Trial record 2 of 3 for:    Open Studies | "Urinary Diversion"

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

This study is currently recruiting participants.
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: September 10, 2012
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

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 2013
Estimated Primary Completion Date: October 2012 (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
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: September 10, 2012
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on April 17, 2014