Rocamed Urethral Device (RUD) and Urinary Retention in Males

Civil Hospices of Lyon

Status: Completed

Conditions: Urinary Retention

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04218942

69HCL19_0395

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Prospective non randomised feasibility study

Experimental group

Treatment:

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