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Completed

NCT Number: NCT02108431

Prospective Randomized Trial Comparing Urinary Diversion After Robot-assisted Radical Prostatectomy

The purpose of the study is to determine, whether the urinary diversion via suprapubic cystostomy compared to transurethral catheterization after robot-assisted radical prostatectomy superior the postoperative patient comfort and reduce the postoperative bacteriuria.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology, Pediatric Urology and Urologic Oncology; St. Antonius-Hospital Gronau GmbH

Gronau, 48599, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Minimum age of 18 Years
  • Voluntarily agreement to participate in this study
  • Written informed-consent
  • Release of medical records for regulatory or research purposes
  • Clinically organ-confined prostate cancer

Exclusion criteria

  • BMI >40
  • History of catheterization
  • History of radiation
  • History of chemotherapy
  • Person's participating in any other research
  • Unable to provide informed consent

Treatment and study plan

balloon catheter for suprapubic bladder-drainage

Device

suprapubic tube removal was allowed when the anastomosis was watertight, Day 5

Other names: UROMED, suprapubic tube, suprapubic device

balloon catheter for transurethral bladder-drainage

Device

transurethral catheter withdrawal was allowed when the anastomosis was watertight, Day 5

Other names: UROMED

Primary outcomes

  1. Change of postoperative pain related to urinary drainage objectified by numeric rating scale (NRS) questionnaire within 5 days

    Time frame: postoperatively on day 1, 2, 3, 4 and 5 in the morning, at noon and in the evening

    To analyse the development of the postoperative pain related to urinary drainage patients completed NRS questionnaire three times a day: in the morning, at noon and in the evening until discharge of the catheter (regular 5 days after the surgery)

Secondary outcomes

  1. Number of patients with bacteriuria

    Time frame: 5th day after the surgery

    Second void urine sample after catheter removal

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital Gronau

Other

Registry information

Official study title

Superior Postoperative Patient Comfort in Suprapubic Drainage Versus Transurethral Catheterization Following Robot-assisted Radical Prostatectomy: A Prospective Randomized Clinical Trial

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 9, 2014
Registry last updated
Apr 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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