Study Comparing Urinary Diversion (Transurethral/Suprapubic) After Radical Prostatectomy
Randomized Study Comparing Urinary Diversion by Suprapubic Catheter With Transurethral Catheter in Patients After Radical Prostatectomy
1 other identifier
interventional
106
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pain
Started Nov 2011
Longer than P75 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 2, 2011
CompletedFirst Posted
Study publicly available on registry
November 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedMay 20, 2015
May 1, 2015
3.4 years
November 2, 2011
May 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Superiority of suprapubic catheter after EERPE
Superiority of suprapubic catheter versus transurethral catheter regarding QoL /Patient comfort
2nd postoperative day
Secondary Outcomes (1)
Comparison of QoL in both arms measured by visual analogue (pain) scale
1st and 3rd until 5th postoperative day
Study Arms (2)
transurethral catheter after EERPE/ RALP
ACTIVE COMPARATORRecording 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 COMPARATORRecording 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
Interventions
transurethral catheter after EERPE/ RALP
suprapubic catheter after EERPE /RALP
Eligibility Criteria
You may qualify if:
- Adenocarcinoma of the prostate,
- Subjects treated by conventional or robotic assisted laparoscopic prostatectomy
- Be willing/able to adhere to follow up visits
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital, Urological department
Düsseldorf, 40225, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian Arsov, Dr
Heinrich Heine Universität
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2011
First Posted
November 7, 2011
Study Start
November 1, 2011
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
May 20, 2015
Record last verified: 2015-05