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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Device: suprapubic tube ex 2 day; Device: suprapubic tube ex 5 day; Device: transurethral catheter ex 5 day

• Registration Number: NCT02812173
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-18
• Study First Submitted QC: 2016-06-21
• Study First Posted: 2016-06-24
• Primary Completion: 2017-07
• Study Completion: 2018-06
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 234

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
suprapubic tube ex 2 day	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day	patients who underwent robot-assisted radical prostatectomy and got intraoperatively, a suprapubic tube, which was withdrawn on the 2th day after the surgery
suprapubic tube ex 5 day	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day	patients who underwent robot-assisted radical prostatectomy and got intraoperatively, a suprapubic tube, which was withdrawn on the 5th day after the surgery
transurethral catheter ex 5 day	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

Primary Outcome Measures

Name	Time	Method
Urinary leakage measured by pad test in grams	within the day 2 or day 5 after the surgery for 24 hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Urology, Pediatric Urology and Urologic Oncology, St. Antonius Hospital Gronau; 🇩🇪 Gronau, Germany