Prostate CancerMPHNCT02812173
Postoperative Patient Comfort and Quality of Micturition in Suprapubic Tube vs. Transurethral Catheterization After RARP
A study testing suprapubic tube ex 2 day, suprapubic tube ex 5 day and transurethral catheter ex 5 day 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 postoperative quality of micturition and continence can be improved depending on the urinary drainage catheter and retention after robot assisted radical prostatectomy. 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?
- suprapubic tube ex 2 day, suprapubic tube ex 5 day and transurethral catheter ex 5 day
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteGermany
- Study dates
- May 2016to Jun 2018
- 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
- filled in and signed Informed Consent
- release of medical records for regulatory or research purposes
- clinically organ-confined prostate cancer
- recommended and planned robot-assisted radical prostatectomy
Who cannot join
- Participation in other interventional trials that could interfere with the present study
- International Prostate Symptom Score (IPPS) > 18
- History of radiation or chemotherapy
- History of transurethral prostate resection
- unable to provide informed consent
- unwillingness to storage and forwarding of pseudonymous data
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Urology, Pediatric Urology and Urologic Oncology, St. Antonius Hospital Gronau
Gronau, 48599
About this study
Official title: Prospective, Randomized, Three-arm, Open Controlled Trial Comparing the Quality of Micturition and the Patient Comfort by Various Urinary Drainage After Robot-assisted Radical Prostatectomy (RARP)
The purpose of the study is to determine, whether the postoperative quality of micturition and continence can be improved depending on the urinary drainage catheter and retention after robot assisted radical prostatectomy. Another finding could be the study of the pain assessment of the patient, as well as the pain medication at the various derivatives. Further check whether infections and the presence of bacteriuria can be reduced or avoided by the form of urinary drainage.
- Conditions
- Prostate Cancer
- Being tested
- suprapubic tube ex 2 day, suprapubic tube ex 5 day, transurethral catheter ex 5 day
- Keywords
- urinary drainage, urethral catheter, suprapubic tube, pain, discomfort, radical prostatectomy, robotic surgery, urinary infection
- Medical subject headings
- Prostatic Neoplasms, Pain, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suprapubic tube ex 2 dayDevice
Also called Uromed
balloon catheter for suprapubic bladder-drainage, suprapubic tube removal on the second day after the surgery
suprapubic tube ex 5 dayDevice
Also called Uromed
balloon catheter for suprapubic bladder-drainage, suprapubic tube removal on the fifth day after the surgery
transurethral catheter ex 5 dayDevice
Also called Uromed
transurethral catheter withdrawal removal on the fifth day after the surgery
| Study group | Role | What they receive |
|---|---|---|
| suprapubic tube ex 2 day | Active comparator | patients who underwent robot-assisted radical prostatectomy and got intraoperatively, a suprapubic tube, which was withdrawn on the 2th day after the surgery Receives: Device: suprapubic tube ex 2 day |
| suprapubic tube ex 5 day | Active comparator | patients who underwent robot-assisted radical prostatectomy and got intraoperatively, a suprapubic tube, which was withdrawn on the 5th day after the surgery Receives: Device: suprapubic tube ex 5 day |
| transurethral catheter ex 5 day | Active comparator | patients who underwent robot-assisted radical prostatectomy and got intraoperatively, a transurethral catheter, which was withdrawn on the 5th day after the surgery Receives: Device: transurethral catheter ex 5 day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary leakage measured by pad test in grams
Measured: within the day 2 or day 5 after the surgery for 24 hours
Secondary outcomes (4)
Detection of postoperative pain related to urinary drainage by numeric rating scale (NRS)
Measured: once a day, first 7 days after the surgery
Recording of complications
Measured: within the 4 weeks after surgery
Urine status measured by flow cytometry
Measured: within the day 2 or day 5 after the surgery
Residual urine measured by bladder scan in ml
Measured: 3 times within the day 2 or day 5 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 posted24 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2017
- Study completionJun 2018
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
- Factorial
- Masking
- None (open label)
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital Gronau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nina Harke, MD., Principal investigator, St. Antonius Hospital GronauMustapha Addali, MD., Study chair, St. Antonius Hospital Gronau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812173
- Sponsor's protocol ID
- U4DGYZXT2DBN
- Acronym
- MPH
- Status last verified
- Dec 2022
- First submitted
- 18 May 2016
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Three-arm, Open Controlled Trial Comparing the Quality of Micturition and the Patient Comfort by Various Urinary Drainage After Robot-assisted Radical Prostatectomy (RARP)
- ClinicalTrials.gov ID
- NCT02812173
- Acronym / sponsor ID
- MPH / U4DGYZXT2DBN
- Conditions
- Prostate Cancer
- Keywords
- urinary drainage, urethral catheter, suprapubic tube, pain, discomfort, radical prostatectomy, robotic surgery, urinary infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- St. Antonius Hospital GronauUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 24 Jun 2016 (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 postoperative quality of micturition and continence can be improved depending on the urinary drainage catheter and retention after robot assisted radical prostatectomy. Another finding could be the study of the pain assessment of the patient, as well as the pain medication at the various derivatives. Further check whether infections and the presence of bacteriuria can be reduced or avoided by the form of urinary drainage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| suprapubic tube ex 2 day | Active comparator | Device: suprapubic tube ex 2 daypatients who underwent robot-assisted radical prostatectomy and got intraoperatively, a suprapubic tube, which was withdrawn on the 2th day after the surgery |
| suprapubic tube ex 5 day | Active comparator | Device: suprapubic tube ex 5 daypatients who underwent robot-assisted radical prostatectomy and got intraoperatively, a suprapubic tube, which was withdrawn on the 5th day after the surgery |
| transurethral catheter ex 5 day | Active comparator | Device: transurethral catheter ex 5 daypatients who underwent robot-assisted radical prostatectomy and got intraoperatively, a transurethral catheter, which was withdrawn on the 5th day after the surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Minimum age of 18 Years
- Voluntarily agreement to participate in this study
- filled in and signed Informed Consent
- release of medical records for regulatory or research purposes
- clinically organ-confined prostate cancer
Key exclusion criteria (6 listed)
- Participation in other interventional trials that could interfere with the present study
- International Prostate Symptom Score (IPPS) > 18
- History of radiation or chemotherapy
- History of transurethral prostate resection
- unable to provide informed consent
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 |
|---|---|---|
| suprapubic tube ex 2 dayAlso: Uromedballoon catheter for suprapubic bladder-drainage, suprapubic tube removal on the second day after the surgery | Device | suprapubic tube ex 2 day |
| suprapubic tube ex 5 dayAlso: Uromedballoon catheter for suprapubic bladder-drainage, suprapubic tube removal on the fifth day after the surgery | Device | suprapubic tube ex 5 day |
| transurethral catheter ex 5 dayAlso: Uromedtransurethral catheter withdrawal removal on the fifth day after the surgery | Device | transurethral catheter ex 5 day |
Primary outcome
Urinary leakage measured by pad test in grams
Time frame: within the day 2 or day 5 after the surgery for 24 hours
4 secondary outcomes
Detection of postoperative pain related to urinary drainage by numeric rating scale (NRS)
Time frame: once a day, first 7 days after the surgery
Recording of complications
Time frame: within the 4 weeks after surgery
Urine status measured by flow cytometry
Time frame: within the day 2 or day 5 after the surgery
Residual urine measured by bladder scan in ml
Time frame: 3 times within the day 2 or day 5 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 7 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Nina Harke, MD. principal investigator
St. Antonius Hospital Gronau
Mustapha Addali, 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 suprapubic tube ex 2 day, suprapubic tube ex 5 day and transurethral catheter ex 5 day 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 6 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 7 Dec 2022. 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?
Urinary leakage measured by pad test in grams (time frame: within the day 2 or day 5 after the surgery for 24 hours). 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 7 Dec 2022.