Clinical trials: Urinary Catheter
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 Incontinence, Retention, Urinary
Performance of a Single-use Intermittent Micro-hole Zone Catheter
The goal of this randomized, controlled crossover study was to assess the performance of a new micro-hole zone catheter compared to a conventional 2-eyelet catheter in 42 male intermittent catheter users.
- Trial name
- NCT05485922
- Testing
- Investigational device - intermittent catheter with a micro-hole zone, Comparator device -VaPro intermittent catheter
- Where
- Denmark
- Volunteers
- 42 people
- Sponsor
- Coloplast A/S
Catheter-Associated Urinary Tract Infection
Efficacy of a Prepackaged Cleansing Cloth and Standardized Cleansing Protocol for Catheter Care at Reducing CAUTI Rates
Superiority study evaluating the efficacy of a prepackaged cleansing cloth and standardizing cleansing protocol vs. previous standard-of-care for catheter care and maintenance.
- Trial name
- NCT03645967
- Testing
- ReadyCleanse Cloths
- Where
- 4 sites in United States
- Volunteers
- 9,891 people, healthy volunteers welcome
- Sponsor
- Medline Industries
Neurogenic Bladder Dysfunction Nos
Quality of Life Intermittent Catheter Study
The purpose of this study is to compare compact intermittent catheters with standard coated intermittent catheters with regard to quality of life, using the Intermittent Self-Catheterisation Quality of life Measure.
- Trial name
- NCT01523743
- Testing
- SpeediCath Compact, Standard care
- Where
- 11 sites in Denmark, France and 3 more
- Volunteers
- 125 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
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
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
Neurogenic Bladder, Urinary Retention
Connected Catheter - Safety and Effectiveness Study
The Connected Catheter is a fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization.
- Conditions
- Neurogenic Bladder, Urinary Retention, Urologic Diseases
- Trial name
- NCT04059159
- Testing
- Connected Catheter
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Spinal Singularity
Catheterization
Study of a Urethral Catheter Coated With Eluting Silver Salts (SUCCESS)
Urinary catheters are often needed in hospital patients, but their use can increase the chance that a catheter associated urinary tract infection (called a CAUTI) may occur.
- Trial name
- SUCCESS (NCT00482547)
- Testing
- Hydrogel Silver Salts Coated Latex Urinary Catheter System, Bard silicone elastomer coated latex catheter system
- Where
- United States
- Volunteers
- 1,188 people
- Sponsor
- C. R. Bard
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
Urodynamics
e۰Sense® Catheter Clinical Investigation
This pre-market study will be conducted on consenting patients undergoing a medically prescribed, invasive, conventional urodynamics (UDS) test using the investigational device (e۰Sense® urodynamic catheters).
- Trial name
- NCT04438499
- Testing
- eSense 7fr Single Sensor Bladder Catheter
- Where
- 2 sites in France, Germany
- Volunteers
- 61 people
- Sponsor
- Laborie Medical Technologies Inc.
Urinary Retention
Use of The Spanner Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder Drainage in Men
The Spanner is being evaluated for use to manage voiding dysfunction and lower urinary tract symptoms in subjects to achieve bladder drainage in men unfit for other treatments.
- Trial name
- NCT02643849
- Testing
- The Spanner Temporary Prostatic Stent
- Where
- 6 sites in United States
- Volunteers
- 107 people
- Sponsor
- SRS Medical
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
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.
Urinary Incontinence
This Study Will Collect Clinical and Patient Reported Satisfaction Data From Males Requiring Urine Output Management Overnight in the Home Setting.
This post-market study will assess the performance of and user satisfaction with the PureWick® Male External Catheter in a home setting.
- Trial name
- PUREST-M (NCT06850259)
- Testing
- PureWick® Urine Collection System, UltraFlex™ Self-Adhering Male External Catheter
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- C. R. Bard
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.
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
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
Intermittent Urethral Catheterization
Safety and Performance of a New Coating for Urinary Intermittent Catheters
The aim of the study is to evaluate safety and performance of a new catheter coating,compared to the current SpeediCath coating.
- Trial name
- NCT01800903
- Testing
- ZN-D catheter, ZN-C catheter, SpeediCath catheter
- Where
- Denmark
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S