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

S

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patients who underwent robot-assisted radical prostatectomy and got intraoperatively, a suprapubic tube, which was withdrawn on the 2th day after the surgery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patients who underwent robot-assisted radical prostatectomy and got intraoperatively, a suprapubic tube, which was withdrawn on the 5th day after the surgery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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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