PainNCT01465594
Study Comparing Urinary Diversion (Transurethral/Suprapubic) After Radical Prostatectomy
A study testing transurethral catheter after EERPE/ RALP and suprapubic catheter after EERPE /RALP in people with Pain and Catheter Complications, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
The study aims to show the technical feasibility of the suprapubic urinary diversion after endoscopic extraperitoneal radical prostatectomy (EERPE) and has a greater comfort for the patients with at least the same catheter complication rate in comparison to the urethral urinary diversion. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Pain, Catheter Complications
- What is being tested?
- transurethral catheter after EERPE/ RALP and suprapubic catheter after EERPE /RALP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2011to Apr 2015
- 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
- Adenocarcinoma of the prostate,
- Subjects treated by conventional or robotic assisted laparoscopic prostatectomy
- Be willing/able to adhere to follow up visits
Who cannot join
- Subjects treated by retropubic or perineal prostatectomy Subjects with known bladder cancer
- Contraindications for anticholinergic drugs
- Waist measurement > 100 cm
- No written informed consent
- Age < 18 years
- Subjects with known narrow-angle glaucoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Study Comparing Urinary Diversion by Suprapubic Catheter With Transurethral Catheter in Patients After Radical Prostatectomy
The study aims to show the technical feasibility of the suprapubic urinary diversion after endoscopic extraperitoneal radical prostatectomy (EERPE) and has a greater comfort for the patients with at least the same catheter complication rate in comparison to the urethral urinary diversion.
Read the detailed description
Patients are randomized 1:1 in the different arms Recording of QoL measured by visual analogue ( pain )scale,EORTC QlQ -C 30 and QLQ - PR 25 questionnaires, incontinence rate, complication rate regarding insufficiency and strictures of vesicourethral anastomoses and urinary tract infection; demand of re-catheterization due to urinary retention and demand of antispasmodics
- Conditions
- Pain, Catheter Complications
- Being tested
- transurethral catheter after EERPE/ RALP, suprapubic catheter after EERPE /RALP
- Keywords
- Pain Measurement
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transurethral catheter after EERPE/ RALPProcedure or surgery
transurethral catheter after EERPE/ RALP
suprapubic catheter after EERPE /RALPProcedure or surgery
suprapubic catheter after EERPE /RALP
| Study group | Role | What they receive |
|---|---|---|
| transurethral catheter after EERPE/ RALP | Active comparator | Recording of QoL measured by visual analogue ( pain )scale,EORTC QlQ -C 30 and QLQ - PR 25 questionnaires, incontinence rate, complication rate regarding insufficiency and strictures of vesicourethral anastomoses and urinary tract infection; demand of re-catheterization due to urinary retention and demand of antispasmodics Receives: Procedure: transurethral catheter after EERPE/ RALP; Procedure: suprapubic catheter after EERPE /RALP |
| suprapubic catheter after EERPE /RALP | Active comparator | Recording of QoL measured by visual analogue ( pain )scale,EORTC QlQ -C 30 and QLQ - PR 25 questionnaires, incontinence rate, complication rate regarding insufficiency and strictures of vesicourethral anastomoses and urinary tract infection; demand of re-catheterization due to urinary retention and demand of antispasmodics Receives: Procedure: transurethral catheter after EERPE/ RALP; Procedure: suprapubic catheter after EERPE /RALP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superiority of suprapubic catheter after EERPE
Superiority of suprapubic catheter versus transurethral catheter regarding QoL /Patient comfort
Measured: 2nd postoperative day
Secondary outcomes (1)
Comparison of QoL in both arms measured by visual analogue (pain) scale
Comparison of QoL in both arms measured by visual analogue (pain) scale, EORTC QlQ -C 30 and QLQ - PR 25 questionnaires, incontinence rate, complication rate regarding insufficiency and strictures of vesicourethral anastomoses and urinary tract infection; demand of re-catheterization due to urinary retention and demand of antispasmodics.
Measured: 1st and 3rd until 5th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Arsov, Dr, Principal investigator, Heinrich Heine Universität
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465594
- Sponsor's protocol ID
- catheterstudy001
- Status last verified
- May 2015
- First submitted
- 2 Nov 2011
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Comparing Urinary Diversion by Suprapubic Catheter With Transurethral Catheter in Patients After Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT01465594
- Acronym / sponsor ID
- catheterstudy001
- Conditions
- Pain, Catheter Complications
- Keywords
- Pain Measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 7 Nov 2011 (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 study aims to show the technical feasibility of the suprapubic urinary diversion after endoscopic extraperitoneal radical prostatectomy (EERPE) and has a greater comfort for the patients with at least the same catheter complication rate in comparison to the urethral urinary diversion.
Detailed description
Patients are randomized 1:1 in the different arms Recording of QoL measured by visual analogue ( pain )scale,EORTC QlQ -C 30 and QLQ - PR 25 questionnaires, incontinence rate, complication rate regarding insufficiency and strictures of vesicourethral anastomoses and urinary tract infection; demand of re-catheterization due to urinary retention and demand of antispasmodics
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transurethral catheter after EERPE/ RALP | Active comparator | Procedure: transurethral catheter after EERPE/ RALP, Procedure: suprapubic catheter after EERPE /RALPRecording of QoL measured by visual analogue ( pain )scale,EORTC QlQ -C 30 and QLQ - PR 25 questionnaires, incontinence rate, complication rate regarding insufficiency and strictures of vesicourethral anastomoses and urinary tract infection; demand of re-catheterization due to urinary retention and demand of antispasmodics |
| suprapubic catheter after EERPE /RALP | Active comparator | Procedure: transurethral catheter after EERPE/ RALP, Procedure: suprapubic catheter after EERPE /RALPRecording of QoL measured by visual analogue ( pain )scale,EORTC QlQ -C 30 and QLQ - PR 25 questionnaires, incontinence rate, complication rate regarding insufficiency and strictures of vesicourethral anastomoses and urinary tract infection; demand of re-catheterization due to urinary retention and demand of antispasmodics |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adenocarcinoma of the prostate,
- Subjects treated by conventional or robotic assisted laparoscopic prostatectomy
- Be willing/able to adhere to follow up visits
Key exclusion criteria (6 listed)
- Subjects treated by retropubic or perineal prostatectomy Subjects with known bladder cancer
- Contraindications for anticholinergic drugs
- Waist measurement > 100 cm
- No written informed consent
- Age < 18 years
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 |
|---|---|---|
| transurethral catheter after EERPE/ RALPtransurethral catheter after EERPE/ RALP | Procedure or surgery | suprapubic catheter after EERPE /RALP, transurethral catheter after EERPE/ RALP |
| suprapubic catheter after EERPE /RALPsuprapubic catheter after EERPE /RALP | Procedure or surgery | suprapubic catheter after EERPE /RALP, transurethral catheter after EERPE/ RALP |
Primary outcome
Superiority of suprapubic catheter after EERPE
Time frame: 2nd postoperative day
Superiority of suprapubic catheter versus transurethral catheter regarding QoL /Patient comfort
1 secondary outcome
Comparison of QoL in both arms measured by visual analogue (pain) scale
Time frame: 1st and 3rd until 5th postoperative day
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 May 2015.
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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.
Christian Arsov, Dr principal investigator
Heinrich Heine Universität
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transurethral catheter after EERPE/ RALP and suprapubic catheter after EERPE /RALP in people with Pain and Catheter Complications, run by Heinrich-Heine University, Duesseldorf 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 3 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 20 May 2015. 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?
Superiority of suprapubic catheter after EERPE (time frame: 2nd postoperative day). 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 20 May 2015.