Postoperative Patient Comfort and Quality of Micturition in Suprapubic Tube vs. Transurethral Catheterization After RARP

NCT ID: NCT02812173

Last Updated: 2022-12-07

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

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-06-30

Brief Summary

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The purpose of the study is to determine, whether the postoperative quality of micturition and continence can be improved depending on the urinary drainage catheter and retention after robot assisted radical prostatectomy. Another finding could be the study of the pain assessment of the patient, as well as the pain medication at the various derivatives. Further check whether infections and the presence of bacteriuria can be reduced or avoided by the form of urinary drainage.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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suprapubic tube ex 2 day

patients who underwent robot-assisted radical prostatectomy and got intraoperatively, a suprapubic tube, which was withdrawn on the 2th day after the surgery

Group Type ACTIVE_COMPARATOR

suprapubic tube ex 2 day

Intervention Type DEVICE

balloon catheter for suprapubic bladder-drainage, suprapubic tube removal on the second day after the surgery

suprapubic tube ex 5 day

patients who underwent robot-assisted radical prostatectomy and got intraoperatively, a suprapubic tube, which was withdrawn on the 5th day after the surgery

Group Type ACTIVE_COMPARATOR

suprapubic tube ex 5 day

Intervention Type DEVICE

balloon catheter for suprapubic bladder-drainage, suprapubic tube removal on the fifth day after the surgery

transurethral catheter ex 5 day

patients who underwent robot-assisted radical prostatectomy and got intraoperatively, a transurethral catheter, which was withdrawn on the 5th day after the surgery

Group Type ACTIVE_COMPARATOR

transurethral catheter ex 5 day

Intervention Type DEVICE

transurethral catheter withdrawal removal on the fifth day after the surgery

Interventions

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suprapubic tube ex 2 day

balloon catheter for suprapubic bladder-drainage, suprapubic tube removal on the second day after the surgery

Intervention Type DEVICE

suprapubic tube ex 5 day

balloon catheter for suprapubic bladder-drainage, suprapubic tube removal on the fifth day after the surgery

Intervention Type DEVICE

transurethral catheter ex 5 day

transurethral catheter withdrawal removal on the fifth day after the surgery

Intervention Type DEVICE

Other Intervention Names

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Uromed Uromed Uromed

Eligibility Criteria

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Inclusion Criteria

* Minimum age of 18 Years
* Voluntarily agreement to participate in this study
* filled in and signed Informed Consent
* release of medical records for regulatory or research purposes
* clinically organ-confined prostate cancer
* recommended and planned robot-assisted radical prostatectomy

Exclusion Criteria

* Participation in other interventional trials that could interfere with the present study
* International Prostate Symptom Score (IPPS) \> 18
* History of radiation or chemotherapy
* History of transurethral prostate resection
* unable to provide informed consent
* unwillingness to storage and forwarding of pseudonymous data
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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Responsibility Role SPONSOR

Principal Investigators

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Nina Harke, MD.

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital Gronau

Mustapha Addali, 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

Gronau, , Germany

Site Status

Countries

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Germany

Other Identifiers

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U4DGYZXT2DBN

Identifier Type: -

Identifier Source: org_study_id

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