Rocamed Urethral Device (RUD) and Urinary Retention in Males

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-12

Study Completion Date

2021-06-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Urinary Retention

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prospective non randomised feasibility study

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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