Prostate Cancer
Conditions
Keywords
urinary drainage, urethral catheter, suprapubic tube, pain, discomfort, radical prostatectomy, robotic surgery, urinary infection
Brief 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. 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.
Interventions
DEVICEsuprapubic tube ex 2 day
balloon catheter for suprapubic bladder-drainage, suprapubic tube removal on the second day after the surgery
DEVICEsuprapubic tube ex 5 day
balloon catheter for suprapubic bladder-drainage, suprapubic tube removal on the fifth day after the surgery
DEVICEtransurethral catheter ex 5 day
transurethral catheter withdrawal removal on the fifth day after the surgery
Sponsors
St. Antonius Hospital Gronau
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary leakage measured by pad test in grams | within the day 2 or day 5 after the surgery for 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Detection of postoperative pain related to urinary drainage by numeric rating scale (NRS) | once a day, first 7 days after the surgery |
| Recording of complications | within the 4 weeks after surgery |
| Urine status measured by flow cytometry | within the day 2 or day 5 after the surgery |
| Residual urine measured by bladder scan in ml | 3 times within the day 2 or day 5 after the surgery |
Countries
Germany
Outcome results
None listed