Clinical trials: Urinary Catheters
Urinary Incontinence
Intermittent Catheterisation on the Bladder Mucosa of Healthy Volunteers With a Prototype Micro Hole Zone Catheter
This investigation is a randomized, single-blinded, parallel, single-center investigation. In total, up to 50 subjects (40 completers) were included and each subject had two test visits overseen by the Principal Investigator…
- Trial name
- CP341 (NCT05224544)
- Testing
- Investigational prototype device, Comparator device
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Catheterization
A Comparison of Two Urinary Catheters of Different Lengths for Female Use, in Intermittent Catheterization
A study comparing a 10 cm catheter with a 7 cm catheter in a group of female patients who, on a routine bases, empty their bladder using urinary catheters, by measuring residual urine after intermittent catheterization.
- Trial name
- NCT00799981
- Testing
- A=SpeediCath Compact 7 cm and B=POBE 10 cm
- Where
- 3 sites in Sweden
- Volunteers
- 60 people
- Sponsor
- Wellspect HealthCare
Urinary Catheterization
A Study Evaluating a Urinary Catheter With Different Activation Times for the Wetting Solution, in Healthy Male Volunteers.
The primary purpose of this study is to compare the subject's perception (separately for each randomized catheter) of practicing catheterization when using catheters with sodium chloride in wetting solution (using two different…
- Trial name
- NCT00748033
- Testing
- Reference catheter: LoFric PVC, Nelaton 40 cm, CH 12, LoFric POBE Hydro-Kit II, 5 seconds, LoFric POBE Hydro-Kit II, 24 hours
- Where
- Sweden
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Wellspect HealthCare
Urinary Incontinence
Clinical Trial of New Intermittent Single-use Catheter
A multi-centre, open-labelled, randomised, crossover design. The total study duration for the individual subject will be approximately 4 weeks, consisting of four site visits and two 2-week test periods at home.
- Trial name
- NCT05814211
- Testing
- Investigational device - newly developed intermittent catheter, Comparator device #1 - SpeediCath Eve, Comparator device #2 - SpeediCath Compact Plus Female
- Where
- 11 sites in Denmark, France and 1 more
- Volunteers
- 82 people
- Sponsor
- Coloplast A/S
Urinary Incontinence
Consumer Evaluation of Intermittent Catheter Product Modifications
This study aims to collect feedback from hydrophilic intermittent catheter end-users to assess user acceptance of the test hydrophilic intermittent catheter and generate evidence to support commercial marketing objectives.
- Trial name
- NCT04619992
- Testing
- Currently marketed Hydrophillic Intermittent Catheter, Test Hydrophilic Intermittent Catheter
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- Hollister Incorporated
Incontinence, Urge
T-DOC® 5 Fr Pediatric Clinical Investigation
A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects
- Trial name
- NCT03429270
- Testing
- TDOC 5Fr
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Laborie Medical Technologies Inc.
Retention, Urinary
Investigation of Non-CE Marked Intermittent Catheters for Females
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.
- Trial name
- NCT04557787
- Testing
- SpeediCath® Standard female, New intermittent Variant 1 catheter for females, New intermittent Variant 2 catheter for females
- Where
- Denmark
- Volunteers
- 15 people
- Sponsor
- Coloplast A/S
Urinary Retention
A Confirmatory Study Confirming Performance of a New Intermittent Catheter
A multi-centre, randomized, controlled crossover design. The total study duration for the individual subject was approximately 9 weeks.
- Trial name
- NCT05485935
- Testing
- Investigational device - intermittent catheter with micro-hole zone, Comparator - standard intermittent catheter
- Where
- 6 sites in Denmark, France and 2 more
- Volunteers
- 73 people
- Sponsor
- Coloplast A/S
Catheterization (Clean, Intermittent Urinary Catheterization)
Evaluation of a New Catheter Material for Intermittent Catheterization
The hypothesis to be investigated is if the tolerability of intermittent catheterization with Polyolefin Based Elastomer (POBE) 2.0 and Polyvinyl Chloride (PVC) is clinically equal - i.e.
- Trial name
- NCT01295281
- Testing
- LoFric POBE 2.0, LoFric PVC
- Where
- 6 sites in Sweden
- Volunteers
- 107 people
- Sponsor
- Wellspect HealthCare
Retention, Urinary
New Coating for Urinary Intermittent Catheters
The goal is to confirm, that the newly developed coating is non-inferior to the comparator with respect to the overall discomfort of the catheterisation (assessed by participant).
- Trial name
- NCT06985888
- Testing
- SpeediCath® Standard male new coating, SpeediCath® Standard male
- Where
- Denmark
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy
Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter
A prospective, non-randomized study. The subjects will be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. The post-treatment follow-up visit can be up to 5 years.
- Trial name
- EVEREST-I (NCT03423979)
- Testing
- Optilume™ BPH Prostatic DCB Dilation Catheter, Paclitaxel
- Where
- 5 sites in Dominican Republic, Panama
- Volunteers
- 80 people
- Sponsor
- Urotronic Inc.
Urinary Catheterization
A Randomized, Fully-blinded Parallel Groups Study of Catheter Materials Used for Clean Intermittent Catheterisation
The study is designed as a randomized, double-blind, parallel-group, multi centre study comparing perception and tolerability of investigational product and comparator.
- Trial name
- NCT00753298
- Testing
- LoFric Primo (POBE) single-use urinary catheter, LoFric Primo (PVC) single-use urinary catheter
- Where
- 13 sites in Austria, Germany and 4 more
- Volunteers
- 195 people
- Sponsor
- Wellspect HealthCare
Incontinence, Urge
T-DOC® NXT Clinical Investigation
Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies
- Trial name
- NCT03615001
- Testing
- TDOC NXT
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Laborie Medical Technologies Inc.
Incontinence, Urinary
Product Evaluation of a Newly Developed Intermittent Catheter.
The aim of the study is to investigate the navigation of a newly developed catheter.
- Trial name
- NCT02966015
- Testing
- Coloplast test catheter
- Volunteers
- 153 people
- Sponsor
- Coloplast A/S
Urinary Incontinence
Bladder Scan of Residual Urine With New Catheter
Male intermittent catheters (ICs) range from 340-500 mm long, with the European standard minimum length being 360 mm for a catheter without a balloon and 275 mm for one with a balloon.
- Trial name
- NCT01048541
- Testing
- Test Catheter - SpeediCath Compact Male, SpeediCath
- Where
- Germany
- Volunteers
- 37 people
- Sponsor
- Coloplast A/S
Urinary Tract Infections
Comparative Study of Intermittent Catheters and Occurrence of Urinary Tract Infections
The purpose of this study is to investigate the frequency of urinary tract infections with symptoms in spinal cord injured patients requiring intermittent catheterization for emptying the bladder.
- Trial name
- NCT00318591
- Testing
- SpeediCath, Conveen Uncoated
- Where
- 16 sites in United States, Canada
- Volunteers
- 219 people
- Sponsor
- Coloplast A/S
Retention, Urinary
Investigation of New Intermittent Catheters in Healthy Volunteers
Investigation of non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters with a comparator catheter in 30 adult healthy volunteers.
- Trial name
- NCT04445051
- Testing
- SpeediCath® Standard male or female, New intermittent Variant 1 catheter for male or female, New intermittent Variant 2 catheter for male or female
- Where
- Denmark
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Retention, Urinary
Investigation of Non-CE Marked Intermittent Catheters.
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
- Trial name
- NCT04543136
- Testing
- SpeediCath® Standard male, New intermittent Variant 1 catheter for males, New intermittent Variant 2 catheter for males
- Where
- Denmark
- Volunteers
- 16 people
- Sponsor
- Coloplast A/S
Urinary Incontinence
Clinical Trial of New Single-use Compact Intermittent Catheter
The study is a randomised, single-blinded, controlled crossover study. The total study duration for the individual subject will be between two days - two weeks, consisting of three site visits.
- Trial name
- NCT05841004
- Testing
- Investigational device, Comparator device
- Where
- Denmark
- Volunteers
- 73 people
- Sponsor
- Coloplast A/S
Catheter Site Pain, Catheter Site Discomfort
Investigation of New Intermittent Catheter Swelling Media in Healthy Volunteers
Investigation of novel swelling media for CE marked intermittent urinary catheters. The study was a randomized, single blinded, cross-over investigation comparing a novel swelling media with a comparator swelling media in 22…
- Trial name
- NCT04633291
- Testing
- Novel swelling media, Comparator swelling media
- Where
- Denmark
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S