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

Tracking Information

First Received Date ^ICMJE

November 2, 2011

Last Updated Date

September 10, 2012

Start Date ^ICMJE

November 2011

Estimated Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01465594 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Randomized Study Comparing Urinary Diversion by Suprapubic Catheter With Transurethral Catheter in Patients After Radical Prostatectomy

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Condition ^ICMJE

Pain
Catheter Complications

Intervention ^ICMJE

Procedure: transurethral catheter after EERPE/ RALP
transurethral catheter after EERPE/ RALP
Procedure: suprapubic catheter after EERPE /RALP
suprapubic catheter after EERPE /RALP

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

106

Estimated Completion Date

October 2013

Estimated Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01465594

Other Study ID Numbers ^ICMJE

catheterstudy001

Has Data Monitoring Committee

Responsible Party

Heinrich-Heine University, Duesseldorf

Study Sponsor ^ICMJE

Heinrich-Heine University, Duesseldorf

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Christian Arsov, Dr

Heinrich Heine Universität

Information Provided By

Heinrich-Heine University, Duesseldorf

Verification Date

September 2012

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

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