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

Prostate Cancer Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02812173
• Other study ID #: U4DGYZXT2DBN
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: June 2018

Study information

• Verified date: December 2022
• Source: St. Antonius Hospital Gronau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: June 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• suprapubic tube ex 2 day
balloon catheter for suprapubic bladder-drainage, suprapubic tube removal on the second day after the surgery
• suprapubic tube ex 5 day
balloon catheter for suprapubic bladder-drainage, suprapubic tube removal on the fifth day after the surgery
• transurethral catheter ex 5 day
transurethral catheter withdrawal removal on the fifth day after the surgery

Locations

Country	Name	City	State
Germany	Department of Urology, Pediatric Urology and Urologic Oncology, St. Antonius Hospital Gronau	Gronau

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital Gronau

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary leakage measured by pad test in grams		within the day 2 or day 5 after the surgery for 24 hours
Secondary	Detection of postoperative pain related to urinary drainage by numeric rating scale (NRS)		once a day, first 7 days after the surgery
Secondary	Recording of complications		within the 4 weeks after surgery
Secondary	Urine status measured by flow cytometry		within the day 2 or day 5 after the surgery
Secondary	Residual urine measured by bladder scan in ml		3 times within the day 2 or day 5 after the surgery