Rocamed Urethral Device (RUD) and Urinary Retention in Males

Not Applicable

Completed

• Conditions: Urinary Retention
• Interventions: Device: Exime is the name of the single use temporary prostatic stent used instead of the Foley catheter

• Registration Number: NCT04218942
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-03
• Study First Submitted QC: 2020-01-03
• Study First Posted: 2020-01-06
• Study Start: 2020-06-12
• Primary Completion: 2021-06-29
• Study Completion: 2021-06-29
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prospective non randomised feasibility study	Exime is the name of the single use temporary prostatic stent used instead of the Foley catheter	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients in whom the device will be inserted only by hand manipulation	Day 0

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Service d'Urologie Hôpital Lyon Sud, Hospices Civils de Lyon; 🇫🇷 Pierre-Bénite, France