Clinical trials: Urinary Catheters
Complications; Catheter, Urinary Infection or Inflammation
BIP Foley in Prevention of CAUTI at Rehab Station
This is a prospective, cross-over, randomized, controlled, partly blinded study evaluating safety and performance of noble metal alloy urinary Catheters (BIP Foley, Bactiguard AB) of both latex and silicone.
- Trial name
- CDOC (NCT02808000)
- Testing
- BIP Foley (latex) or BIP Foley -silicone, Standard catheter
- Where
- Sweden
- Volunteers
- 14 people
- Sponsor
- Bactiguard AB
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
Urinary Tract Infections
Study Comparing the DOVER Silver Foley Catheter to a Standard of Care Catheter and a Marketed Silver Coated Foley Catheter
The purpose of the study is to determine if the commercially available device called the DOVER™ Silver Foley catheter prevents infections of the urinary tract.
- Trial name
- NCT00203515
- Testing
- Standard Latex Foley Catheter, Silver Coated Latex Foley Catheter
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Tyco Healthcare Group
Bladder Infections and Inflammations
Chronic Indwelling Foley and Catheter Associated Trauma (CIF-CAT) Study
To determine whether an indwelling low profile Kohli Atraumatic Catheter causes less macro-morphologic inflammation and edema to the bladder mucosa than a traditional indwelling Foley catheter as assess by computerized image…
- Trial name
- NCT03790826
- Testing
- cystoscopy
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Nellie Medical, LLC
Urinary Retention
Comparison of Two Intermittent Urinary Catheters
This is an unblinded, multi-center, randomized, controlled, cross-over study assessing wheel-chair bound, male user preference and catheter characteristics of two intermittent urinary catheters.
- Trial name
- NCT01284361
- Testing
- 30 cm Intermittent Catheter, 40 cm Intermittent Catheter
- Where
- 4 sites in United States
- Volunteers
- 91 people
- Sponsor
- Hollister Incorporated
Non-muscle-invasive Bladder Cancer
T-Control® Safety for Cytostatics Management
The goal of this pilot clinical trial is to know if this study is feasable in terms of design, recruitment and interventions, as well as gather preliminary data to determine if the T-Control® catheter is safer than the…
- Trial name
- NCT06678633
- Testing
- T-Control® (experimental), Folysil® (control)
- Volunteers
- 16 people
- Sponsor
- Rethink Medical SL
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.
Female Intermittent Urethral Catheterization
Evaluation of a New Female Urinary Intermittent Catheter
A prospective, multi-centre, interventional study. All subjects will use the study device for two weeks and the angulated handle available with the device must be used by each subject at least 10 times.
- Trial name
- NCT04304599
- Testing
- LoFric Elle
- Where
- 4 sites in Spain, Sweden
- Volunteers
- 20 people
- Sponsor
- Wellspect HealthCare
Intermittent Urethral Catheterization
Clinical Study Evaluating the Safety of a New Catheter for Urinary Intermittent Catheterization in Self Catheterized Patients
The clinical study evaluates the safety of a new catheter for Urinary Intermittent Catheterisation in self catheterized patients
- Trial name
- NCT02911051
- Testing
- Actreen Hydrolite Cath
- Where
- France
- Volunteers
- 22 people
- Sponsor
- BBraun Medical SAS
Bacteriuria
The Impact Of A Catheter Coating On Clinical Bacteriuria
A prospective multicentre randomized study to assess the impact of a catheter coating on clinical bacteriuria when compared to an uncoated foley catheter.
- Trial name
- NCT04461262
- Testing
- Camstent Coated Catheter, Standard Care
- Where
- 4 sites in United Kingdom
- Volunteers
- 272 people
- Sponsor
- Camstent Ltd.
Urological
Feasibility Assessment of ACS Catheter
This is a single centre, non-randomised, baseline controlled, prospective pilot clinical trial to be undertaken at Rotherham General Hospital, Rotherham, UK.
- Trial name
- ACS1 (NCT01960517)
- Testing
- ACS Catheter
- Where
- United Kingdom
- Sponsor
- Alternative Urological Catheter Systems Ltd.
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
Urinary Incontinence
An Evaluation of the PureWick™ Male External Catheter Versus an Established Comparator Overnight in the Home Setting for Incontinence in Adult Males
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 (NCT07282860)
- Testing
- PureWick System, UltraFlex Self-Adhering Male External Catheter
- Where
- 15 sites in United States
- Volunteers
- 120 people
- Sponsor
- C. R. Bard
Urinary Function
Investigate Bladder and Prostate During Emptying With Intermittent Catheter
Explorative study investigating the urinary bladder and prostate during intermittent catheterization in healthy male adults by use of MR-scanning.
- Trial name
- NCT05560594
- Testing
- Coloplast SpeediCath CH12 standard male intermittent catheter
- Where
- Denmark
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Urinary Catheters
Patient Reported Outcome Study on Long Term LoFric Users
A prospective, observational cohort study evaluating Patient Reported Outcome in subjects with a long term experience from intermittent catheterization using the LoFric catheter.
- Trial name
- NCT05359198
- Volunteers
- 98 people
- Sponsor
- Wellspect HealthCare
Urinary Incontinence
An Exploratory Investigation of the Effects of Single Use vs. Reuse Catheters in Intermittent Catheterization
The overall aim of the investigation is to investigate the effect of repeated reuse of intermittent urinary catheters and to observe the impact of switch from single use to multiple reuse catheters.
- Trial name
- NCT05626686
- Testing
- CLINY catheter
- Where
- Denmark
- Volunteers
- 40 people
- Sponsor
- Coloplast A/S
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
Urinary Retention, Neurogenic Bladder
Connected Catheter (C2P) Study for Bladder Management
The objective of this study is to evaluate the safety and essential performance of the C2P System in males with neurogenic lower urinary tract dysfunction (NLUTD), both in an acute clinical setting and an extended period of home…
- Trial name
- NCT03626324
- Testing
- C2P
- Where
- 8 sites in United States
- Volunteers
- 27 people
- Sponsor
- Spinal Singularity
Bladder Outlet Obstruction, Multiple Sclerosis
GentleCath™ for Men Intermittent Catheter With FeelClean™ Technology
Male self catherterisng observational study.
- Conditions
- Bladder Outlet Obstruction, Multiple Sclerosis, Cauda Equina Syndrome, Enlarged Prostate With Lower Urinary Tract Symptoms
- Trial name
- NCT05470751
- Testing
- Intermittent self-catheterisation
- Where
- 16 sites in United States, France and 1 more
- Volunteers
- 72 people
- Sponsor
- ConvaTec Inc.
Catheter-Associated Urinary Tract Infection, Catheter Related Complication
Comparative Study Between Foley and T-Control® Catheter in Patients With Long-term Catheterization
This is a comparative, randomized, controlled pilot study. The main objective of this study is to evaluate the efficacy, comfort, and patient experience in people with long-term bladder catheterization with T-Control® versus…
- Conditions
- Catheter-Associated Urinary Tract Infection, Catheter Related Complication, Quality of Life
- Trial name
- NCT05860231
- Testing
- Foley catheter, T-Control catheter
- Where
- 2 sites in Spain
- Volunteers
- 50 people
- Sponsor
- Rethink Medical SL