Skip to main content
OpenTrials
Completed

NCT Number: NCT04218942

Rocamed Urethral Device (RUD) and Urinary Retention in Males

Prospective non randomized study of the feasibility of the insertion of Rocamed urethral device by hand manipulation, i.e., without use of cystoscopy, sonography or fluoroscopy. Patients with an acute urinary retention treated by Foley catheterization in the Emergency department have a few days later a trial of Foley removal in the ambulatory unit of the Urology department. In case of failure of the Foley removal trial, i.e., recurrence of urinary retention, patients will be proposed either the insertion of a new Foley or insertion of the urethral device. After signature of an informed consent, insertion of the urethral device will be performed after instillation in the urethra of a local anesthetic gel. Device insertion success rate and complications will be studied. The device will be left in place for one month. Tolerance and complications during the month with the device in place will be studied. At one month the device will be removed: the ease of retrieval of the device and complications will be studied. Patient and doctor satisfaction with the urethral device will be compared to patient and doctor satisfaction with the Foley.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Service d'Urologie Hôpital Lyon Sud, Hospices Civils de Lyon

Pierre-Bénite, 69495, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male > 18 years old
  • Acute retention treated by Foley
  • Failure of Foley removal trial
  • Clear urine
  • No urinary infection
  • Efficient striated sphincter

Exclusion criteria

  • Urethral stenosis
  • Hematuria macroscopic
  • Urinary infection
  • Anticoagulant treatment
  • Lidocaine allergy

Treatment and study plan

Exime is the name of the single use temporary prostatic stent used instead of the Foley catheter

Device

Insertion after instillation of a local lubricant anesthetic gel in the urethra like for Foley insertion. Calibration of the urethral meatus with a 22F Bougie. Insertion of the Bougie until abutment against the posterior wall of the bulbous urethra just below the striated sphincter. Note depth of abutment on the scale of the Bougie. Retrieve the Bougie and glide the device to the same depth until abutment against the posterior wall of the bulbous urethra. At this stage the stent is correctly positioned. Stent release: unlock the Luer connection between pusher tube and stylet . Retrieve pusher tube, stylet and flattener tube.

Control of correct positioning: ask patient to stand up to verify the absence of any urine leak. Ask patient to void immediately to control clear urine output.

Primary outcomes

  1. Percentage of patients in whom the device will be inserted only by hand manipulation

    Time frame: Day 0

Secondary outcomes

  1. Patient tolerance during device insertion: analogic visual scale 0-10 (0 : no pain / 10 : worst pain imaginable)

    Time frame: Day 0 (Day of device insertion)

  2. Patient tolerance during one month: analogic visual scale 0-10 (0 : excellent tolerance / 10 : intolerable)

    Time frame: 1 Month

  3. Flowmetry with device in place ml/sec

    Time frame: Day 0 (Day of device insertion)

  4. Patient tolerance during retrieval of the device : analogic visual scale 0-10 (0 : no pain / 10 : worst pain imaginable)

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Interest of Rocamed Urethral Device for Treatment of Acute or Chronic Urinary Retention in Males

Acronym: RUD

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 6, 2020
Registry last updated
Sep 1, 2021

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.

Published trials that share one or more normalized conditions with this study.