Prostate CancerNCT02108431
Prospective Randomized Trial Comparing Urinary Diversion After Robot-assisted Radical Prostatectomy
A study testing balloon catheter for suprapubic bladder-drainage and balloon catheter for transurethral bladder-drainage in people with Prostate Cancer, run by St. Antonius Hospital Gronau at 1 site in Germany.
Trial summary
The purpose of the study is to determine, whether the urinary diversion via suprapubic cystostomy compared to transurethral catheterization after robot-assisted radical prostatectomy superior the postoperative patient comfort and reduce the postoperative bacteriuria. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- balloon catheter for suprapubic bladder-drainage and balloon catheter for transurethral bladder-drainage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2013to Nov 2013
- 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
- Minimum age of 18 Years
- Voluntarily agreement to participate in this study
- Written informed-consent
- Release of medical records for regulatory or research purposes
- Clinically organ-confined prostate cancer
Who cannot join
- BMI >40
- History of catheterization
- History of radiation
- History of chemotherapy
- Person's participating in any other research
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Urology, Pediatric Urology and Urologic Oncology; St. Antonius-Hospital Gronau GmbH
Gronau, 48599
About this study
Official title: Superior Postoperative Patient Comfort in Suprapubic Drainage Versus Transurethral Catheterization Following Robot-assisted Radical Prostatectomy: A Prospective Randomized Clinical Trial
The purpose of the study is to determine, whether the urinary diversion via suprapubic cystostomy compared to transurethral catheterization after robot-assisted radical prostatectomy superior the postoperative patient comfort and reduce the postoperative bacteriuria.
- Conditions
- Prostate Cancer
- Being tested
- balloon catheter for suprapubic bladder-drainage, balloon catheter for transurethral bladder-drainage
- Keywords
- urinary diversion, urethral catheter, suprapubic tube, radical prostatectomy, robotic surgery, discomfort, pain
- Medical subject headings
- Prostatic Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balloon catheter for suprapubic bladder-drainageDevice
Also called UROMED, suprapubic tube, suprapubic device
suprapubic tube removal was allowed when the anastomosis was watertight, Day 5
balloon catheter for transurethral bladder-drainageDevice
Also called UROMED
transurethral catheter withdrawal was allowed when the anastomosis was watertight, Day 5
| Study group | Role | What they receive |
|---|---|---|
| balloon catheter for transurethral bladder-drainage | Experimental | intraoperatively placement of transurethral catheter after robot-assisted radical prostatectomy Receives: Device: balloon catheter for transurethral bladder-drainage |
| balloon catheter for suprapubic bladder-drainage | Active comparator | intraoperatively placement of suprapubic catheter after robot-assisted radical prostatectomy Receives: Device: balloon catheter for suprapubic bladder-drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of postoperative pain related to urinary drainage objectified by numeric rating scale (NRS) questionnaire within 5 days
To analyse the development of the postoperative pain related to urinary drainage patients completed NRS questionnaire three times a day: in the morning, at noon and in the evening until discharge of the catheter (regular 5 days after the surgery)
Measured: postoperatively on day 1, 2, 3, 4 and 5 in the morning, at noon and in the evening
Secondary outcomes (1)
Number of patients with bacteriuria
Second void urine sample after catheter removal
Measured: 5th day after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startFeb 2013
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital Gronau
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.H. Witt, St. Antonius Hospital Gronau
- Investigators
- Jawid Habibzada, MD., Study chair, St. Antonius Hospital GronauMichael Godes, MD., Study chair, St. Antonius Hospital Gronau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108431
- Sponsor's protocol ID
- U1111-1155-1458
- Status last verified
- Apr 2014
- First submitted
- 31 Mar 2014
- Last updated
- 9 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superior Postoperative Patient Comfort in Suprapubic Drainage Versus Transurethral Catheterization Following Robot-assisted Radical Prostatectomy: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02108431
- Acronym / sponsor ID
- U1111-1155-1458
- Conditions
- Prostate Cancer
- Keywords
- urinary diversion, urethral catheter, suprapubic tube, radical prostatectomy, robotic surgery, discomfort, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- St. Antonius Hospital GronauUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 9 Apr 2014 (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.
The purpose of the study is to determine, whether the urinary diversion via suprapubic cystostomy compared to transurethral catheterization after robot-assisted radical prostatectomy superior the postoperative patient comfort and reduce the postoperative bacteriuria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| balloon catheter for transurethral bladder-drainage | Experimental | Device: balloon catheter for transurethral bladder-drainageintraoperatively placement of transurethral catheter after robot-assisted radical prostatectomy |
| balloon catheter for suprapubic bladder-drainage | Active comparator | Device: balloon catheter for suprapubic bladder-drainageintraoperatively placement of suprapubic catheter after robot-assisted radical prostatectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Minimum age of 18 Years
- Voluntarily agreement to participate in this study
- Written informed-consent
- Release of medical records for regulatory or research purposes
- Clinically organ-confined prostate cancer
Key exclusion criteria (6 listed)
- BMI >40
- History of catheterization
- History of radiation
- History of chemotherapy
- Person's participating in any other research
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 |
|---|---|---|
| balloon catheter for suprapubic bladder-drainageAlso: UROMED, suprapubic tube, suprapubic devicesuprapubic tube removal was allowed when the anastomosis was watertight, Day 5 | Device | balloon catheter for suprapubic bladder-drainage |
| balloon catheter for transurethral bladder-drainageAlso: UROMEDtransurethral catheter withdrawal was allowed when the anastomosis was watertight, Day 5 | Device | balloon catheter for transurethral bladder-drainage |
Primary outcome
Change of postoperative pain related to urinary drainage objectified by numeric rating scale (NRS) questionnaire within 5 days
Time frame: postoperatively on day 1, 2, 3, 4 and 5 in the morning, at noon and in the evening
To analyse the development of the postoperative pain related to urinary drainage patients completed NRS questionnaire three times a day: in the morning, at noon and in the evening until discharge of the catheter (regular 5 days after the surgery)
1 secondary outcome
Number of patients with bacteriuria
Time frame: 5th day after the surgery
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 9 Apr 2014.
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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.
Jawid Habibzada, MD. study chair
St. Antonius Hospital Gronau
Michael Godes, MD. study chair
St. Antonius Hospital Gronau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing balloon catheter for suprapubic bladder-drainage and balloon catheter for transurethral bladder-drainage in people with Prostate Cancer, run by St. Antonius Hospital Gronau at 1 site in Germany.
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 5 inclusion and 6 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 9 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Change of postoperative pain related to urinary drainage objectified by numeric rating scale (NRS) questionnaire within 5 days (time frame: postoperatively on day 1, 2, 3, 4 and 5 in the morning, at noon and in the evening). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2014.