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

St. Antonius Hospital Gronau

Status: Completed

Conditions: Prostate Cancer

Treatments: Device: suprapubic tube ex 2 day; Device: suprapubic tube ex 5 day; Device: transurethral catheter ex 5 day

Study type: Interventional

Funder types: Other

Identifiers

NCT02812173

U4DGYZXT2DBN

Details and patient eligibility

About

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.

Enrollment: 234 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

234 participants in 3 patient groups

suprapubic tube ex 2 day

Active Comparator group

Description:

patients who underwent robot-assisted radical prostatectomy and got intraoperatively, a suprapubic tube, which was withdrawn on the 2th day after the surgery

Treatment:

Device: suprapubic tube ex 2 day

suprapubic tube ex 5 day

Active Comparator group

Description:

patients who underwent robot-assisted radical prostatectomy and got intraoperatively, a suprapubic tube, which was withdrawn on the 5th day after the surgery

Treatment:

Device: suprapubic tube ex 5 day

transurethral catheter ex 5 day

Active Comparator group

Description:

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who underwent robot-assisted radical prostatectomy and got intraoperatively, a transurethral catheter, which was withdrawn on the 5th day after the surgery

Treatment:

Device: transurethral catheter ex 5 day