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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Heinrich-Heine University, Duesseldorf
Sponsor:
Information provided by (Responsible Party):
Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT01465594
First received: November 2, 2011
Last updated: August 18, 2014
Last verified: September 2012
  Purpose

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.


Condition Intervention
Pain
Catheter Complications
Procedure: transurethral catheter after EERPE/ RALP
Procedure: suprapubic catheter after EERPE /RALP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Randomized Study Comparing Urinary Diversion by Suprapubic Catheter With Transurethral Catheter in Patients After Radical Prostatectomy

Resource links provided by NLM:


Further study details as provided by Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • Superiority of suprapubic catheter after EERPE [ Time Frame: 2nd postoperative day ] [ Designated as safety issue: Yes ]
    Superiority of suprapubic catheter versus transurethral catheter regarding QoL /Patient comfort


Secondary Outcome Measures:
  • Comparison of QoL in both arms measured by visual analogue (pain) scale [ Time Frame: 1st and 3rd until 5th postoperative day ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 106
Study Start Date: November 2011
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Procedure: transurethral catheter after EERPE/ RALP
transurethral catheter after EERPE/ RALP
Procedure: suprapubic catheter after EERPE /RALP
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
Procedure: transurethral catheter after EERPE/ RALP
transurethral catheter after EERPE/ RALP
Procedure: suprapubic catheter after EERPE /RALP
suprapubic catheter after EERPE /RALP

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465594

Locations
Germany
University Hospital, Urological department Recruiting
Düsseldorf, Germany, 40225
Contact: Christian Arsov, Dr.    +49 (0) 211 81-19353    christian.arsov@med.uni-duesseldorf.de   
Principal Investigator: Christian Arsov, Dr.         
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
Principal Investigator: Christian Arsov, Dr Heinrich Heine Universität
  More Information

No publications provided

Responsible Party: Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT01465594     History of Changes
Other Study ID Numbers: catheterstudy001
Study First Received: November 2, 2011
Last Updated: August 18, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Heinrich-Heine University, Duesseldorf:
Pain Measurement

ClinicalTrials.gov processed this record on October 21, 2014