Rocamed Urethral Device (RUD) and Urinary Retention in Males (RUD)

Interest of Rocamed Urethral Device for Treatment of Acute or Chronic 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.

Study Overview

• Status: Completed
• Conditions: Urinary Retention
• Intervention / Treatment: Device: Exime is the name of the single use temporary prostatic stent used instead of the Foley catheter

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pierre-Bénite, France, 69495
    • Service d'Urologie Hôpital Lyon Sud, Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Prospective non randomised feasibility study

Device: Exime is the name of the single use temporary prostatic stent used instead of the Foley catheter; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients in whom the device will be inserted only by hand manipulation	Day 0

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient tolerance during device insertion: analogic visual scale 0-10 (0 : no pain / 10 : worst pain imaginable)	Day 0 (Day of device insertion)
Patient tolerance during one month: analogic visual scale 0-10 (0 : excellent tolerance / 10 : intolerable)	1 Month
Flowmetry with device in place ml/sec	Day 0 (Day of device insertion)
Patient tolerance during retrieval of the device : analogic visual scale 0-10 (0 : no pain / 10 : worst pain imaginable)	1 month

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2020
• Primary Completion (Actual): June 29, 2021
• Study Completion (Actual): June 29, 2021

Study Registration Dates

• First Submitted: January 3, 2020
• First Submitted That Met QC Criteria: January 3, 2020
• First Posted (Actual): January 6, 2020

Study Record Updates

• Last Update Posted (Actual): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Urethral Device; Foley catheterization
• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Urinary Retention
• Other Study ID Numbers: 69HCL19_0395

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No