Rocamed Urethral Device (RUD) and Urinary Retention in Males

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Completed
CT.gov ID
NCT04218942
Collaborator
(none)
15
1
1
12.6
1.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Exime is the name of the single use temporary prostatic stent used instead of the Foley catheter
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Interest of Rocamed Urethral Device for Treatment of Acute or Chronic Urinary Retention in Males
Actual Study Start Date :
Jun 12, 2020
Actual Primary Completion Date :
Jun 29, 2021
Actual Study Completion Date :
Jun 29, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Prospective non randomised feasibility study

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.

Outcome Measures

Primary Outcome Measures

  1. Percentage of patients in whom the device will be inserted only by hand manipulation [Day 0]

Secondary Outcome Measures

  1. Patient tolerance during device insertion: analogic visual scale 0-10 (0 : no pain / 10 : worst pain imaginable) [Day 0 (Day of device insertion)]

  2. Patient tolerance during one month: analogic visual scale 0-10 (0 : excellent tolerance / 10 : intolerable) [1 Month]

  3. Flowmetry with device in place ml/sec [Day 0 (Day of device insertion)]

  4. Patient tolerance during retrieval of the device : analogic visual scale 0-10 (0 : no pain / 10 : worst pain imaginable) [1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Service d'Urologie Hôpital Lyon Sud, Hospices Civils de Lyon Pierre-Bénite France 69495

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT04218942
Other Study ID Numbers:
  • 69HCL19_0395
First Posted:
Jan 6, 2020
Last Update Posted:
Sep 1, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospices Civils de Lyon
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 1, 2021