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

History of Changes

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 May 21, 2013

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