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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.
Patients are randomized 1:1 in the different arms Recording 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| transurethral catheter after EERPE/ RALP | Active Comparator | Recording 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 Comparator | Recording 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transurethral catheter after EERPE/ RALP | Procedure | transurethral catheter after EERPE/ RALP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Superiority of suprapubic catheter after EERPE | Superiority of suprapubic catheter versus transurethral catheter regarding QoL /Patient comfort | 2nd postoperative day |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of QoL in both arms measured by visual analogue (pain) scale | Comparison of QoL in both arms 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Arsov, Dr | Heinrich Heine Universität | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Urological department | Düsseldorf | 40225 | Germany |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| suprapubic catheter after EERPE /RALP | Procedure | suprapubic catheter after EERPE /RALP |
|
| 1st and 3rd until 5th postoperative day |