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

NCT ID: NCT01465594

Last Updated: 2015-05-20

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

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2015-04-30

Brief Summary

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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

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Patients are randomized 1:1 in the different arms 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

Conditions

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Pain Catheter Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

transurethral catheter after EERPE/ RALP

Intervention Type PROCEDURE

transurethral catheter after EERPE/ RALP

suprapubic catheter after EERPE /RALP

Intervention Type PROCEDURE

suprapubic catheter after EERPE /RALP

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

Group Type ACTIVE_COMPARATOR

transurethral catheter after EERPE/ RALP

Intervention Type PROCEDURE

transurethral catheter after EERPE/ RALP

suprapubic catheter after EERPE /RALP

Intervention Type PROCEDURE

suprapubic catheter after EERPE /RALP

Interventions

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transurethral catheter after EERPE/ RALP

transurethral catheter after EERPE/ RALP

Intervention Type PROCEDURE

suprapubic catheter after EERPE /RALP

suprapubic catheter after EERPE /RALP

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian Arsov, Dr

Role: PRINCIPAL_INVESTIGATOR

Heinrich Heine Universität

Locations

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University Hospital, Urological department

Düsseldorf, , Germany

Site Status

Countries

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Germany

Other Identifiers

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catheterstudy001

Identifier Type: -

Identifier Source: org_study_id

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