Local cooling/hypothermia)
- Keywords
- Incontinence post RARP, Surgery induced incontinence, Incontinence after prostatectomy, Neuropathy-induced incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UroCool (Local cooling/hypothermia)Device
Also called Cooling group, Hypothermia group, Treatment Arm, UroCool group
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days post RARP
Secondary outcomes (1)
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.
Measured: 30, 60 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZOLL Circulation, Inc., USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Ahlering, MD, Principal investigator, UC IrvineAnthony M Mullin, MD, MDDR, Study director, Philips Healthcare/InnerCool BU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920035
- Sponsor's protocol ID
- IT 04-200
- Acronym
- UroCool
- Status last verified
- Nov 2014
- First submitted
- 7 Aug 2013
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23153199Finley 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.
PubMed 20624082Huynh 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.
PubMed 30397236
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01920035
- Acronym / sponsor ID
- UroCool / IT 04-200
- Conditions
- Incontinence
- Keywords
- Incontinence post RARP, Surgery induced incontinence, Incontinence after prostatectomy, Neuropathy-induced incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- ZOLL Circulation, Inc., USAIndustry (pharma, biotech, devices)
- Study start
- May 2013 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local cooling/hypothermia | Experimental | Device: UroCool (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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UroCool (Local cooling/hypothermia)Also: Cooling group, Hypothermia group, Treatment Arm, UroCool groupThese 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. | Device | Local cooling/hypothermia |
Primary outcome
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.
1 secondary outcome
Faster return to continence.
Time frame: 30, 60 and 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- Background: PubMed 23153199Liss 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.
- Background: PubMed 20624082Finley 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.
- Derived from this study: PubMed 30397236Huynh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Ahlering, MD principal investigator
UC Irvine
Anthony M Mullin, MD, MDDR study director
Philips Healthcare/InnerCool BU
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UroCool (Local cooling/hypothermia) in people with Incontinence, run by ZOLL Circulation, Inc., USA at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved return of overall continence. (time frame: 90 days post RARP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01920035, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2020.