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

NCT02108431 | Completed

• 1 other identifier: U1111-1155-1458
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

urinary diversion; urethral catheter; suprapubic tube; radical prostatectomy; robotic surgery; discomfort; pain

Outcome Measures

Primary Outcomes (1)

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

  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)

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

Secondary Outcomes (1)

• Number of patients with bacteriuria

  5th day after the surgery

Study Arms (2)

balloon catheter for transurethral bladder-drainage

EXPERIMENTAL

intraoperatively placement of transurethral catheter after robot-assisted radical prostatectomy

Device: balloon catheter for transurethral bladder-drainage

balloon catheter for suprapubic bladder-drainage

ACTIVE COMPARATOR

intraoperatively placement of suprapubic catheter after robot-assisted radical prostatectomy

Device: balloon catheter for suprapubic bladder-drainage

Interventions

balloon catheter for suprapubic bladder-drainage DEVICE

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

Also known as: UROMED, suprapubic tube, suprapubic device

balloon catheter for suprapubic bladder-drainage

balloon catheter for transurethral bladder-drainage DEVICE

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

Also known as: UROMED

balloon catheter for transurethral bladder-drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• St. Antonius Hospital Gronau: lead

Study Sites (1)

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

Gronau, 48599, Germany

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Jawid Habibzada, MD.

  St. Antonius Hospital Gronau

  STUDY CHAIR

• Michael Godes, MD.

  St. Antonius Hospital Gronau

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD.

Study Record Dates

• First Submitted: March 31, 2014
• First Posted: April 9, 2014
• Study Start: February 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: April 9, 2014

Record last verified: 2014-04

Locations

DE (1)