Clinical trial · Interventional
Prospective Randomized Trial Comparing Urinary Diversion After Robot-assisted Radical Prostatectomy
Superior Postoperative Patient Comfort in Suprapubic Drainage Versus Transurethral Catheterization Following Robot-assisted Radical Prostatectomy: A Prospective Randomized Clinical Trial
NCT02108431CI-TRIAL-00014214completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| balloon catheter for suprapubic bladder-drainage | Device | — | UNRESOLVED |
| balloon catheter for transurethral bladder-drainage | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- balloon catheter for transurethral bladder-drainage
- description
- intraoperatively placement of transurethral catheter after robot-assisted radical prostatectomy
- interventionNames
- Device: balloon catheter for transurethral bladder-drainage
- type
- ACTIVE_COMPARATOR
- label
- balloon catheter for suprapubic bladder-drainage
- description
- intraoperatively placement of suprapubic catheter after robot-assisted radical prostatectomy
- interventionNames
- Device: balloon catheter for suprapubic bladder-drainage
Primary outcomes (1)
- measure
- Change of postoperative pain related to urinary drainage objectified by numeric rating scale (NRS) questionnaire within 5 days
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Minimum age of 18 Years 2. Voluntarily agreement to participate in this study 3. Written informed-consent 4. Release of medical records for regulatory or research purposes 5. Clinically organ-confined prostate cancer Exclusion Criteria: 1. BMI \>40 2. History of catheterization 3. History of radiation 4. History of chemotherapy 5. Person's participating in any other research 6. Unable to provide informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.