Postoperative Patient Comfort and Quality of Micturition in Suprapubic Tube vs. Transurethral Catheterization After RARP
MPH
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)
1 other identifier
interventional
234
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable prostate-cancer
Started May 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 18, 2016
CompletedFirst Posted
Study publicly available on registry
June 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedDecember 7, 2022
December 1, 2022
1.2 years
May 18, 2016
December 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Urinary leakage measured by pad test in grams
within the day 2 or day 5 after the surgery for 24 hours
Secondary Outcomes (4)
Detection of postoperative pain related to urinary drainage by numeric rating scale (NRS)
once a day, first 7 days after the surgery
Recording of complications
within the 4 weeks after surgery
Urine status measured by flow cytometry
within the day 2 or day 5 after the surgery
Residual urine measured by bladder scan in ml
3 times within the day 2 or day 5 after the surgery
Study Arms (3)
suprapubic tube ex 2 day
ACTIVE COMPARATORpatients who underwent robot-assisted radical prostatectomy and got intraoperatively, a suprapubic tube, which was withdrawn on the 2th day after the surgery
suprapubic tube ex 5 day
ACTIVE COMPARATORpatients who underwent robot-assisted radical prostatectomy and got intraoperatively, a suprapubic tube, which was withdrawn on the 5th day after the surgery
transurethral catheter ex 5 day
ACTIVE COMPARATORpatients who underwent robot-assisted radical prostatectomy and got intraoperatively, a transurethral catheter, which was withdrawn on the 5th day after the surgery
Interventions
balloon catheter for suprapubic bladder-drainage, suprapubic tube removal on the second day after the surgery
balloon catheter for suprapubic bladder-drainage, suprapubic tube removal on the fifth day after the surgery
transurethral catheter withdrawal removal on the fifth day after the surgery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Urology, Pediatric Urology and Urologic Oncology, St. Antonius Hospital Gronau
Gronau, 48599, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nina Harke, MD.
St. Antonius Hospital Gronau
- STUDY CHAIR
Mustapha Addali, MD.
St. Antonius Hospital Gronau
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2016
First Posted
June 24, 2016
Study Start
May 1, 2016
Primary Completion
July 1, 2017
Study Completion
June 1, 2018
Last Updated
December 7, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share