Clinical trials: Urinary Catheters
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
Lower Urinary Track Symptoms, Urodynamic Exam
e-Sense® Normal Values of Urodynamic Pressures Using e-Sense® Catheters
In this post-market observational study, subjects referred to urodynamic testing will be approached to enroll in a clinical study to define the normal range of pressure values utilizing e-Sense® catheters.
- Trial name
- ESNS-01 (NCT06905808)
- Testing
- eSense 7Fr Single Sensor Bladder Catheter
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- Laborie Medical Technologies Inc.
Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
Neuflo System for the Treatment of BPH
The goal of this clinical study is to assess the effectiveness and safety of the Neuflo System for the treatment of benign prostatic hyperplasia (BPH).
- Trial name
- NCT05884580
- Testing
- Neuflo BPH Treatment System
- Where
- New Zealand
- Volunteers
- 1 people
- Sponsor
- ProstaCare Pty Ltd
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
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
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
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
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.
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
Catheterization
Study Where Healthy Volunteers Evaluate LoFric Catheters
The purpose of this study is to evaluate healthy volunteers perception of catheterization with LoFric catheters with new solvents in the manufacturing process. The subjects will be catheterized three times during one visit day.
- Trial name
- NCT00802750
- Testing
- LoFric POBE
- Where
- Sweden
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Wellspect HealthCare
Urinary Tract Infections
Characterisation of Biofilm Growth on Coated vs. Uncoated Urinary Catheter Surfaces in Normal Clinical Use
1. Evaluated Patients: 5 patients (Convenience sample: non-blinded, non-randomised) Selection follows documented hospital protocols for routine catheterisation 2.
- Trial name
- PRO30CSP (NCT05513677)
- Testing
- M4D, Standard of Care
- Where
- United Kingdom
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Camstent Ltd.
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 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 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
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
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
Catheter-Associated Infection
Clinical Evaluation of Copesilcup
Healthcare-associated infections (HAIs): HAIs are a problem for all institutions and countries worldwide. Currently, one of the main infections is catheter-associated urinary tract infection (CAUTI).
- Trial name
- Copesilcup (NCT07530328)
- Testing
- PEGylated Silicone Urinary Catheter with Copper Nanoparticles (COPESILCUP), Control Device
- Where
- Chile
- Volunteers
- 256 people, healthy volunteers welcome
- Sponsor
- WMAS SpA
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
Catheter Infection, Catheter Blockage
Evaluation of the Novel Silq ClearTract Catheter in Patients With Chronic Urinary Retention
To assess the ability of the Silq ClearTract™ 100% Silicone 2-Way Foley Catheter to reduce catheter associated complications in subjects that require a long-term indwelling Foley catheter when compared to other commercially…
- Conditions
- Catheter Infection, Catheter Blockage, Catheter Related Complication, Catheter Calcification
- Trial name
- NCT05931887
- Testing
- SILQ ClearTract 100% Silicone 2-Way Foley Catheter
- Where
- United States
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- Silq Technologies Corporation
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