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

December 6, 2022 updated by: St. Antonius Hospital Gronau

Prospective, Randomized, Three-arm, Open Controlled Trial Comparing the Quality of Micturition and the Patient Comfort by Various Urinary Drainage After Robot-assisted Radical Prostatectomy (RARP)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

234

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Gronau, Germany, 48599
        • Department of Urology, Pediatric Urology and Urologic Oncology, St. Antonius Hospital Gronau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Device: suprapubic tube ex 2 day
balloon catheter for suprapubic bladder-drainage, suprapubic tube removal on the second day after the surgery
Other Names:
  • Uromed
Active Comparator: 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
Device: suprapubic tube ex 5 day
balloon catheter for suprapubic bladder-drainage, suprapubic tube removal on the fifth day after the surgery
Other Names:
  • Uromed
Active Comparator: 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
Device: transurethral catheter ex 5 day
transurethral catheter withdrawal removal on the fifth day after the surgery
Other Names:
  • Uromed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Urinary leakage measured by pad test in grams
Time Frame: within the day 2 or day 5 after the surgery for 24 hours
within the day 2 or day 5 after the surgery for 24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Detection of postoperative pain related to urinary drainage by numeric rating scale (NRS)
Time Frame: once a day, first 7 days after the surgery
once a day, first 7 days after the surgery
Recording of complications
Time Frame: within the 4 weeks after surgery
within the 4 weeks after surgery
Urine status measured by flow cytometry
Time Frame: within the day 2 or day 5 after the surgery
within the day 2 or day 5 after the surgery
Residual urine measured by bladder scan in ml
Time Frame: 3 times within the day 2 or day 5 after the surgery
3 times within the day 2 or day 5 after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Antonius Hospital Gronau

Investigators

  • Principal Investigator: Nina Harke, MD., St. Antonius Hospital Gronau
  • Study Chair: Mustapha Addali, MD., St. Antonius Hospital Gronau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

May 18, 2016

First Submitted That Met QC Criteria

June 21, 2016

First Posted (Estimate)

June 24, 2016

Study Record Updates

Last Update Posted (Estimate)

December 7, 2022

Last Update Submitted That Met QC Criteria

December 6, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U4DGYZXT2DBN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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