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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| balloon catheter for transurethral bladder-drainage | Experimental | intraoperatively placement of transurethral catheter after robot-assisted radical prostatectomy |
|
| balloon catheter for suprapubic bladder-drainage | Active Comparator | intraoperatively placement of suprapubic catheter after robot-assisted radical prostatectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| balloon catheter for suprapubic bladder-drainage | Device | suprapubic tube removal was allowed when the anastomosis was watertight, Day 5 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of postoperative pain related to urinary drainage objectified by numeric rating scale (NRS) questionnaire within 5 days | To analyse the development of the postoperative pain related to urinary drainage patients completed NRS questionnaire three times a day: in the morning, at noon and in the evening until discharge of the catheter (regular 5 days after the surgery) | postoperatively on day 1, 2, 3, 4 and 5 in the morning, at noon and in the evening |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with bacteriuria | Second void urine sample after catheter removal | 5th day after the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jawid Habibzada, MD. | St. Antonius Hospital Gronau | Study Chair |
| Michael Godes, MD. | St. Antonius Hospital Gronau | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, Pediatric Urology and Urologic Oncology; St. Antonius-Hospital Gronau GmbH | Gronau | 48599 | Germany |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D010146 | Pain |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| balloon catheter for transurethral bladder-drainage | Device | transurethral catheter withdrawal was allowed when the anastomosis was watertight, Day 5 |
|
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |