Rocamed Urethral Device (RUD) and Urinary Retention in Males

NCT04218942 | Completed

• 1 other identifier: 69HCL19_0395
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Retention

Keywords

Urethral Device; Foley catheterization

Outcome Measures

Primary Outcomes (1)

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

  Day 0

Secondary Outcomes (4)

• 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

Study Arms (1)

Prospective non randomised feasibility study

EXPERIMENTAL

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

Interventions

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.

Prospective non randomised feasibility study

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 6, 2020
• Study Start: June 12, 2020
• Primary Completion: June 29, 2021
• Study Completion: June 29, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Locations

FR (1)