Clinical trials: Urinary Catheters
Urinary Retention, Neurogenic Bladder
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
- Urinary Retention, Neurogenic Bladder, Urologic Diseases
- Trial name
- NCT03843073
- Testing
- Connected Urinary Catheter
- Where
- 9 sites in United States
- Volunteers
- 9 people
- Sponsor
- Spinal Singularity
Urinary Incontinence
Bladder Scan of Residual Urine With New Catheter
Male intermittent catheters (ICs) range from 340-500 mm long, with the European standard minimum length being 360 mm for a catheter without a balloon and 275 mm for one with a balloon.
- Trial name
- NCT01048541
- Testing
- Test Catheter - SpeediCath Compact Male, SpeediCath
- Where
- Germany
- Volunteers
- 37 people
- Sponsor
- Coloplast A/S
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
Bladder Voiding Dysfunction
User Satisfaction When Catheterizing With Hydrophilic Urinary Catheters From a More Sustainable Manufacturing Process.
An open, prospective, single arm, multicenter clinical investigation. All subjects will use the investigational device for 30 days each.
- Trial name
- NCT04703413
- Testing
- LoFric® OrigoTM and LoFric® SenseTM
- Where
- 3 sites in Germany
- Volunteers
- 50 people
- Sponsor
- Wellspect HealthCare
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
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.
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
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
Retention, Urinary
Investigation of Non-CE Marked Intermittent Catheters.
Investigation of novel non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters for males with a comparator catheter
- Trial name
- NCT04543136
- Testing
- SpeediCath® Standard male, New intermittent Variant 1 catheter for males, New intermittent Variant 2 catheter for males
- Where
- Denmark
- Volunteers
- 16 people
- 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
Urinary Retention, Chronic
Evaluation of the Safety and Clinical Performance of the Connected Catheter Study
The objective of this study is to evaluate the safety and effectiveness of the Connected Catheter in males with chronic Urinary Retention, both in a clinical setting and an extended period of home use.
- Trial name
- NCT05330598
- Testing
- Connected Catheter
- Where
- 5 sites in United States
- Volunteers
- 26 people
- Sponsor
- Spinal Singularity
Urinary Incontinence
UK PureWick™ At-Home Pilot Study
The UK PureWick™ At-Home Study is being carried out to see how well the PureWick™ Collection System works for women who use it at home instead of a traditional catheter. Traditional catheters are placed inside the body.
- Trial name
- NCT07555548
- Testing
- Treatment with the PureWick™ Urine Collection System External Catheter which is a non-invasive device designed to manage urinary incontinence
- Where
- 4 sites in United Kingdom
- Volunteers
- 95 people
- Sponsor
- Becton, Dickinson and Company
Critical Illness, Burns
Effect of Active Drain Line Clearance on Catheter-Associated Bacteriuria
Catheter-associated urinary tract infections (CAUTI) are the most common nosocomial infections in critically ill patients and are responsible for high morbidity rates, increased hospital stays and associated costs.
- Conditions
- Critical Illness, Burns, Surgery, Urinary Tract Infections
- Trial name
- CAB (NCT03816384)
- Testing
- Standard of Care, DLC Group, DLCS Group
- Sponsor
- Potrero 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
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
Catheter Infection, Complications; Catheter
COMPARISON OF KOHLI AND FOLEY CATHETERS IN SUPRAPUBIC CATHETER PATIENTS
The purpose of this medical research study is to compare two different urinary drainage catheters to see which has fewer problems with blockages and pain.
- Trial name
- NCT03897959
- Testing
- Kohli vs Foley catheter
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Nellie Medical, LLC
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
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
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