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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
suprapubic tube ex 2 day
suprapubic tube ex 5 day
transurethral catheter ex 5 day
Sponsored by
St. Antonius Hospital Gronau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring urinary drainage, urethral catheter, suprapubic tube, pain, discomfort, radical prostatectomy, robotic surgery, urinary infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

suprapubic tube ex 2 day

suprapubic tube ex 5 day

transurethral catheter ex 5 day

Arm Description

patients who underwent robot-assisted radical prostatectomy and got intraoperatively, a suprapubic tube, which was withdrawn on the 2th day after the surgery

patients who underwent robot-assisted radical prostatectomy and got intraoperatively, a suprapubic tube, which was withdrawn on the 5th day after the surgery

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who underwent robot-assisted radical prostatectomy and got intraoperatively, a transurethral catheter, which was withdrawn on the 5th day after the surgery

Outcomes

Primary Outcome Measures

Urinary leakage measured by pad test in grams

Secondary Outcome Measures

Detection of postoperative pain related to urinary drainage by numeric rating scale (NRS)
Recording of complications
Urine status measured by flow cytometry
Residual urine measured by bladder scan in ml

Full Information

First Posted
May 18, 2016
Last Updated
December 6, 2022
Sponsor
St. Antonius Hospital Gronau
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1. Study Identification

Unique Protocol Identification Number
NCT02812173
Brief Title
Postoperative Patient Comfort and Quality of Micturition in Suprapubic Tube vs. Transurethral Catheterization After RARP
Acronym
MPH
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 Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Antonius Hospital Gronau

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
urinary drainage, urethral catheter, suprapubic tube, pain, discomfort, radical prostatectomy, robotic surgery, urinary infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
234 (Actual)

8. Arms, Groups, and Interventions

Arm Title
suprapubic tube ex 2 day
Arm Type
Active Comparator
Arm Description
patients who underwent robot-assisted radical prostatectomy and got intraoperatively, a suprapubic tube, which was withdrawn on the 2th day after the surgery
Arm Title
suprapubic tube ex 5 day
Arm Type
Active Comparator
Arm Description
patients who underwent robot-assisted radical prostatectomy and got intraoperatively, a suprapubic tube, which was withdrawn on the 5th day after the surgery
Arm Title
transurethral catheter ex 5 day
Arm Type
Active Comparator
Arm Description
patients who underwent robot-assisted radical prostatectomy and got intraoperatively, a transurethral catheter, which was withdrawn on the 5th day after the surgery
Intervention Type
Device
Intervention Name(s)
suprapubic tube ex 2 day
Other Intervention Name(s)
Uromed
Intervention Description
balloon catheter for suprapubic bladder-drainage, suprapubic tube removal on the second day after the surgery
Intervention Type
Device
Intervention Name(s)
suprapubic tube ex 5 day
Other Intervention Name(s)
Uromed
Intervention Description
balloon catheter for suprapubic bladder-drainage, suprapubic tube removal on the fifth day after the surgery
Intervention Type
Device
Intervention Name(s)
transurethral catheter ex 5 day
Other Intervention Name(s)
Uromed
Intervention Description
transurethral catheter withdrawal removal on the fifth day after the surgery
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Detection of postoperative pain related to urinary drainage by numeric rating scale (NRS)
Time Frame
once a day, first 7 days after the surgery
Title
Recording of complications
Time Frame
within the 4 weeks after surgery
Title
Urine status measured by flow cytometry
Time Frame
within the day 2 or day 5 after the surgery
Title
Residual urine measured by bladder scan in ml
Time Frame
3 times within the day 2 or day 5 after the surgery

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nina Harke, MD.
Organizational Affiliation
St. Antonius Hospital Gronau
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mustapha Addali, MD.
Organizational Affiliation
St. Antonius Hospital Gronau
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Urology, Pediatric Urology and Urologic Oncology, St. Antonius Hospital Gronau
City
Gronau
ZIP/Postal Code
48599
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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