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Rocamed Urethral Device (RUD) and Urinary Retention in Males (RUD)

Primary Purpose

Urinary Retention

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Exime is the name of the single use temporary prostatic stent used instead of the Foley catheter
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Retention focused on measuring Urethral Device, Foley catheterization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prospective non randomised feasibility study

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 3, 2020
Last Updated
August 31, 2021
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT04218942
Brief Title
Rocamed Urethral Device (RUD) and Urinary Retention in Males
Acronym
RUD
Official Title
Interest of Rocamed Urethral Device for Treatment of Acute or Chronic Urinary Retention in Males
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 12, 2020 (Actual)
Primary Completion Date
June 29, 2021 (Actual)
Study Completion Date
June 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention
Keywords
Urethral Device, Foley catheterization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prospective non randomised feasibility study
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Exime is the name of the single use temporary prostatic stent used instead of the Foley catheter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of patients in whom the device will be inserted only by hand manipulation
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Patient tolerance during device insertion: analogic visual scale 0-10 (0 : no pain / 10 : worst pain imaginable)
Time Frame
Day 0 (Day of device insertion)
Title
Patient tolerance during one month: analogic visual scale 0-10 (0 : excellent tolerance / 10 : intolerable)
Time Frame
1 Month
Title
Flowmetry with device in place ml/sec
Time Frame
Day 0 (Day of device insertion)
Title
Patient tolerance during retrieval of the device : analogic visual scale 0-10 (0 : no pain / 10 : worst pain imaginable)
Time Frame
1 month

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Service d'Urologie Hôpital Lyon Sud, Hospices Civils de Lyon
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France

12. IPD Sharing Statement

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Rocamed Urethral Device (RUD) and Urinary Retention in Males

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