Clinical trials: Urinary Catheters
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
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 Tract Infection, Bacteriuria
Evaluation of Safety and Tolerability of Nitric Oxide Impregnated Urinary Catheters
According to the World Health Organization, hundreds of millions of patients are affected by health-care associated infections worldwide each year, resulting in prolonged hospital stays, long-term disabilities, deaths, and…
- Trial name
- NCT02277171
- Testing
- Nitric Oxide impregnated catheter
- Volunteers
- 15 people
- Sponsor
- Enox Israel Ltd
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
Consumer Evaluation of Intermittent Catheter Product Modifications
This study aims to collect feedback from hydrophilic intermittent catheter end-users to assess user acceptance of the test hydrophilic intermittent catheter and generate evidence to support commercial marketing objectives.
- Trial name
- NCT04619992
- Testing
- Currently marketed Hydrophillic Intermittent Catheter, Test Hydrophilic Intermittent Catheter
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- Hollister Incorporated
Benign Prostatic Hyperplasia
Effects Of Dutasteride On Risk Reduction Of Acute Urinary Retention Relapse Following Trial Without Catheter
The purpose of this study is to evaluate the efficacy and safety of dutasteride at reducing relapse rates of Acute Urinary Retention (AUR), including reduction in surgical intervention for benign prostatic hyperplasia (BPH), in…
- Trial name
- NCT00421421
- Testing
- Dutasteride
- Where
- 25 sites in United Kingdom
- Volunteers
- 276 people
- Sponsor
- GlaxoSmithKline
Urinary Tract Infections
The Effectiveness of a Bacteriophobic Coating on Urinary Catheters
To assess if a bacteriophobic coating prevents biofilm and host protein accumulation on urinary catheters and inflammatory protein release in urine following catheterization
- Trial name
- PRO033CSP (NCT05719753)
- Testing
- Camstent Coated Catheter, Standard Care
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- Camstent Ltd.
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
Neurogenic Bladder Dysfunction Nos
Quality of Life Intermittent Catheter Study
The purpose of this study is to compare compact intermittent catheters with standard coated intermittent catheters with regard to quality of life, using the Intermittent Self-Catheterisation Quality of life Measure.
- Trial name
- NCT01523743
- Testing
- SpeediCath Compact, Standard care
- Where
- 11 sites in Denmark, France and 3 more
- Volunteers
- 125 people
- Sponsor
- Coloplast A/S
Retention, Urinary
Investigation of Non-CE Marked Intermittent Catheters for Females
Investigation of novel non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters for females with a comparator catheter.
- Trial name
- NCT04557787
- Testing
- SpeediCath® Standard female, New intermittent Variant 1 catheter for females, New intermittent Variant 2 catheter for females
- Where
- Denmark
- Volunteers
- 15 people
- Sponsor
- Coloplast A/S
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
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
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
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 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
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
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
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
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.
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