Clinical trials: Urinary Catheters
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.
Urinary Retention, Neurogenic Bladder
Consumer Evaluation of an Investigational Intermittent Catheter
This clinical study is designed to evaluate the initial safety and performance of an investigational intermittent urinary catheter in people who use intermittent catheterization.
- Trial name
- NCT07714694
- Testing
- An intermittent urethral urinary catheter with a tip, tube and drainage eyelets
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Hollister Incorporated
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 Catheters, Bladder Pain and Discomfort
FLUME Catheter Comfort Study
The Flume catheter is a commercially available (FDA 510(k) cleared) urethral catheter with an innovative catheter design. The traditional Foley catheter design includes a protruding tip with drainage holes.
- Conditions
- Urinary Catheters, Bladder Pain and Discomfort, Urine Leakage, Bladder Spasm
- Trial name
- NCT05785858
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- The Flume Catheter Company Ltd
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.
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
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.
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
Adult Nocturnal Enuresis, Urinary Incontinence (UI)
This Study Will Collect Clinical and Patient Reported Experience Data From Participants Requiring Urine Output Management Overnight in the Home Setting.
This post-market study will assess the performance of and user experience with the PureWick™ System in a home setting. The study will also observe safety of the study device and collect information from participants about their…
- Trial name
- PUREST (NCT06666426)
- Testing
- PureWick System, Hollister Female Urinary Pouch External Collection Device
- Where
- 15 sites in United States
- Volunteers
- 171 people
- Sponsor
- C. R. Bard
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.
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
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.
Bacteriuria
A Pilot Study To Assess The Impact Of A Camstent Coated Catheter On Clinical Bacteriuria
A Pilot Study To Assess The Impact Of A Camstent Coated Catheter On Clinical Bacteriuria when compared to an uncoated catheter. Each participant will take part in the trial from the time the participant signs the informed consent…
- Trial name
- CAM-SPC-001 (NCT04658719)
- Testing
- Camstent Coated Catheter, Standard Care
- Volunteers
- 30 people
- Sponsor
- Camstent Ltd.
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
Neurogenic Bladder Disorder, Non-Neurogenic Bladder
Define Final Selection Choice Criteria for a Coloplast Catheter Ensuring Highest Patient Satisfaction Via Surveys (EVA).
Understanding the Coloplast Intermittent Catheter Selection Study: This study aims to understand how adults who need to use catheters to empty their bladder by themselves decide which Coloplast catheter works best for them.
- Conditions
- Neurogenic Bladder Disorder, Non-Neurogenic Bladder, Bladder Dysfunction, Urinary Retention
- Trial name
- EVA (NCT07355803)
- Testing
- Questionnaires : Patient questionnaire on catheter use and satisfaction, IC-Di-Q, and I-CAT
- Where
- Belgium
- Volunteers
- 22 people
- Sponsor
- Coloplast NV/SA
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 Retention
Assessment of CymActive™ Catheter Technology for UrinAry ReTention and AcceptancE (The ACCTUATE Study)
The ACCTUATE study: Assessment of CymActive™ Catheter Technology for UrinAry reTention and acceptancE study will evaluate a novel catheter design that addresses the specific needs of male long term catheter users living in the…
- Trial name
- ACCTUATE (NCT05848037)
- Testing
- cymactive™ catheter device (CCD), Foley-type catheter device
- Where
- 5 sites in United Kingdom
- Volunteers
- 6 people
- Sponsor
- Ingenion Medical Limited
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
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.
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.