Rocamed Urethral Device (RUD) and Urinary Retention in Males

Urinary Retention Clinical Trial

— RUD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04218942
• Other study ID #: 69HCL19_0395
• Status: Completed
• Phase: N/A
• Start date: June 12, 2020
• Est. completion date: June 29, 2021

Study information

• Verified date: August 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 29, 2021
• Est. primary completion date: June 29, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Retention

Intervention

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.

Locations

Country	Name	City	State
France	Service d'Urologie Hôpital Lyon Sud, Hospices Civils de Lyon	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients in whom the device will be inserted only by hand manipulation		Day 0
Secondary	Patient tolerance during device insertion: analogic visual scale 0-10 (0 : no pain / 10 : worst pain imaginable)		Day 0 (Day of device insertion)
Secondary	Patient tolerance during one month: analogic visual scale 0-10 (0 : excellent tolerance / 10 : intolerable)		1 Month
Secondary	Flowmetry with device in place ml/sec		Day 0 (Day of device insertion)
Secondary	Patient tolerance during retrieval of the device : analogic visual scale 0-10 (0 : no pain / 10 : worst pain imaginable)		1 month