Clinical trials: BLADDER CATHETERIZATION
Bacteriuria, Intermittent Catheterization
Open Prospective Study on Reduction of Bacteriuria Following Bladder Irrigation With Chlorhexidine
This a prospective, non-controlled, open, multi-center study evaluating the reduction of bacteriuria after bladder irrigation with chlorhexidine in spinal cord injured patients with chronic bacteriuria practicing intermittent…
- Trial name
- NCT01782404
- Testing
- Chlorhexidine
- Where
- 4 sites in Sweden
- Volunteers
- 50 people
- Sponsor
- Wellspect HealthCare
Urethral Catheter; Complications
Performance and Safety of Lubri-cream for Pain Minimization During Urethral Catheterization and Cystoscopy
The primary aim of this study is to collect clinical data on the performance of Lubri-cream applied in routine clinical practice.
- Trial name
- NCT06101121
- Testing
- Lubri-Cream
- Volunteers
- 120 people
- Sponsor
- B. Braun Medical SA
Spinal Cord Injuries, Multiple Sclerosis
GentleCath Air (Urinary Self-catheterization) - Pain in Female Patients With Neurological Vesico-sphincter Disorders
The purpose of this study is to evaluate the rate of occurrence of urethral pain in female patients with neurological vesico-sphincter disorders whilst performing self-catheterization using GentleCath™ Air catheters.
- Conditions
- Spinal Cord Injuries, Multiple Sclerosis, Parkinsonian Disorders, Allodynia
- Trial name
- FollowAir (NCT04847609)
- Testing
- GentleCath™ Air catheter
- Sponsor
- ConvaTec Inc.
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 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 Catheters, Urinary Catheterization
Effectiveness of the NowCath Foley in Reducing Catheter-Associated UTIs and Blockages in Long-Term Indwelling Catheter Users (REDUCE)
People who rely on long-term indwelling urinary (Foley) catheters often experience recurrent urinary tract infections and catheter blockages that require unscheduled catheter changes, additional antibiotics, and emergency visits.
- Conditions
- Urinary Catheters, Urinary Catheterization, Catheter-Related Infections, Catheter Associated Urinary Tract Infection
- Trial name
- REDUCE (NCT07782762)
- Testing
- NowCath Foley, Conventional All-Silicone Foley Catheter
- Where
- 3 sites in Denmark
- Volunteers
- 160 people
- Sponsor
- Nowwell AS
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
Bladder Dysfunction, Multiple Sclerosis
Efficacy of Clean Intermittent Catheterization (CIC) in Multiple Sclerosis (MS) Patients With Bladder Dysfunction
The aims of this prospective, randomized study are: To assess the effect of clean intermittent catheterization (CIC) To investigate if MS patients will have symptom reduction (urgency, frequency, nocturia and incontinence) when…
- Trial name
- NCT00913510
- Testing
- CIC using LoFric Primo, Anticholinergic medication
- Where
- 5 sites in Belgium, Germany and 2 more
- Volunteers
- 24 people
- Sponsor
- Wellspect HealthCare
Retention, Urinary
Exploratory Study Investigating the Urinary Bladder During Intermittent Catheterization in Healthy and Spinal Cord Injured Male and Female Subjects Using an Upright MRI Scanner
This is an exploratory study investigating morphological and physiological changes of the lower urinary tract and surrounding structures during IC use in individuals with SCI, and during normal voiding and IC use in healthy…
- Trial name
- NCT07384559
- Testing
- MRI scan
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
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
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
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 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
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 Incontinence, Multiple Sclerosis
Safety and Efficacy Study of OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity (NDO) in Non-Catheterizing Patients With Multiple Sclerosis (MS)
This study will evaluate the safety and efficacy of OnabotulinumtoxinA (BOTOX®) for the treatment of urinary incontinence due to NDO in non-catheterizing patients with MS.
- Conditions
- Urinary Incontinence, Multiple Sclerosis, Neurogenic Bladder
- Trial name
- NCT01600716
- Testing
- OnabotulinumtoxinA
- Where
- 10 sites in United States, Belgium and 6 more
- Volunteers
- 144 people
- Sponsor
- Allergan
Urinary Tract Infections
Study Comparing the DOVER Silver Foley Catheter to a Standard of Care Catheter and a Marketed Silver Coated Foley Catheter
The purpose of the study is to determine if the commercially available device called the DOVER™ Silver Foley catheter prevents infections of the urinary tract.
- Trial name
- NCT00203515
- Testing
- Standard Latex Foley Catheter, Silver Coated Latex Foley Catheter
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Tyco Healthcare Group
Intermittent Urethral Catheterization
Reuse of Intermittent Urethral Catheters
The purpose of this study is to investigate and document real life safety and satisfaction of re-use of urethral catheters for intermittent self catheterization.
- Trial name
- NCT02129738
- Testing
- LoFric catheters
- Where
- 7 sites in United States, Australia
- Volunteers
- 39 people
- Sponsor
- Wellspect HealthCare
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
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
Urinary Function
Investigate Bladder and Prostate During Emptying With Intermittent Catheter
Explorative study investigating the urinary bladder and prostate during intermittent catheterization in healthy male adults by use of MR-scanning.
- Trial name
- NCT05560594
- Testing
- Coloplast SpeediCath CH12 standard male intermittent catheter
- Where
- Denmark
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S