Postoperative Patient Comfort and Quality of Micturition in Suprapubic Tube vs. Transurethral Catheterization After RARP

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: suprapubic tube ex 2 day
* Device: suprapubic tube ex 5 day
* Device: transurethral catheter ex 5 day


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: suprapubic tube ex 2 day<br>patients who underwent robot-assisted radical prostatectomy and got intraoperatively, a suprapubic tube, which was withdrawn on the 2th day after the surgery | Device: suprapubic tube ex 2 day<br>* balloon catheter for suprapubic bladder-drainage, suprapubic tube removal on the second day after the surgery<br>* Other names: Uromed;|
| Active Comparator: suprapubic tube ex 5 day<br>patients who underwent robot-assisted radical prostatectomy and got intraoperatively, a suprapubic tube, which was withdrawn on the 5th day after the surgery | Device: suprapubic tube ex 5 day<br>* balloon catheter for suprapubic bladder-drainage, suprapubic tube removal on the fifth day after the surgery<br>* Other names: Uromed;|
| Active Comparator: transurethral catheter ex 5 day<br>patients who underwent robot-assisted radical prostatectomy and got intraoperatively, a transurethral catheter, which was withdrawn on the 5th day after the surgery | Device: transurethral catheter ex 5 day<br>* transurethral catheter withdrawal removal on the fifth day after the surgery<br>* Other names: Uromed;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary leakage measured by pad test in grams |  | within the day 2 or day 5 after the surgery for 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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suprapubic tube, urinary drainage, urethral catheter, pain, discomfort, radical prostatectomy, robotic surgery, urinary infection