Clinical trials: Urinary Catheters
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
Urinary Retention, Catheter-Associated Urinary Tract Infection
Effectiveness and Cost-effectiveness of the T-Control® Catheter in Patients With Acute Urine Retention
The general purpose of this study is to assess the preliminary effectiveness and cost-effectiveness of the T-Control® catheter versus the Foley type catheter in patients with Acute Urine Retention.
- Conditions
- Urinary Retention, Catheter-Associated Urinary Tract Infection, Catheter Complications
- Trial name
- NCT05643950
- Testing
- Foley catheter, T-Control catheter
- Where
- 2 sites in Spain
- Sponsor
- Rethink Medical SL
Urinary Incontinence, Limited Mobility
An Observational, Multinational, In Hospital Evaluation of Catheter Utilization Rates in Female Patients Using Indwelling Urinary Catheters and the PureWick™ Flex Female External Catheter Across Europe and the Middle East
Urinary catheterization is commonly used in hospitalized patients for the management of urinary incontinence, immobilization, and monitoring of urinary output.
- Trial name
- REDUCE (NCT07798128)
- Testing
- PureWick™ Flex Female External Catheter (FFEC), Indwelling Urinary Catheter (IUC)
- Volunteers
- 240 people
- Sponsor
- Becton, Dickinson and Company
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.
Complications; Catheter, Urinary (Indwelling Catheter) (Suprapubic)
Prospective Cohort Study on Tolerability & Safety of Uro-Tainer® Polihexanide 0.02%
It is the first clinical study aimed at assessing the safety and tolerability of UT-P as routine rinsing and bacterial decolonization solution device for urinary catheters.
- Trial name
- NCT02157415
- Testing
- Uro-Tainer Polihexanide 0.02%
- Where
- 5 sites in Belgium, Germany and 1 more
- Volunteers
- 33 people
- Sponsor
- B. Braun Ltd. Centre of Excellence Infection Control
Urinary Tract Infections in Children
A Study of the PedSCath Pediatric Sampling Catheter Versus Current Standard of Care.
This is a retrospectively-controlled clinical trial that will examine the rate of positive UTI cases among pediatrics entered into the Emergency Department and whose urine is withdrawn using the PedSCath Pediatric Sampling…
- Trial name
- NCT04763967
- Testing
- PedSCath Pediatric Urinary Catheter, Standard of Care
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Big Blue Biotech, Inc.
Neurogenic Bladder
GentleCath™ Air Intermittent Catheter Smartwatch Real Life Pilot Study
As part of the ongoing Clinical Evaluation and Post Market Clinical Follow Up (PMCF) activities it was determined that a pilot study should be conducted to look at how real life data such as various physiological measurements can…
- Trial name
- NCT05683938
- Testing
- Intermittent self-catheterisation
- Where
- United Kingdom
- Volunteers
- 72 people
- Sponsor
- ConvaTec Inc.
Incontinence, Urinary
Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheters in Healthy Volunteers
The aim of the study is to test the performance and safety of a newly developed intermittent catheter
- Trial name
- NCT02965105
- Testing
- Coloplast Test Catheter, Speedicath
- Where
- Denmark
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Urinary Tract Infections
Efficacy of BLASTX in Catheter Associated Bacteriuria Versus Standard of Care (SOC)
This is a 2-week, single-site, randomized study in adults requiring short-term (≤ 14 days) catheterization. Subjects will be randomized 1:1 to either the biofilm disrupting gel (BLASTX) or SOC (McKesson Jelly) lubricated…
- Trial name
- NCT03176394
- Testing
- BLASTX Gel, McKesson Jelly
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Next Science TM
Neurogenic Bladder, Non-Neurogenic Bladder
Continence Care Registry
This observational research study aims to build a multinational electronic patient-reported outcomes (ePRO) registry of adult end users in outpatient and community settings using intermittent catheter(s) to void via the urethra…
- Trial name
- ConCaRe™ (NCT04924569)
- Where
- United States
- Volunteers
- 600 people
- Sponsor
- Hollister Incorporated
Incontinence, Urinary
Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheter in Healthy Volunteers
The aim of the study is to test the performance and safety of a newly developed intermittent catheter in healthy volunteers.
- Trial name
- NCT02965066
- Testing
- Coloplast Test Catheter, Coloplast Speedicath
- Where
- Denmark
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
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.
Urinary Catheter Blockage and Encrustation
Study to Evaluate NVC-422 for Urinary Catheter Blockage and Encrustation
NVC-422 is a topical, non-antibiotic, fast-acting, broad-spectrum anti-microbial, which exhibits the potential to prevent the growth of urinary pathogens, including Proteus and others.
- Trial name
- NCT01243125
- Testing
- NVC-422, 0.2%, Sterile normal saline, 0.9%
- Where
- 8 sites in United States
- Volunteers
- 67 people
- Sponsor
- NovaBay Pharmaceuticals, Inc.
Urinary Bladder, Neurogenic
Connected Catheter Clinical Feasibility Study( CFS)
The objective of this study is to evaluate the safety and essential performance of the Connected Catheter System in males with neurogenic lower urinary tract dysfunction (NLUTD), both in an acute clinical setting, and during and…
- Trial name
- NCT03405285
- Testing
- Connected Catheter
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Spinal Singularity
Urinary Catheters, Urinary Tract Infection
Clinical Study on Disposable Sterile Urinary Catheter
This study is a multicenter, randomized controlled study, with the urinary tract infection rate at the time of catheter insertion for 1 week as the primary end point.
- Trial name
- NCT05651217
- Testing
- disposable urinary catheter, super smooth antibacterial urinary catheter
- Where
- China
- Volunteers
- 136 people
- Sponsor
- Shandong Branden Med.Device Co.,Ltd
Urinary Retention
Study of the Criteria for Choosing Speedicath Catheters During the Initiation of Self-catheterization
To date, there is no objective data to help in the choice of the type of catheter to offer to the patient according to his or her needs.
- Trial name
- Eva (NCT05065255)
- Testing
- SpeediCath® catheters
- Where
- 38 sites in France
- Volunteers
- 250 people
- Sponsor
- Laboratoires Coloplast S.A.S
Urinary Catheter Blockage and Encrustation
Efficacy Study of Auriclosene Irrigation Solution on Urinary Catheter Patency
Long-term indwelling urinary catheters are associated with chronic recurrent urinary tract infections and blockage caused by crystalline biofilm accumulation (encrustation) of the catheter surfaces.
- Trial name
- NCT02130518
- Testing
- Auriclosene Irrigation Solution, 0.2%, Auriclosene Vehicle Solution
- Where
- 17 sites in United States
- Volunteers
- 140 people
- Sponsor
- NovaBay Pharmaceuticals, 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