NCT04218942: RUD

Rocamed Urethral Device (RUD) and Urinary Retention in Males

Completed NA Last updated 1 September 2021

What this trial tests

NA trial testing Exime is the name of the single use temporary prostatic stent used instead of the Foley catheter in Urinary Retention in 15 participants. Completed in 29 June 2021.

Timeline

12 June 2020

Primary endpoint
29 June 2021

29 June 2021

Quick facts

Lead sponsor	Hospices Civils de Lyon
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	12 June 2020
Primary completion	29 June 2021
Estimated completion	29 June 2021
Sites	1 location across France

Drugs / interventions tested

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

Conditions studied

• Urinary Retention — all drugs for Urinary Retention →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, male only, with Urinary Retention. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Feasibility of EXIME® temporary prosthesis placement and removal in men with acute or chronic urinary retention after failure or inability to selfcatheterize.
   Charbonnel C, Neuville P, Paparel P, Reichenbach A, et al · · 2022 · cited 6× · PMID 35672221 · DOI 10.1016/j.purol.2022.04.012