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Study Comparing Urinary Diversion (Transurethral/Suprapubic) After Radical Prostatectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01465594
First Posted: November 7, 2011
Last Update Posted: May 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Heinrich-Heine University, Duesseldorf
November 2, 2011
November 7, 2011
May 20, 2015
November 2011
April 2015   (Final data collection date for primary outcome measure)
Superiority of suprapubic catheter after EERPE [ Time Frame: 2nd postoperative day ]
Superiority of suprapubic catheter versus transurethral catheter regarding QoL /Patient comfort
Not Provided
Complete list of historical versions of study NCT01465594 on ClinicalTrials.gov Archive Site
Comparison of QoL in both arms measured by visual analogue (pain) scale [ Time Frame: 1st and 3rd until 5th postoperative day ]
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.
Not Provided
Not Provided
Not Provided
 
Study Comparing Urinary Diversion (Transurethral/Suprapubic) After Radical Prostatectomy
Randomized Study Comparing Urinary Diversion by Suprapubic Catheter With Transurethral Catheter in Patients After Radical Prostatectomy
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
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
  • Pain
  • Catheter Complications
  • Procedure: transurethral catheter after EERPE/ RALP
    transurethral catheter after EERPE/ RALP
  • Procedure: suprapubic catheter after EERPE /RALP
    suprapubic catheter after EERPE /RALP
  • Active Comparator: transurethral catheter after EERPE/ RALP
    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
    Interventions:
    • Procedure: transurethral catheter after EERPE/ RALP
    • Procedure: suprapubic catheter after EERPE /RALP
  • Active Comparator: suprapubic catheter after EERPE /RALP
    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
    Interventions:
    • Procedure: transurethral catheter after EERPE/ RALP
    • Procedure: suprapubic catheter after EERPE /RALP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
April 2015
April 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adenocarcinoma of the prostate,
  • Subjects treated by conventional or robotic assisted laparoscopic prostatectomy
  • Be willing/able to adhere to follow up visits

Exclusion Criteria:

  • Subjects treated by retropubic or perineal prostatectomy Subjects with known bladder cancer
  • Contraindications for anticholinergic drugs
  • Waist measurement > 100 cm
  • No written informed consent
  • Age < 18 years
  • Subjects with known narrow-angle glaucoma
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01465594
catheterstudy001
No
Not Provided
Not Provided
Heinrich-Heine University, Duesseldorf
Heinrich-Heine University, Duesseldorf
Not Provided
Principal Investigator: Christian Arsov, Dr Heinrich Heine Universität
Heinrich-Heine University, Duesseldorf
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP