CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 16 enrolled
Drug / intervention
SpeediCath® Standard male +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04543136
NCT04543136N/ACompleted
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Exploratory Investigation on Performance and Safety of Newly Developed Intermittent Catheters in Male Users of Intermittent Catheters

Coloplast A/S·interventional·Posted Sep 9, 2020·Updated Jul 13, 2023

In Brief

A clinical study evaluating SpeediCath® Standard male, New intermittent Variant 1 catheter for males, and 1 other intervention for Retention, Urinary. Completed, enrolled 16 participants across 1 site.

Detailed Summary

Investigation of novel non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters for males with a comparator catheter

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRetention, Urinary
CountriesDenmark
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedSep 9, 2020
Enrollment StartOct 3, 2020
Primary CompletionJan 31, 2021
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 5.8 years ago

Interventions

SpeediCath® Standard maledevice

Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male.

New intermittent Variant 1 catheter for malesdevice

Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 catheter.

New intermittent Variant 2 catheter for malesdevice

Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 catheter.