Prospective Randomized Trial Comparing Urinary Diversion After Robot-assisted Radical Prostatectomy

NCT ID: NCT02108431

Last Updated: 2014-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-11-30

Brief Summary

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The purpose of the study is to determine, whether the urinary diversion via suprapubic cystostomy compared to transurethral catheterization after robot-assisted radical prostatectomy superior the postoperative patient comfort and reduce the postoperative bacteriuria.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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balloon catheter for transurethral bladder-drainage

intraoperatively placement of transurethral catheter after robot-assisted radical prostatectomy

Group Type EXPERIMENTAL

balloon catheter for transurethral bladder-drainage

Intervention Type DEVICE

transurethral catheter withdrawal was allowed when the anastomosis was watertight, Day 5

balloon catheter for suprapubic bladder-drainage

intraoperatively placement of suprapubic catheter after robot-assisted radical prostatectomy

Group Type ACTIVE_COMPARATOR

balloon catheter for suprapubic bladder-drainage

Intervention Type DEVICE

suprapubic tube removal was allowed when the anastomosis was watertight, Day 5

Interventions

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balloon catheter for suprapubic bladder-drainage

suprapubic tube removal was allowed when the anastomosis was watertight, Day 5

Intervention Type DEVICE

balloon catheter for transurethral bladder-drainage

transurethral catheter withdrawal was allowed when the anastomosis was watertight, Day 5

Intervention Type DEVICE

Other Intervention Names

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UROMED suprapubic tube suprapubic device UROMED

Eligibility Criteria

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Inclusion Criteria

1. Minimum age of 18 Years
2. Voluntarily agreement to participate in this study
3. Written informed-consent
4. Release of medical records for regulatory or research purposes
5. Clinically organ-confined prostate cancer

Exclusion Criteria

1. BMI \>40
2. History of catheterization
3. History of radiation
4. History of chemotherapy
5. Person's participating in any other research
6. Unable to provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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St. Antonius Hospital Gronau

OTHER

Sponsor Role lead

Responsible Party

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J.H. Witt

MD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jawid Habibzada, MD.

Role: STUDY_CHAIR

St. Antonius Hospital Gronau

Michael Godes, MD.

Role: STUDY_CHAIR

St. Antonius Hospital Gronau

Locations

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Department of Urology, Pediatric Urology and Urologic Oncology; St. Antonius-Hospital Gronau GmbH

Gronau, , Germany

Site Status

Countries

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Germany

Other Identifiers

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U1111-1155-1458

Identifier Type: -

Identifier Source: org_study_id

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