CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
SpeediCath® Standard female +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/NCT04557787
NCT04557787N/ACompleted
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Exploratory Investigation on Performance and Safety of Newly Developed Intermittent Catheters in Female Users of Intermittent Catheters

Coloplast A/S·interventional·Posted Sep 22, 2020·Updated Sep 21, 2023

In Brief

A clinical study evaluating SpeediCath® Standard female, New intermittent Variant 1 catheter for females, and 1 other intervention for Retention, Urinary. Completed, enrolled 15 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 females with a comparator catheter.

Study Details

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

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedSep 22, 2020
Enrollment StartDec 1, 2020
Primary CompletionMay 31, 2021
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 5.8 years ago

Interventions

SpeediCath® Standard femaledevice

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

New intermittent Variant 1 catheter for femalesdevice

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

New intermittent Variant 2 catheter for femalesdevice

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