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OpenTrials
Completed

NCT Number: NCT02812173

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

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.

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Key information

Conditions

Prostate Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Infections Male Urogenital Diseases Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Urinary Tract Infections Urogenital Diseases Urogenital Neoplasms Urologic Diseases

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

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
  • 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

Treatment and study plan

suprapubic tube ex 2 day

Device

balloon catheter for suprapubic bladder-drainage, suprapubic tube removal on the second day after the surgery

Other names: Uromed

suprapubic tube ex 5 day

Device

balloon catheter for suprapubic bladder-drainage, suprapubic tube removal on the fifth day after the surgery

Other names: Uromed

transurethral catheter ex 5 day

Device

transurethral catheter withdrawal removal on the fifth day after the surgery

Other names: Uromed

Primary outcomes

  1. Urinary leakage measured by pad test in grams

    Time frame: within the day 2 or day 5 after the surgery for 24 hours

Secondary outcomes

  1. Detection of postoperative pain related to urinary drainage by numeric rating scale (NRS)

    Time frame: once a day, first 7 days after the surgery

  2. Recording of complications

    Time frame: within the 4 weeks after surgery

  3. Urine status measured by flow cytometry

    Time frame: within the day 2 or day 5 after the surgery

  4. Residual urine measured by bladder scan in ml

    Time frame: 3 times within the day 2 or day 5 after the surgery

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital Gronau

Other

Registry information

Official study 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)

Acronym: MPH

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jun 24, 2016
Registry last updated
Dec 7, 2022

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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