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Completed

NCT Number: NCT01465594

Study Comparing Urinary Diversion (Transurethral/Suprapubic) After Radical Prostatectomy

The study aims to show the technical feasibility of the suprapubic urinary diversion after endoscopic extraperitoneal radical prostatectomy (EERPE) and has a greater comfort for the patients with at least the same catheter complication rate in comparison to the urethral urinary diversion.

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Key information

Conditions

Pain Catheter Complications Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Urological department

Düsseldorf, 40225, Germany

About this study

Patients are randomized 1:1 in the different arms Recording of QoL measured by visual analogue ( pain )scale,EORTC QlQ -C 30 and QLQ - PR 25 questionnaires, incontinence rate, complication rate regarding insufficiency and strictures of vesicourethral anastomoses and urinary tract infection; demand of re-catheterization due to urinary retention and demand of antispasmodics

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adenocarcinoma of the prostate,
  • Subjects treated by conventional or robotic assisted laparoscopic prostatectomy
  • Be willing/able to adhere to follow up visits

Exclusion criteria

  • Subjects treated by retropubic or perineal prostatectomy Subjects with known bladder cancer
  • Contraindications for anticholinergic drugs
  • Waist measurement > 100 cm
  • No written informed consent
  • Age < 18 years
  • Subjects with known narrow-angle glaucoma

Treatment and study plan

transurethral catheter after EERPE/ RALP

Procedure

transurethral catheter after EERPE/ RALP

suprapubic catheter after EERPE /RALP

Procedure

suprapubic catheter after EERPE /RALP

Primary outcomes

  1. Superiority of suprapubic catheter after EERPE

    Time frame: 2nd postoperative day

    Superiority of suprapubic catheter versus transurethral catheter regarding QoL /Patient comfort

Secondary outcomes

  1. Comparison of QoL in both arms measured by visual analogue (pain) scale

    Time frame: 1st and 3rd until 5th postoperative day

    Comparison of QoL in both arms measured by visual analogue (pain) scale, EORTC QlQ -C 30 and QLQ - PR 25 questionnaires, incontinence rate, complication rate regarding insufficiency and strictures of vesicourethral anastomoses and urinary tract infection; demand of re-catheterization due to urinary retention and demand of antispasmodics.

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Official study title

Randomized Study Comparing Urinary Diversion by Suprapubic Catheter With Transurethral Catheter in Patients After Radical Prostatectomy

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Nov 7, 2011
Registry last updated
May 20, 2015

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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