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

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ClinicalTrials.gov Identifier: NCT02812173
Recruitment Status : Unknown
Verified June 2016 by St. Antonius Hospital Gronau.
Recruitment status was:  Recruiting
First Posted : June 24, 2016
Last Update Posted : July 22, 2016
Sponsor:
Information provided by (Responsible Party):
St. Antonius Hospital Gronau

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: suprapubic tube ex 2 day Device: suprapubic tube ex 5 day Device: transurethral catheter ex 5 day Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : May 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : June 2017

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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patients who underwent robot-assisted radical prostatectomy and got intraoperatively, a suprapubic tube, which was withdrawn on the 2th day after the surgery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 Name: 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patients who underwent robot-assisted radical prostatectomy and got intraoperatively, a suprapubic tube, which was withdrawn on the 5th day after the surgery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 Name: 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 Name: Uromed




Primary Outcome Measures :
  1. Urinary leakage measured by pad test in grams [ Time Frame: within the day 2 or day 5 after the surgery for 24 hours ]

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812173


Contacts
Contact: Katarina Urbanova, Dr. katarina.urbanova@st-antonius-gronau.de
Contact: Petra Lange lange@st-antonius-gronau.de

Locations
Germany
Department of Urology, Pediatric Urology and Urologic Oncology, St. Antonius Hospital Gronau Recruiting
Gronau, Germany, 48599
Sponsors and Collaborators
St. Antonius Hospital Gronau
Investigators
Principal Investigator: Nina Harke, MD. St. Antonius Hospital Gronau
Study Chair: Mustapha Addali, MD. St. Antonius Hospital Gronau

Responsible Party: St. Antonius Hospital Gronau
ClinicalTrials.gov Identifier: NCT02812173     History of Changes
Other Study ID Numbers: U4DGYZXT2DBN
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: July 22, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by St. Antonius Hospital Gronau:
urinary drainage
urethral catheter
suprapubic tube
pain
discomfort
radical prostatectomy
robotic surgery
urinary infection